Inflammatory Bowel DiseaseNCT01781481
The Pediatric Intermed: A New Clinical Decision Making Tool
An observational study of Inflammatory Bowel Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Inflammatory Bowel Disease
- How many people
- 148 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Aug 2014
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: All children between the ages of 8 and 17 who are followed in the CHEO GI Clinic and who have been diagnosed with an Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitus). Once diagnosed, children are followed on an ongoing basis in the clinic for management of their chronic illness, with the frequency of follow-up appointments varying depending on the nature and course of a child's disease. Both parents of the subjects will be invited to participate in the study, although if only one parent is present only they will be included. If a child/youth is in foster placement, consent will be obtained from child protection officials to have the caregiver (s) most involved with the child/youth participate in the interview.
Who may be able to join
- diagnosis of IBD (Crohn's or Ulcerative Colitis)
- fluency in English or French
- between the ages of 8 and 17
- residing in the CHEO catchment area.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With Inflammatory Bowel Disease
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.
Read the detailed description
Inflammatory Bowel Disease (Crohn's disease/ulcerative colitis) manifests itself in children and adolescents in up to 1/3 of those that will eventually develop these conditions. It is fast becoming an increasing problem with a 50% increase in Crohn's disease diagnosed in young children in the last decade. The patient's chronic symptoms can be both due to and result in increased child and family psychosocial stress. Similarly, treatments may add to psychosocial stress. Failure to address these psychosocial issues can lead to greater risk for poor treatment adherence, higher utilization of health care, and increased psychiatric co-morbidity. As such, improvement in health care providers' capacity to identify factors contributing to case complexity offers significant potential for improving outcomes.
Assessment of biological, psychological, social and health delivery of children's chronic illness has not been consistently integrated into the health care system. Physical and mental health services are often disconnected. Identifying those who would benefit from a mental health referral typically rests on the primary care physician or specialist and is often triggered by crises. There is also variability in physician education and comfort level in assessing psychosocial issues and especially in children with chronic illnesses in which symptoms of physical disease and mental health can overlap. Oftentimes this leaves the most responsible physician wanting for a simple assessment tool to try and determine who might be at risk and benefit from mental health intervention.
The adult INTERMED is a clinical decision-support tool that provides indicators of biological, psychological, social, heath care needs, as well as an overall index of case complexity. The tool is efficient to administer and has been successfully used by varied health care professionals in diverse medical settings to detect psychosocial needs, facilitate referral to effective services and improve health practices and outcomes. However, there is no comparable validated tool for use with children/youth.
The investigators have recently developed a pediatric adaptation of the adult INTERMED to address the unique developmental and social contexts of children and youth. A Delphi group of international experts in the field of pediatric chronic illness has reviewed the instrument to ensure clinical relevance, utility and communication clarity. Initial pilot data has demonstrated the Pediatric INTERMED has very good item inter-rater reliability. The focus of the current study is to examine the usefulness of this tool to identify biopsychosocial needs in IBD children/youth. Canada has a very high IBD incidence and prevalence. Given the facts that children with IBD face an unpredictable disease course, complex symptoms and difficult management regimens that can significantly impact their lives, it is not surprising that patients with this chronic incurable condition are highly vulnerable to mental health comorbidities. The development of this new tool will have significant importance if it proves to be useful in this population. The current study will examine a sizeable cohort of patients with regards to the relations between Pediatric INTERMED domains and other measures of children's disease, mood, behaviour, quality of life, family stress and strengths, and health services utilization. Both ulcerative colitis and Crohn's disease in children and youth lend themselves very well to this study because of the validated measures of disease severity that have been developed already.
Implementation of the novel Pediatric INTERMED n clinical practice will provide a new way to assist IBD Teams in screening their patients to be proactive in referral to mental health resources, and facilitate case management which targets patient needs. Clearly, clinicians are well aware that compliance, anxiety and depression will affect disease outcomes and too often these are only dealt with at times of crisis that has led to disease flare or reports that medicines are no longer effective. Use of this structured assessment tool begins to realize the potential of developing a truly integrated biopsychosocial approach to this chronic disease. The ease of use and objective nature of the tool will enhance communication among primary and tertiary providers and contribute to best practice approaches in the provision of integrated physical and mental health care. It will also assist in monitoring the impact of childhood chronic illness, identify factors linked to optimal health outcomes and inform program planning and resource allocations.
Study Design
Children/youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern Ontario (CHEO) with confirmed diagnoses of IBD (Crohn's disease or ulcerative colitis) are eligible for the study. A clinical nurse will complete the Pediatric INTERMED for all study participants: based on information obtained from a review of the patients' hospital chart and a semi-structured interview conducted with the child/youth and primary caregivers), Following the Pediatric INTERMED interview, children/youth and parents participating in the project will complete a battery of self-report instruments to provide assessments of patients' social and psychological functioning, parent/family stresses, adjustment and resources. In addition, information will be obtained from the patients' charts about aspects of their diagnoses, treatment regimens, disease activity and complications, and health care utilization in the 3 months prior to their participation in the study.
