Disruptive BehaviorNCT03499600
Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation
A study testing Clinical Assessment and CFI and Clinical Assessment in people with Disruptive Behavior, run by Florida International University at 1 site in United States.
Trial summary
The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health… Read more about this study
- Who is it for?
- Ages 2 to 7 years
- Conditions the study is for
- Disruptive Behavior
- What is being tested?
- Clinical Assessment and CFI and Clinical Assessment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 89 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 30 May 2019
- Phase
- Interventional
- 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 2 to 7 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with elevated behavior problems
- Child is between ages 2-7 years (inclusive)
- Family seeking services at one of the University of Miami PCIT-Community Connect Centers
Who cannot join
- Parent is actively abusing illegal substances
- Child is younger than 2 years of age
- Child is older than 7 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Mailman Center
Miami, Florida, 33137
About this study
Official title: Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health problems (i.e., the Cultural Formulation Interview; CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early child behavior problems. Additional analyses will explore whether traditional barriers (e.g., stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction, engagement and treatment outcomes.
Read the detailed description
This project is leveraging a pilot randomized design to evaluate initial feasibility and preliminarily examine whether augmenting assessment procedures for child behavior problems with the CFI improves satisfaction with assessment procedures and treatment, parent engagement in subsequent behavior parent training, and ultimately clinical child outcomes. Exploratory analyses will further consider whether traditional barriers to care moderate outcomes. The study is being conducted within a large South Florida mental health network serving predominately low-income minority families obtaining parent training for early child behavior problems. Participating families will be randomized at baseline to receive either the standard diagnostic and clinical assessment (CA) or CA+CFI.
Specifically, the investigators are interested in assessing study feasibility. Feasibility of recruitment and randomization, study retention, and condition integrity will be monitored. Additionally, clinician reports of CFI feasibility, acceptability and clinical utility will be examined. An additional main outcome will be initial satisfaction directly after the interview. It is hypothesized that families in the CA+CFI group will report higher levels of initial satisfaction than the CA group. A secondary goal is to assess preliminary effects of administering the CFI on treatment satisfaction, engagement and clinical child outcomes. Parents and therapists will report on their satisfaction with treatment. Engagement outcomes will be measured via: (a) initial session attendance, (b) drop out rate (c) session attendance rate, (d) homework completion rate, and (e) therapeutic alliance. Clinical outcomes will be measured via parent ratings of child behavior problems and parent time to skill mastery. It is hypothesized that CA+CFI families will demonstrate improved satisfaction, engagement and clinical outcomes relative to CA families. Further exploratory analyses will examine individual differences in effects related to traditional barriers to care. Exploratory analyses will examine stigma, ethnic identity, and daily stress as moderators of the effects of CFI administration on satisfaction, engagement and clinical outcomes. It is hypothesized that CFI effects will be particularly strong for families who experience greater traditional barriers to care.
- Conditions
- Disruptive Behavior
- Being tested
- Clinical Assessment and CFI, Clinical Assessment
- Keywords
- Cultural assessment, Engagement, Diverse Populations
- Medical subject headings
- Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Assessment and CFIBehavioural
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
Clinical AssessmentBehavioural
CA families will participate their standard intake procedures.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Assessment and CFI | Experimental | CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake. Receives: Behavioral: Clinical Assessment and CFI |
| Clinical Assessment Only | Active comparator | CA families will receive a standard Clinical Assessment during intake. Receives: Behavioral: Clinical Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
CFI Clinician Questionnaire
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition.
This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
Measured: Post Intake Assessment (Week 0)
Satisfaction With Intake Questionnaire
The Satisfaction with Intake Questionnaire is a 7-item measure developed for use in the current study to assess parent and clinician satisfaction with their intake assessment. This measure assesses how well the patient/clinician felt the clinician understood the family's problems, cultural background, how their culture may influence their problem, and how much the parent trusts the clinician. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed.
Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
Measured: Post Intake Assessment (Week 0)
CFI Fidelity Instrument
The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments.
