Medically Unexplained SymptomsNCT04277715
Parent Training for Youth With Chronic Symptoms
A study testing Parent training in people with Medically Unexplained Symptoms, run by Yale University at 1 site in United States.
Trial summary
The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Read more about this study
- Who is it for?
- Ages 10 to 17 years
- Conditions the study is for
- Medically Unexplained Symptoms
- What is being tested?
- Parent training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2021to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 10 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic Lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms
- Symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation
- Participants must be proficient or fluent in English
- Children must live with their participating parent(s) at least 50% of the time
Who cannot join
- Presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition
- Lifetime history of a psychotic disorder, bipolar disorder, Autism, or intellectual disability (Note: this criterion applies to child and parent(s))
- Presence of severe emotional or behavioral problems that require a more immediate treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Yale Child Study Center, Yale University School of Medicine
New Haven, Connecticut, 06511
About this study
Official title: Development of a Parent Training Intervention for Pediatric Patients With Medically Unexplained Symptoms
The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. The investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. The investigators also predict that this group will be acceptable and feasible for parents.
- Conditions
- Medically Unexplained Symptoms
- Being tested
- Parent training
- Medical subject headings
- Medically Unexplained Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent trainingBehavioural
Parents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms.
| Study group | Role | What they receive |
|---|---|---|
| Parent training | Experimental | Parents of participating children with chronic symptoms will receive the intervention in a virtual group format. Groups will last 90-minutes and run for 6-8 weeks. Groups will be co-led by a clinical psychologist and pediatric physician with expertise in child behavioral interventions and medically unexplained symptoms. Receives: Behavioral: Parent training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
The CSQ-8 is an 8-item self-report questionnaire that assesses satisfaction with (i.e., acceptability of) services received. Questions are rated on a response scale of 1("Quite dissatisfied") to 4("very satisfied"). An overall score is calculated by summing the respondent's score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction with/acceptability of treatment.
Measured: Post-treatment (6-8 weeks)
Secondary outcomes (14)
Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)
The FDI is a 15-item rating scale that assesses functional disability (i.e., physical and psycho-social functional impairment) in children and adolescents with chronic pain and related conditions. The FDI has a parent form and a child/adolescent form. Items are rated on a scale of 0 ("No trouble") to 4 ("Impossible"). Total scores range from 0-60, with higher scores indicating greater functional disability, categorized as No/Minimal (0-12), Moderate (13-29), and Severe (30) Disability.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)
The PedsQL is a modular, youth- and parent-report questionnaire assessing health-related quality of life in children and adolescents ages 2 to 18. The PedsQL Generic Core Scales contain 23-items about quality of life in physical, emotional, social, and school domains. Response options are on a five-point scale, ranging from 0 ("never") to 4 ("almost always"). Items are summed and higher scores indicate higher well-being.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)
The SIQR is used to measure physical function, overall impact of the syndrome, and symptom severity in youth (self- and parent-report). Respondents are asked to rate items on scales such as "no difficulty" to "very difficult" (physical function), "never" to "always" (impact of the syndrome), or "no pain" to "unbearable pain" (example of symptom severity). Total scores range from 0 (indicating no symptom impact) to 100 (extreme symptom impact). A 14% change in scores has been empirically determined to represent minimal clinically significant difference following treatment.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)
The CGI is a clinician-rated measure that assesses overall severity (CGI-S) and improvement (CGI-I) of child symptoms following treatment. CGI-S scores range from 1 ("normal, not at all ill") to 7 ("extremely ill"). CGI-I scores of 1 ("very much improved") or 2 ("much improved") indicate a positive treatment response; all other responses (3 "minimally improved" to 7 "very much worse") are considered negative responses to treatment.
Measured: Pre-treatment; Post-treatment
Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)
The SCARED is a 41-item self- and parent-report questionnaire assessing a range of anxiety symptoms. It is appropriate for children and adolescents ages 8-18. Items are rated on a 3-point scale ranging from 0 ("not true or hardly ever true") to 2 ("very true or often true"). Items are summed and total scores above 25 indicate the likely presence of an anxiety disorder.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Children's Depression Inventory (CDI-2; Kovacs, 2011).