Primary Hypotheses/Objectives and Statistical Rationale
- Demonstrate that the Pediatric INTERMED is a reliable tool for use in IBD children (good inter-rater reliability and internal consistency). 40 interviews with the clinical research nurse will be videotaped so that a second health care professional trained in the use of the PIM, can also complete the PIM tool, in order to examine inter-rater reliability. Agreement between raters will be measured by means of intraclass correlations. Items within each domain will be examined to confirm that they meet internal consistency criteria (Cronbach's Alpha of .80).
- Demonstrate that the Pediatric INTERMED domains successfully identify patient needs. Concurrent validity of the Pediatric INTERMED will be examined by looking at the Spearman rank, Pearson correlations, as appropriate, between each domain score and the measures hypothesized to be conceptually linked to the domain. To assess aspects of the Psychological Domain, the patients will complete the Children's Depression Inventory, the Multidimensional Anxiety Scale for Children and parents will complete the Child Behaviour Checklist (CBCL). Measures linked to the Social Domain of the PIM, include The Functional Disability Inventory, which taps the child's involvement in daily activities, and CBCL Competence Scores (Social, School, Activities), and the IMPACT-III, an IBD specific quality of life measure. To examine constructs linked to the Caregiver/Family Domain parents will complete the Pediatric Inventory for Parents, an index of childhood illness-related parenting stress, the Family Inventory of Life Events and Changes and the Family Inventory of Resources for Management. Disease/treatment and health care data gathered will be used to validate the Biological and Health System Domains.
- Demonstrate that Pediatric INTERMED Complexity score is predictive of increased health care utilization. A general linear approach will be used to study the relation of the Pediatric INTERMED to health service utilization. Multivariate models will also be tested including potential covariates such as disease severity, time since diagnosis.
Statistical Power Calculations
The CHEO GI clinic sees 40 to 60 new patients diagnosed with IBD per year. In 2007 the clinic actively followed 265 children with IBD. Once diagnosed children are followed on an ongoing basis. The frequency of follow-up appointments varies depending on the nature and course of a child's disease, but the children/youth are seen at minimum three times each year. In general, participation rates in studies of children/youth with chronic illness are typically in the vicinity of 80-90% or better and this figure is consistent with the experience of the CHEO IBD clinic in the recruitment of patients into various knowledge generation studies. The PIM involves 5 domains of information inclusive of various components. To achieve significance with the various domains the investigators estimated that a total of 140-150 children will need to be enrolled. This sample size is sufficient to ensure that there are a sufficient number of observations per variable to conduct multivariate analyses. Tabachnick and Fidell (2007) and others indicated that 4 is the absolute minimum number of observations per variable to conduct multivariate analyses. A subject size of 140-150 would be sufficient to provide 4 observations per variable. Further, the anticipated sample size is sufficient to conduct all proposed analyses. Further corrections for multiple testing will be applied on a per-analysis basis.
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Psychosocial Stress and Adjustment, Pediatric Chronic Illness, Decision-support tool, Integrated Health Care, Case Complexity
- Medical subject headings
- Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children and youth with IBD | Children/youth (ages 8-17) with confirmed diagnoses of IBD. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pediatric INTERMED- Complexity Index
34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action).
Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains:
Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity).
Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity).
Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity).
Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity).
Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).
Measured: Time of Study Participation (Completion of Pediatric INTERMED tool)
Correlations Between Pediatric INTERMED Domain Scores
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.
Measured: Pediatric INTERMED scores at time of study participation
Pediatric INTERMED Items
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.
Measured: Day 1 (At time of Pediatric Intermed Interview)
IBD Disease Severity
IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Time Since IBD Diagnosis
Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.
Measured: Data collected through chart review at time of Pediatric INTERMED interview.
Disease Course and Treatment
Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).
Measured: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)
IBD Treatment With Immunomodulators or Anti-TNFa Medications
Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).
Measured: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).
Functional Disability Inventory
Functional Disability Inventory: (FDI); Walker \& Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker \& Greene, 1991).
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).
Measured: Day 1 (At time of Pediatric Intermed Interview)
Child Behaviour Checklist
Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Children's Depression Inventory
27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.
Measured: Administered at study entry
Multidimensional Anxiety Scale for Children
Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Pediatric Inventory for Parents- Difficulty Score
Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Family Inventory of Life Events and Changes
Family Inventory of Life Events and Changes (FILE): (McCubbin \& Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Family Inventory of Resources for Management
Family Inventory of Resources for Management (FIRM): (McCubbin \& Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.
Measured: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.
Measured: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).
Measured: Day 1 (Time of Study Participation)
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.
Measured: Day 1 (At time of Pediatric Intermed Interview)
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.
Measured: Day 1 (At time of Pediatric Intermed Interview)
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.
Measured: Day 1 (At time of Pediatric Intermed Interview)
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.
Measured: Day 1 (At time of Pediatric Intermed Interview)
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.
Measured: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis
Total Number of Hospital Services Involved in Child's Care.
Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.
Measured: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of Calls to IBD Nurse
Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview
Measured: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of Extra Appointments With the IBD Team
Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.
Measured: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of Visits to the Hospital Emergency Department
Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.