This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.
Measured: Post Intake Assessment (Week 0)
Secondary outcomes (9)
Working Alliance Inventory-Short Form Revised
The WAI-Short Form Revised (WAI-SR; Hatcher \& Gillaspy, 2006) is a 12-item clinician- and patient-report measure of therapeutic alliance that assesses (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 5-point Likert style scale ranging from 1='never' to 5='always'. Scores on each sub scale are summed to create a total score. Total scores range from 12-60 with higher scores representing higher therapeutic alliance.
Measured: Post Treatment (Anticipated average: Week 14)
Treatment Response
Treatment response reflected traditional PCIT graduation criteria: caregiver skill acquisition as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range.
Families were classified as Treatment Responders in accordance with formal PCIT graduation criteria, that is: (a) caregivers demonstrated skill acquisition, as coded against specific criteria in both phases of treatment; and (b) child behavior problems dropped into the subclinical range - i.e., Eyberg Child Behavior Inventory (ECBI) falls below 114).
Participants were coded as either treatment responders=1, or treatment non-responders=0.
Measured: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Engagement
Engagement will be measured for each family via: (a) dichotomous coding of initial session attendance (yes=1, no=0), (b) dichotomous coding of whether they completed the first treatment module (yes=1, no=0), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)
Measured: Change from Baseline (Week 0) through post treatment
Therapy Attitudes Inventory
The Therapy Attitudes Inventory (TAI; Brestan et al., 2000) is a 10-item parent-report of satisfaction with treatment including change in child behavior problems and parenting skills on a likert style scale from 1="nothing"-5="very many useful techniques". Items are summed to create a total score. Minimum value is 10 and maximum value is 50. Higher scores represent higher satisfaction with treatment.
Measured: Post Treatment (anticipated average: Week 14)
Eyberg Child Behavior Inventory
The Eyberg Child Behavior Inventory (ECBI; Eyberg \& Pincus, 1999) is a 36-item parent-report measure of disruptive behavior problems in children as young as 2 years that has shown strong psychometrics. The intensity score is summed to form a total score and ranges from 36 to 252 with higher numbers representing more severe behavior problems.
The difference in ECBI score between baseline and treatment completion was measured.
Measured: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Everyday Stressors Index
The Everyday Stressors Index (ESI Hall, 1983) is a 20-item measure that assesses daily stressors experienced by economically disadvantaged parents with young children. Items are rated on a Likert-style scale ranging from 1='not at bothered' to 4='bothered a great deal' with higher scores indicating higher levels of stress. The minimum value=20, and maximum value=80
This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Measured: Post Intake Assessment (Week 0)
Multigroup Ethnic Identity Measure- Revised
The Multigroup Ethnic Identity Measure- Revised (MEIM-R; Phinney \& Ong, 2007) is a 6-item measure that assesses exploration of and commitment to one's ethnic group. Items are rated on a 5-point Likert-style scale from 1='strongly disagree' to 6='strongly agree', with higher scores indicating stronger ethnic identity.
This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Measured: Post Intake Assessment (Week 0)
Parental Attitudes Toward Psychological Services Inventory
Two subscales of the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help seeking attitudes scale (8 items) and the stigmatization scale (8 items) comprising 16 items total. The PATPSI assesses caregivers' attitudes toward outpatient mental health services. Items are rated on a 5-point Likert-style scale from 0='strongly disagree' to 5='strongly agree'.
Item responses are summed to form a stigma total scale (minimum value=0 and maximum value=40) and a help seeking total scale (minimum value=0 and maximum value=40) with higher scores representing more mental health related stigma and more positive attitudes toward mental health services.
This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Measured: Post Intake Assessment (Week 0)
Everyday Discrimination Scale
The Everyday Discrimination Scale (EDS; Williams et al., 1997) is a 9-item measure that assesses aspects of interpersonal discrimination or unfair treatment in their day-to-day life. Items are rated on a Likert-style scale ranging from 0='never' to 5='almost every day', with higher scores indicating more experiences of discrimination. The minimum score is 0 and maximum score is 45. Scores were averaged to create a mean discrimination score which could range from 0 to 5.