The CDI-2 is a 28-item questionnaire assessing depressive symptoms. There are child- and parent- report versions. Respondents are asked to rate symptoms they have experienced (or observed, for parents) over the past two weeks. Each item contains 3 statements scored in order of increasing severity from 0 to 2. Higher total scores indicate greater depressive symptoms.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)
The FASA is a 13-item parent- and child-report scale that assesses family accommodation of a child's anxiety symptoms. The FASA asks respondents to rate the frequency of parental accommodation, the participation of parents in child's symptoms, and the changes that parents make in routines and schedules due to child's somatic symptoms. Items are rated on a 5-point response scale. Together, these items generate the total accommodation score, with higher scores indicating greater frequency and intensity of accommodation. One additional item assesses the degree of distress the accommodation causes the parents/child, and 4 additional items assess the short-term, negative consequences of not accommodating.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)
The PSI-4-SF is a 36-item parent-report scale that assesses three domains of parenting stress, including Parental Distress, Parent-Child Dysfunctional Interaction, and Difficult Child, which combine to form a Total Stress scale. Items are rated on a 5-point scale ranging from 1 ("strongly disagree") to 5 ("strongly agree"), with higher scores indicating more parenting stress.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)
The CCQ will be used to assess parent expectancies about treatment. To do so, it will be administered to all parents at the end of the first intervention session, after the treatment rationale has been presented. Parents will be asked to make ratings using a scale of 0 to 2 (None, Some, A lot) about: (1) how logical the treatment seems; (2) how confident they are the treatment will be successful, and (3) how confident they would be in recommending the treatment to a friend.
Measured: Following 1st group session (1 week)
Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)
The ICPACS is a 12-item parent-report measure that assesses the frequency of family accommodation of the child's pain in the past week. Items are rated on a scale ranging from 1 to 5. It includes three subscales: Modifications, Assistance, and Supportive Behaviors. An initial validation study indicated high internal consistency for the total scale (Harrison et al., 2016).
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)
The CRPBI is a 30-item scale used to assess current level of perceived parental behaviors, including acceptance and psychological control. Items are rated on a scale from 1 (Not like…) to 3 (A lot like … my mother). A higher score indicates higher perceived behaviors. There is also a parent-report version of this scale (PRPBI).
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)
The PSS is a 14-item scale that assesses perceived stress of life situations in adolescents and adults. Items are scored on a 5-point scale (0=never to 4=very often). Higher total scores indicate greater levels of perceived stress. The PSS has satisfactory reliability and has well-established validity in relation to physiological stress responses and anxiety and depressive disorders.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)
The CASI is an 18-item child self-report measure that assesses the extent to which children interpret anxiety symptoms as having negative physical, mental and social consequences. The scale has good construct validity, internal consistency and test-retest reliability (Silverman et al., 1991).
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)
The ARI-C/P is a parent- and child report measure that assesses frequency, duration, and threshold of child irritability symptoms over 6 months. The ARI-C/P contains 6 items that are rated along a 3-point scale (0 = not true, 1 = somewhat true, 2 = certainly true); total scores range from 0-12. A 7th item, not calculated in the total score, assesses level of general impairment caused by the irritability. The ARI-C/P has shown satisfactory internal consistency, discriminant validity, and is adequately described by a one-factor solution in confirmatory factor analyses.
Measured: Pre-treatment; Post-treatment; 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start5 Apr 2021
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Medically Unexplained SymptomsStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- The Wallace Foundation
- Responsible party
- Sponsor
- Investigators
- Wendy Silverman, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04277715
- Sponsor's protocol ID
- 2000027265
- Status last verified
- Sep 2023
- First submitted
- 17 Feb 2020
- Last updated
- 14 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Etkin RG, Winograd SM, Calhoun AJ, Silverman WK, Lebowitz ER, Shapiro ED. Pilot study of a parent-based intervention for functional somatic symptoms in children. J Pediatr Psychol. 2024 Dec 1;49(12):900-910. doi: 10.1093/jpepsy/jsae092.