Measured: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of Inpatient Hospital Admissions
Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.
Measured: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startApr 2010
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Inflammatory Bowel DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Collaborators
- Janssen Inc.
- Responsible party
- Principal investigator, Janice S.Cohen, Children's Hospital of Eastern Ontario
- Investigators
- Janice S Cohen, Ph.D., Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781481
- Sponsor's protocol ID
- 09/32E
- Status last verified
- Jul 2016
- First submitted
- 23 Jan 2013
- Last updated
- 26 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Szigethy E, Craig AE, Iobst EA, Grand RJ, Keljo D, DeMaso D, Noll R. Profile of depression in adolescents with inflammatory bowel disease: implications for treatment. Inflamm Bowel Dis. 2009 Jan;15(1):69-74. doi: 10.1002/ibd.20693.
PubMed 18831071Benchimol EI, Guttmann A, Griffiths AM, Rabeneck L, Mack DR, Brill H, Howard J, Guan J, To T. Increasing incidence of paediatric inflammatory bowel disease in Ontario, Canada: evidence from health administrative data. Gut. 2009 Nov;58(11):1490-7. doi: 10.1136/gut.2009.188383. Epub 2009 Aug 2.
PubMed 19651626Astin JA, Soeken K, Sierpina VS, Clarridge BR. Barriers to the integration of psychosocial factors in medicine: results of a national survey of physicians. J Am Board Fam Med. 2006 Nov-Dec;19(6):557-65. doi: 10.3122/jabfm.19.6.557.
PubMed 17090789Fischer CJ, Stiefel FC, De Jonge P, Guex P, Troendle A, Bulliard C, Huyse FJ, Gaillard R, Ruiz J. Case complexity and clinical outcome in diabetes mellitus. A prospective study using the INTERMED. Diabetes Metab. 2000 Sep;26(4):295-302.
PubMed 11011222Stiefel FC, Huyse FJ, Sollner W, Slaets JP, Lyons JS, Latour CH, van der Wal N, de Jonge P. Operationalizing integrated care on a clinical level: the INTERMED project. Med Clin North Am. 2006 Jul;90(4):713-58. doi: 10.1016/j.mcna.2006.05.006.
PubMed 16843771Stiefel F, Zdrojewski C, Bel Hadj F, Boffa D, Dorogi Y, So A, Ruiz J, de Jonge P. Effects of a multifaceted psychiatric intervention targeted for the complex medically ill: a randomized controlled trial. Psychother Psychosom. 2008;77(4):247-56. doi: 10.1159/000129658. Epub 2008 Apr 28.
PubMed 18443391Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. doi: 10.1053/j.gastro.2007.05.029. Epub 2007 May 21.
PubMed 17681163Hyams J, Markowitz J, Otley A, Rosh J, Mack D, Bousvaros A, Kugathasan S, Pfefferkorn M, Tolia V, Evans J, Treem W, Wyllie R, Rothbaum R, del Rosario J, Katz A, Mezoff A, Oliva-Hemker M, Lerer T, Griffiths A; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Evaluation of the pediatric crohn disease activity index: a prospective multicenter experience. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):416-21. doi: 10.1097/01.mpg.0000183350.46795.42.
PubMed 16205508March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
PubMed 9100431Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
PubMed 1826329Otley AR, Griffiths AM, Hale S, Kugathasan S, Pfefferkorn M, Mezoff A, Rosh J, Tolia V, Markowitz J, Mack D, Oliva-Hemker M, Wyllie R, Rothbaum R, Bousvaros A, Del Rosario JF, Evans J, Blanchard W, Hyams J; Pediatric IBD Collaborative Research Group. Health-related quality of life in the first year after a diagnosis of pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2006 Aug;12(8):684-91. doi: 10.1097/00054725-200608000-00003.
PubMed 16917222Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.
PubMed 11259517Kovacs M. The Children's Depression, Inventory (CDI). Psychopharmacol Bull. 1985;21(4):995-8. No abstract available.
PubMed 4089116Bernstein CN, Wajda A, Svenson LW, MacKenzie A, Koehoorn M, Jackson M, Fedorak R, Israel D, Blanchard JF. The epidemiology of inflammatory bowel disease in Canada: a population-based study. Am J Gastroenterol. 2006 Jul;101(7):1559-68. doi: 10.1111/j.1572-0241.2006.00603.x.
PubMed 16863561Mackner LM, Crandall WV, Szigethy EM. Psychosocial functioning in pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2006 Mar;12(3):239-44. doi: 10.1097/01.MIB.0000217769.83142.c6.
PubMed 16534426
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Pediatric Intermed: A New Clinical Decision Making Tool for Proactive Evaluation of Psychosocial Stress in Children With Inflammatory Bowel Disease
- ClinicalTrials.gov ID
- NCT01781481
- Acronym / sponsor ID
- 09/32E
- Conditions
- Inflammatory Bowel Disease
- Keywords
- Psychosocial Stress and Adjustment, Pediatric Chronic Illness, Decision-support tool, Integrated Health Care, Case Complexity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Collaborators
- Janssen Inc.
- Study start
- Apr 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Posted 26 Jul 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators have recently developed a paediatric adaptation of the INTERMED tool to address the unique developmental and social contexts of children and youth. The Pediatric INTERMED adopts a life-chart methodology to structure and organize complex case material in time, colour-coding domains to facilitate identification of areas of high need and risk for each patient. The focus of the present study is to examine the characteristics and usefulness of the tool in identifying psychosocial stress in children/youth diagnosed with Inflammatory Bowel Disease (IBD), as well as identifying overall case complexity. Children and parents will participate in a semi-structured structured interview with a clinical nurse who will then rate the 34-PIM items. To examine the construct validity of each of the Pediatric INTERMED domains (biological, psychological, social, caregiver/family, health care system) participants will complete questionnaires assessing social and psychological functioning, parent and family stress, quality of life and adaptive functioning. Information about disease status, and health care utilization will be obtained from medical chart review. It is hypothesized that greater case complexity will be predictive of more complex disease course/treatment, poorer quality of life, and increased health care utilization.
Detailed description
Inflammatory Bowel Disease (Crohn's disease/ulcerative colitis) manifests itself in children and adolescents in up to 1/3 of those that will eventually develop these conditions. It is fast becoming an increasing problem with a 50% increase in Crohn's disease diagnosed in young children in the last decade. The patient's chronic symptoms can be both due to and result in increased child and family psychosocial stress. Similarly, treatments may add to psychosocial stress. Failure to address these psychosocial issues can lead to greater risk for poor treatment adherence, higher utilization of health care, and increased psychiatric co-morbidity. As such, improvement in health care providers' capacity to identify factors contributing to case complexity offers significant potential for improving outcomes.
Assessment of biological, psychological, social and health delivery of children's chronic illness has not been consistently integrated into the health care system. Physical and mental health services are often disconnected. Identifying those who would benefit from a mental health referral typically rests on the primary care physician or specialist and is often triggered by crises. There is also variability in physician education and comfort level in assessing psychosocial issues and especially in children with chronic illnesses in which symptoms of physical disease and mental health can overlap. Oftentimes this leaves the most responsible physician wanting for a simple assessment tool to try and determine who might be at risk and benefit from mental health intervention.
The adult INTERMED is a clinical decision-support tool that provides indicators of biological, psychological, social, heath care needs, as well as an overall index of case complexity. The tool is efficient to administer and has been successfully used by varied health care professionals in diverse medical settings to detect psychosocial needs, facilitate referral to effective services and improve health practices and outcomes. However, there is no comparable validated tool for use with children/youth.
The investigators have recently developed a pediatric adaptation of the adult INTERMED to address the unique developmental and social contexts of children and youth. A Delphi group of international experts in the field of pediatric chronic illness has reviewed the instrument to ensure clinical relevance, utility and communication clarity. Initial pilot data has demonstrated the Pediatric INTERMED has very good item inter-rater reliability. The focus of the current study is to examine the usefulness of this tool to identify biopsychosocial needs in IBD children/youth. Canada has a very high IBD incidence and prevalence. Given the facts that children with IBD face an unpredictable disease course, complex symptoms and difficult management regimens that can significantly impact their lives, it is not surprising that patients with this chronic incurable condition are highly vulnerable to mental health comorbidities. The development of this new tool will have significant importance if it proves to be useful in this population. The current study will examine a sizeable cohort of patients with regards to the relations between Pediatric INTERMED domains and other measures of children's disease, mood, behaviour, quality of life, family stress and strengths, and health services utilization. Both ulcerative colitis and Crohn's disease in children and youth lend themselves very well to this study because of the validated measures of disease severity that have been developed already.
Implementation of the novel Pediatric INTERMED n clinical practice will provide a new way to assist IBD Teams in screening their patients to be proactive in referral to mental health resources, and facilitate case management which targets patient needs. Clearly, clinicians are well aware that compliance, anxiety and depression will affect disease outcomes and too often these are only dealt with at times of crisis that has led to disease flare or reports that medicines are no longer effective. Use of this structured assessment tool begins to realize the potential of developing a truly integrated biopsychosocial approach to this chronic disease. The ease of use and objective nature of the tool will enhance communication among primary and tertiary providers and contribute to best practice approaches in the provision of integrated physical and mental health care. It will also assist in monitoring the impact of childhood chronic illness, identify factors linked to optimal health outcomes and inform program planning and resource allocations.
Study Design
Children/youth (ages of 8-17) followed in the IBD Clinic at the Children's Hospital of Eastern Ontario (CHEO) with confirmed diagnoses of IBD (Crohn's disease or ulcerative colitis) are eligible for the study. A clinical nurse will complete the Pediatric INTERMED for all study participants: based on information obtained from a review of the patients' hospital chart and a semi-structured interview conducted with the child/youth and primary caregivers), Following the Pediatric INTERMED interview, children/youth and parents participating in the project will complete a battery of self-report instruments to provide assessments of patients' social and psychological functioning, parent/family stresses, adjustment and resources. In addition, information will be obtained from the patients' charts about aspects of their diagnoses, treatment regimens, disease activity and complications, and health care utilization in the 3 months prior to their participation in the study.