PubMed 39468777
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Parent Training Intervention for Pediatric Patients With Medically Unexplained Symptoms
- ClinicalTrials.gov ID
- NCT04277715
- Acronym / sponsor ID
- 2000027265
- Conditions
- Medically Unexplained Symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- The Wallace Foundation
- Study start
- 5 Apr 2021 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 20 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the effects of a parent-only, group-based intervention intended to treat youth with chronic, unexplained medical symptoms such as (but not limited to) chronic fatigue, musculoskeletal pain, headache, and abdominal pain. Prior to and following the intervention, the child and parent(s) will be asked to complete several questionnaires about their well-being and functioning. The investigators predict that participation in this intervention will lead to change in relevant outcomes, including youth symptoms and functional impairment, and parenting stress and accommodation of symptoms. The investigators also predict that this group will be acceptable and feasible for parents.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parent training | Experimental | Behavioral: Parent trainingParents of participating children with chronic symptoms will receive the intervention in a virtual group format. Groups will last 90-minutes and run for 6-8 weeks. Groups will be co-led by a clinical psychologist and pediatric physician with expertise in child behavioral interventions and medically unexplained symptoms. |
Who may qualify
- Ages
- 10 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Presence of medically unexplained symptoms, including: fibromyalgia, chronic fatigue, chronic Lyme disease, irritable bowel syndrome, musculoskeletal pain, headache, abdominal pain and related bowel dysfunction, perceived cognitive impairment, or other nonspecific symptoms
- Symptoms must have been present for at least 3 months, associated with some degree of impairment (e.g., missing school), and not attributable to a known organic or medical disorder despite adequate evaluation
- Participants must be proficient or fluent in English
- Children must live with their participating parent(s) at least 50% of the time
Key exclusion criteria (3 listed)
- Presence of a serious medical condition by history, including chronic autoimmune or inflammatory condition
- Lifetime history of a psychotic disorder, bipolar disorder, Autism, or intellectual disability (Note: this criterion applies to child and parent(s))
- Presence of severe emotional or behavioral problems that require a more immediate treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent trainingParents will learn evidence-based techniques for increasing support and decreasing accommodation of children's chronic symptoms. | Behavioural | Parent training |
Primary outcome
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996)
Time frame: Post-treatment (6-8 weeks)
The CSQ-8 is an 8-item self-report questionnaire that assesses satisfaction with (i.e., acceptability of) services received. Questions are rated on a response scale of 1("Quite dissatisfied") to 4("very satisfied"). An overall score is calculated by summing the respondent's score for each scale item. Scores range from 8 to 32, with higher values indicating higher satisfaction with/acceptability of treatment.
14 secondary outcomes
Functional Disability Inventory (FDI; Kashikar-Zuck et al., 2011)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Pediatric Quality of Life Inventory (PedsQL; Varni, Seid, & Kurtin, 2001)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
The Symptom Impact Questionnaire-Revised (SIQR; Bennett, Friend, Jones, Ward, Han, & Ross, 2009)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Clinical Global Impression Scale (CGI; National Institutes of Mental Health, 1985)
Time frame: Pre-treatment; Post-treatment
Screen for Child Anxiety Related Emotional Disorders (SCARED; Birmaher, Khetarpal, Brent, Cully, Balach, Kaufman, & Neer, 1997)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Children's Depression Inventory (CDI-2; Kovacs, 2011).
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Family Accommodation Scale - Anxiety (FASA; Lebowitz et al., 2013; Lebowitz, Marin, & Silverman, 2019)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Parenting Stress Index, 4th Edition, Short-Form (PSI-4-SF; Abidin, 2012)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
The Client Credibility Questionnaire (CCQ; Borkovec & Nau, 1972)
Time frame: Following 1st group session (1 week)
Inventory of Parent Accommodations of Children's Symptoms (IPACS; Harrison, Peterson, Short, & Wetterneck, 2016)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Child's Report of Parental Behavior Inventory (CRPBI; Schludermann & Schludermann, 1988)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Perceived Stress Scale (PSS: Cohen, Kamarck, Mermelstein, 1983)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Child Anxiety Sensitivity Index (CASI; Silverman, Fleisig, Rabian, & Peterson, 1991)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Affective Reactivity Index-Child and Parent versions (ARI-C/P; Stringaris, Goodman, Ferdinando, Razdan, Muhrer, Leibenluft, & Brotman, 2012)
Time frame: Pre-treatment; Post-treatment; 3-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2023.
- Derived from this study: PubMed 39468777Etkin RG, Winograd SM, Calhoun AJ, Silverman WK, Lebowitz ER, Shapiro ED. Pilot study of a parent-based intervention for functional somatic symptoms in children. J Pediatr Psychol. 2024 Dec 1;49(12):900-910. doi: 10.1093/jpepsy/jsae092.
- 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.
Wendy Silverman, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent training in people with Medically Unexplained Symptoms, run by Yale University at 1 site in United States.
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 3 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 14 Sep 2023. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Client Satisfaction Questionnaire (CSQ-8; Attkisson & Greenfield, 1996) (time frame: Post-treatment (6-8 weeks)). 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 NCT04277715, which also lists 1 linked publication.
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 14 Sep 2023.