Primary Hypotheses/Objectives and Statistical Rationale
- Demonstrate that the Pediatric INTERMED is a reliable tool for use in IBD children (good inter-rater reliability and internal consistency). 40 interviews with the clinical research nurse will be videotaped so that a second health care professional trained in the use of the PIM, can also complete the PIM tool, in order to examine inter-rater reliability. Agreement between raters will be measured by means of intraclass correlations. Items within each domain will be examined to confirm that they meet internal consistency criteria (Cronbach's Alpha of .80).
- Demonstrate that the Pediatric INTERMED domains successfully identify patient needs. Concurrent validity of the Pediatric INTERMED will be examined by looking at the Spearman rank, Pearson correlations, as appropriate, between each domain score and the measures hypothesized to be conceptually linked to the domain. To assess aspects of the Psychological Domain, the patients will complete the Children's Depression Inventory, the Multidimensional Anxiety Scale for Children and parents will complete the Child Behaviour Checklist (CBCL). Measures linked to the Social Domain of the PIM, include The Functional Disability Inventory, which taps the child's involvement in daily activities, and CBCL Competence Scores (Social, School, Activities), and the IMPACT-III, an IBD specific quality of life measure. To examine constructs linked to the Caregiver/Family Domain parents will complete the Pediatric Inventory for Parents, an index of childhood illness-related parenting stress, the Family Inventory of Life Events and Changes and the Family Inventory of Resources for Management. Disease/treatment and health care data gathered will be used to validate the Biological and Health System Domains.
- Demonstrate that Pediatric INTERMED Complexity score is predictive of increased health care utilization. A general linear approach will be used to study the relation of the Pediatric INTERMED to health service utilization. Multivariate models will also be tested including potential covariates such as disease severity, time since diagnosis.
Statistical Power Calculations
The CHEO GI clinic sees 40 to 60 new patients diagnosed with IBD per year. In 2007 the clinic actively followed 265 children with IBD. Once diagnosed children are followed on an ongoing basis. The frequency of follow-up appointments varies depending on the nature and course of a child's disease, but the children/youth are seen at minimum three times each year. In general, participation rates in studies of children/youth with chronic illness are typically in the vicinity of 80-90% or better and this figure is consistent with the experience of the CHEO IBD clinic in the recruitment of patients into various knowledge generation studies. The PIM involves 5 domains of information inclusive of various components. To achieve significance with the various domains the investigators estimated that a total of 140-150 children will need to be enrolled. This sample size is sufficient to ensure that there are a sufficient number of observations per variable to conduct multivariate analyses. Tabachnick and Fidell (2007) and others indicated that 4 is the absolute minimum number of observations per variable to conduct multivariate analyses. A subject size of 140-150 would be sufficient to provide 4 observations per variable. Further, the anticipated sample size is sufficient to conduct all proposed analyses. Further corrections for multiple testing will be applied on a per-analysis basis.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children and youth with IBD | – | –Children/youth (ages 8-17) with confirmed diagnoses of IBD. |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children between the ages of 8 and 17 who are followed in the CHEO GI Clinic and who have been diagnosed with an Inflammatory Bowel Disease (Crohn's Disease or Ulcerative Colitus). Once diagnosed, children are followed on an ongoing basis in the clinic for management of their chronic illness, with the frequency of follow-up appointments varying depending on the nature and course of a child's disease. Both parents of the subjects will be invited to participate in the study, although if only one parent is present only they will be included. If a child/youth is in foster placement, consent will be obtained from child protection officials to have the caregiver (s) most involved with the child/youth participate in the interview.
Key inclusion criteria (4 listed)
- diagnosis of IBD (Crohn's or Ulcerative Colitis)
- fluency in English or French
- between the ages of 8 and 17
- residing in the CHEO catchment area.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pediatric INTERMED- Complexity Index
Time frame: Time of Study Participation (Completion of Pediatric INTERMED tool)
34 item screening tool which identifies biological, psychological, social, caregiver/family and health service needs that contribute to case complexity. Each item is rated on a scale from 0-3 (0= no need to act; 1= watchful waiting or preventive intervention, 2=need for action, 3=need for immediate action). Minimum total score is 0 and Maximum score would be 102 (high complexity). Items on the Pediatric INTERMED are organized into 5 domains: Biological Domain (6 items). Minimum score is 0 and maximum score is 18 (high biological complexity). Psychological Domain (9 items). Minimum score is 0 and maximum score is 27 (high psychological complexity). Social Domain (7 items). Minimum score is 0 and maximum score is 21 (high social complexity). Family/Caregiver Domain (7 items). Minimum score is 0 and maximum score is 21 (high family/caregiver complexity). Health Services Domain (5 items). Minimum score is 0 and maximum score is 15 (high health service complexity).
Correlations Between Pediatric INTERMED Domain Scores
Time frame: Pediatric INTERMED scores at time of study participation
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED domain scores.
Pediatric INTERMED Items
Time frame: Day 1 (At time of Pediatric Intermed Interview)
Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items.
IBD Disease Severity
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
IBD Disease Severity Index categorizes patient's level of disease severity based on patient scores on the Pediatric Crohn's Disease Activity Index (PCDAI): (Hymans, Markowitz, Otley et al., 2005) and the Pediatric Ulcerative Colitis Activity Index (PUCAI) (Turner, Otley, Mack et al., 2007). Children's scores on either of these indices are used to categorize the severity of their disease as: inactive, mild, moderate, or severe.
Time Since IBD Diagnosis
Time frame: Data collected through chart review at time of Pediatric INTERMED interview.
Time since subject's initial IBD diagnosis. Data for each subject was obtained from chart review and was coded in "months since date of diagnosis", with a range from 1 - 131 months.
Disease Course and Treatment
Time frame: Data collected through chart review with respect to the period since diagnosis and Day 1 (date that patient's participation in Pediatric Intermed interview)
Number of hospitalizations since diagnosis (total number recorded in health record), number of surgeries since diagnosis (total number recorded in health record), number of courses of Prednisone (total number recorded in health record).
IBD Treatment With Immunomodulators or Anti-TNFa Medications
Time frame: Information from review of participants chart from time of diagnosis until study participation (date of Pediatric INTERMED interview).
Use of Immunomodulators (azathioprine or methotrexate). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2). Use of anti-Tumor Necrosis Factor alpha (TNFa) medications (infliximab or adalimumab). Coded for each participant as "yes" (Score of 1) or "no" (Score of 2).
Functional Disability Inventory
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Functional Disability Inventory: (FDI); Walker \& Greene, 1991). The FDI assesses illness related activity limitations in children and adolescents. The measure consists of 15 items that are scored by the child and parent as (0) "no trouble" to "(4) "impossible". The minimum score is 0 and the maximum score is 60, with higher scores indicating greater functional disability. The FDI has demonstrated good psychometric properties with test-retest reliability of .92 and .85 at the 3-month follow-up. Concurrent validity was provided by correlation (r=.52, p<.001) between the FDI and an objective index of disability (Walker \& Greene, 1991).
Impact-III: Quality of Life Questionnaire for Children With Inflammatory Bowel Disease.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
35-item self report measure for assessing quality of life in children with IBD (Otley, Griffiths, Hale et al., 2006). Items are rated on a 5-point Likert scale, with lower scores indicating poorer health related quality of life. Scores can range from 35-175. Four factor scores can be calculated: General Well-Being, Emotional Functioning, Social Functioning, Body Image, as well as a Total Quality of Life Score (Perrin, Kuhlthau, Chughtai et al., 2008).
Child Behaviour Checklist
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Child Behaviour Checklist: (CBCL: Achenbach 1991). The CBCL is used to evaluate behaviour problems and social competencies of children 6 to 18 years old. The measure is completed by parents or parent surrogates who base their ratings on the preceding 6 months. It is comprised of 120 problem items that factor into eight syndrome scales, which can be grouped into Internalizing, Externalizing and Total Problem Scales. Higher scores indicate greater level of emotional/behavioural difficulties. In the present study we utilized the following CBCL subscale scores: Internalizing, Externalizing, Social Competence, Activities Competence, Academic Competence. All scores reported are scaled to T Scores.
Children's Depression Inventory
Time frame: Administered at study entry
27 item self-report questionnaire used to measure depressive symptoms in children and youth (Kovacs 1992). Each item is rated on a 3-point Likert scale (0-2) with a minimum score of 0 and a maximum score of 54, with higher scores indicating more depressive symptoms. Raw scores were scaled to T-scores to control for age and gender differences.
Multidimensional Anxiety Scale for Children
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Multidimensional Anxiety Scale for Children: (MASC; March et a., 1997). The MASC is a pediatric self-report scale that measures symptoms of anxiety. It consists of 39 items assessing physical symptoms of anxiety, harm avoidance, social anxiety and separation/panic. Each item is answered using a four point Likert scale ranging from (0) "never true about me" to (3) "often true about me". Total scores can range from 0 to 117. The raw total score was scaled to T-Scores to control for age and sex differences.
Pediatric Inventory for Parents- Difficulty Score
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Pediatric Inventory for parents: (PIP; Streisand et al., 2001). The PIP is a 42-item self-report measure of parenting stress associated with caring for a medically ill child. It is the only published measure of parenting stress the specifically taps the experiences and stresses that parents face when caring for a medically ill child. The Difficulty Score - indicates parents' perception of the perceived difficulty of each stressor/item. Each item is scored on a 5 point Likert scale, with total scores ranging from 42 to 210, with higher scores indicating greater "perceived difficulty".
Family Inventory of Life Events and Changes
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Family Inventory of Life Events and Changes (FILE): (McCubbin \& Patterson, 1991). The FILE is a 71-item, yes/no instrument that assesses chronic and recent life stress in nine areas: intra-family strains, marital strains, pregnancy and childbearing strains, finance and business strains, work-family transitions and strains, illness and family care strains, losses, transition in and out, and family and legal violations. Family members indicate whether particular stressful events have occurred. The FILE has been found to have high reliability (Cronbach's alpha=.72), good test-retest reliability, internal consistency and evidence of construct validity. Scores can range from 0-71, with higher scores indicating greater family stress.
Family Inventory of Resources for Management
Time frame: Day 1 (Date of patient's participation in the Pediatric Intermed interview).
Family Inventory of Resources for Management (FIRM): (McCubbin \& Comeau 1991). The FIRM was developed to assess the family's repertoire of resources. The scale is comprised of 69 items, which are responded to using a 4-point Likert scale format (0-3). The scale has been found to have good internal reliability (r=.89, Cronbach's alpha), content and concurrent validity when used in normative sample of families with chronically ill children. The possible range for the total score is from 0-207, with higher scores indicating greater family resources for management. The Financial Well-Being subscale consists of 16 items, with potential scores ranging from 0-48, with higher scores indicating greater family financial resources.
Correlations Between Pediatric INTERMED Biological Domain Score/Items and Measures of Disease Severity, Disease Treatments and Functioning
Time frame: Pediatric INTERMED and Functioning at study participation and Disease related indices since IBD Diagnosis
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domains and items. Refer to Outcome Measure 4 for information pertaining to IBD Disease Severity. Refer to Outcome Measure 5 for information pertaining to Disease Treatments. Refer to Outcome Measure 8 for information pertaining to Functioning Disability Inventory. Refer to Outcome Measure 9 for information pertaining to the IMPACT III- Quality of Life Questionnaire.
Correlations Between Pediatric Psychological, Social and Family Domain Scores and Measures of Emotional, Behavioural, Social and Family Functioning.
Time frame: Day 1 (Time of Study Participation)
Relations between Pediatric INTERMED Psychological, Social and Family Domain scores and other validated measures of subjects' psychosocial adjustment, including depression (Children's Depression Inventory- Outcome Measure 11), anxiety (Multidimensional Anxiety Scale for Children-Outcome Measure 12), Behavioural Adjustment (Internalizing and Externalizing Scores on the CBCL- Outcome Measure 10), Competence (Social, Activities and School Competence Scores from the CBCL- Outcome Measure 10), and family functioning (Parenting Inventory for Parents- Outcome Measure 13, Family Inventory of Life Events-Outcome Measure 14, Family Inventory of Resources for Management- Outcome Measure 15), and IBD health-related quality of life (IMPACT III: Emotional Functioning and Social Interactions scales- Outcome Measure 9).
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total MASC Score Falls in the Clinical Range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat item when they scored in the clinical range on the Multidimensional Anxiety Scale for Children. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 12 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Multidimensional Anxiety Scale for Children were categorized as falling into the clinical range.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's Total Children's Depression Inventory (CDI) Score is in the Clinical Range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Children's Depression Inventory. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 11 for information pertaining to the Children's Depression Inventory. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 65 on the Children's Depression Inventory were categorized as falling into the clinical range.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Internalizing Score Falls in the Clinical Range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Internalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Internalizing Scale were categorized as falling into the clinical range.
Likelihood of Being Identified as Having a Mental Health Need on the Pediatric INTERMED Mental/Cognitive Threat Item When Subject's CBCL Externalizing Score is in the Clinical Range.
Time frame: Day 1 (At time of Pediatric Intermed Interview)
This outcome examined the increase in odds of a participant being identified as being rated as having a mental health need on the Pediatric INTERMED Mental Health/Cognitive Threat Item when they scored in the clinical range on the Child Behavior Checklist - Externalizing Problems Scale. Refer to Outcome Measure 1 for information pertaining to Pediatric INTERMED items. Refer to Outcome Measure 10 for information pertaining to the Child Behavior Checklist. Subjects were categorized into two groups based on their scores on Pediatric INTERMED Mental Health/Cognitive Threat ITEM: low psychological need (rating of 0 or 1) and high psychological need (rating of 2 or 3). Children with T scores above 63 on the Child Behavior Checklist Externalizing Scale were categorized as falling into the clinical range.
Correlations Between Pediatric Health System Domain Score/Items and Disease and Health Service Indicators
Time frame: Pediatric INTERMED and FIRM scores obtained at Study Entry and Disease and Health Care Indicators since IBD Diagnosis
Refer to Outcome Measure 1 and Outcome Measure 3 for information pertaining to Pediatric INTERMED domain scores and items. Refer to Outcome Measure 6 for information pertaining to Disease/Treatment Indicators. Refer to Outcome Measure 23 for information about the Number of Services involved in Child's Care, and to Outcome Measure 15 for information about the Family Inventory of Resources for Management.
Total Number of Hospital Services Involved in Child's Care.
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Measure of number of hospital services involved in each child's care during the three month period prior to the Pediatric INTERMED interview.
Number of Calls to IBD Nurse
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Total number of calls made by patient or parent to the IBD clinic nurse during the 3-month period prior to the Pediatric Intermed Interview
Number of Extra Appointments With the IBD Team
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of extra appointments (unscheduled, emergency) with the IBD Team during the 3 month period prior to the Pediatric INTERMED interview.
Number of Visits to the Hospital Emergency Department
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Number of times that the patient visited the hospital Emergency Department in the 3-month period prior to the Pediatric INTERMED interview.
Number of Inpatient Hospital Admissions
Time frame: Data collected through chart review with respect to the three month period prior to Day 1 (date of patient's participation in Pediatric Intermed interview)
Total number of times that the patient was admitted to hospital during the 3-month period prior to the Pediatric INTERMED Interview.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18831071Szigethy E, Craig AE, Iobst EA, Grand RJ, Keljo D, DeMaso D, Noll R. Profile of depression in adolescents with inflammatory bowel disease: implications for treatment. Inflamm Bowel Dis. 2009 Jan;15(1):69-74. doi: 10.1002/ibd.20693.
- Background: PubMed 19651626Benchimol EI, Guttmann A, Griffiths AM, Rabeneck L, Mack DR, Brill H, Howard J, Guan J, To T. Increasing incidence of paediatric inflammatory bowel disease in Ontario, Canada: evidence from health administrative data. Gut. 2009 Nov;58(11):1490-7. doi: 10.1136/gut.2009.188383. Epub 2009 Aug 2.
- Background: PubMed 17090789Astin JA, Soeken K, Sierpina VS, Clarridge BR. Barriers to the integration of psychosocial factors in medicine: results of a national survey of physicians. J Am Board Fam Med. 2006 Nov-Dec;19(6):557-65. doi: 10.3122/jabfm.19.6.557.
- Background: PubMed 11011222Fischer CJ, Stiefel FC, De Jonge P, Guex P, Troendle A, Bulliard C, Huyse FJ, Gaillard R, Ruiz J. Case complexity and clinical outcome in diabetes mellitus. A prospective study using the INTERMED. Diabetes Metab. 2000 Sep;26(4):295-302.
- Background: PubMed 16843771Stiefel FC, Huyse FJ, Sollner W, Slaets JP, Lyons JS, Latour CH, van der Wal N, de Jonge P. Operationalizing integrated care on a clinical level: the INTERMED project. Med Clin North Am. 2006 Jul;90(4):713-58. doi: 10.1016/j.mcna.2006.05.006.
- Background: PubMed 18443391Stiefel F, Zdrojewski C, Bel Hadj F, Boffa D, Dorogi Y, So A, Ruiz J, de Jonge P. Effects of a multifaceted psychiatric intervention targeted for the complex medically ill: a randomized controlled trial. Psychother Psychosom. 2008;77(4):247-56. doi: 10.1159/000129658. Epub 2008 Apr 28.
- Background: PubMed 17681163Turner D, Otley AR, Mack D, Hyams J, de Bruijne J, Uusoue K, Walters TD, Zachos M, Mamula P, Beaton DE, Steinhart AH, Griffiths AM. Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study. Gastroenterology. 2007 Aug;133(2):423-32. doi: 10.1053/j.gastro.2007.05.029. Epub 2007 May 21.
- Background: PubMed 16205508Hyams J, Markowitz J, Otley A, Rosh J, Mack D, Bousvaros A, Kugathasan S, Pfefferkorn M, Tolia V, Evans J, Treem W, Wyllie R, Rothbaum R, del Rosario J, Katz A, Mezoff A, Oliva-Hemker M, Lerer T, Griffiths A; Pediatric Inflammatory Bowel Disease Collaborative Research Group. Evaluation of the pediatric crohn disease activity index: a prospective multicenter experience. J Pediatr Gastroenterol Nutr. 2005 Oct;41(4):416-21. doi: 10.1097/01.mpg.0000183350.46795.42.
- Background: PubMed 9100431March JS, Parker JD, Sullivan K, Stallings P, Conners CK. The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. J Am Acad Child Adolesc Psychiatry. 1997 Apr;36(4):554-65. doi: 10.1097/00004583-199704000-00019.
- Background: PubMed 1826329Walker LS, Greene JW. The functional disability inventory: measuring a neglected dimension of child health status. J Pediatr Psychol. 1991 Feb;16(1):39-58. doi: 10.1093/jpepsy/16.1.39.
- Background: PubMed 16917222Otley AR, Griffiths AM, Hale S, Kugathasan S, Pfefferkorn M, Mezoff A, Rosh J, Tolia V, Markowitz J, Mack D, Oliva-Hemker M, Wyllie R, Rothbaum R, Bousvaros A, Del Rosario JF, Evans J, Blanchard W, Hyams J; Pediatric IBD Collaborative Research Group. Health-related quality of life in the first year after a diagnosis of pediatric inflammatory bowel disease. Inflamm Bowel Dis. 2006 Aug;12(8):684-91. doi: 10.1097/00054725-200608000-00003.
- Background: PubMed 11259517Streisand R, Braniecki S, Tercyak KP, Kazak AE. Childhood illness-related parenting stress: the pediatric inventory for parents. J Pediatr Psychol. 2001 Apr-May;26(3):155-62. doi: 10.1093/jpepsy/26.3.155.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janice S Cohen, Ph.D. principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Disease, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Jul 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pediatric INTERMED- Complexity Index (time frame: Time of Study Participation (Completion of Pediatric INTERMED tool)). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01781481, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2016.