This is a single time point assessment and is therefore not an outcome variable. There was an error when registering in clinical trials.
Measured: Post Intake Assessment (Week 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2018
- Study start1 Aug 2017
- Primary completion20 Oct 2018
- Study completion30 May 2019
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 (78)Papers the sponsor has linked to this study.
- Other trials for Disruptive BehaviorStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial in which participants are randomly assigned to either receive a diagnostic and clinical assessment plus the cultural formulation interview (CA and CFI) or the diagnostic and clinical assessment (CA).
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 89 participants (actual)
Sponsor and investigators
- Lead sponsor
- Florida International University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Miami, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03499600
- Sponsor's protocol ID
- 106618
- Other IDs
- R36MH116677-01
- Status last verified
- Apr 2023
- First submitted
- 9 Apr 2018
- Last updated
- 7 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data
Publications
Aggarwal NK. Cultural formulations in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):306-9. No abstract available.
PubMed 20410723Aggarwal NK, Desilva R, Nicasio AV, Boiler M, Lewis-Fernandez R. Does the Cultural Formulation Interview for the fifth revision of the diagnostic and statistical manual of mental disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site. Ethn Health. 2015;20(1):1-28. doi: 10.1080/13557858.2013.857762. Epub 2013 Nov 15.
PubMed 25372242Aggarwal NK, Glass A, Tirado A, Boiler M, Nicasio A, Alegria M, Wall M, Lewis-Fernandez R. The development of the DSM-5 Cultural Formulation Interview-Fidelity Instrument (CFI-FI): a pilot study. J Health Care Poor Underserved. 2014 Aug;25(3):1397-417. doi: 10.1353/hpu.2014.0132.
PubMed 25130248Aggarwal NK, Lam P, Castillo EG, Weiss MG, Diaz E, Alarcon RD, van Dijk R, Rohlof H, Ndetei DM, Scalco M, Aguilar-Gaxiola S, Bassiri K, Deshpande S, Groen S, Jadhav S, Kirmayer LJ, Paralikar V, Westermeyer J, Santos F, Vega-Dienstmaier J, Anez L, Boiler M, Nicasio AV, Lewis-Fernandez R. How Do Clinicians Prefer Cultural Competence Training? Findings from the DSM-5 Cultural Formulation Interview Field Trial. Acad Psychiatry. 2016 Aug;40(4):584-91. doi: 10.1007/s40596-015-0429-3. Epub 2015 Oct 8.
PubMed 26449983Aggarwal NK, Nicasio AV, DeSilva R, Boiler M, Lewis-Fernandez R. Barriers to implementing the DSM-5 cultural formulation interview: a qualitative study. Cult Med Psychiatry. 2013 Sep;37(3):505-33. doi: 10.1007/s11013-013-9325-z.
PubMed 23836098Akincigil A, Olfson M, Siegel M, Zurlo KA, Walkup JT, Crystal S. Racial and ethnic disparities in depression care in community-dwelling elderly in the United States. Am J Public Health. 2012 Feb;102(2):319-28. doi: 10.2105/AJPH.2011.300349. Epub 2011 Dec 15.
PubMed 22390446Alegría, M., Green, J. G., McLaughlin, K. A., & Loder, S. (2015). Disparities in child and adolescent mental health and mental health services in the US.
Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001.
PubMed 21056345American Psychiatric Association (2000). Diagnostic and statisticalmanual of mental disorders (4th ed., text rev.). Washington, DC: Author.
American Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
Barkley RA, Shelton TL, Crosswait C, Moorehouse M, Fletcher K, Barrett S, Jenkins L, Metevia L. Multi-method psycho-educational intervention for preschool children with disruptive behavior: preliminary results at post-treatment. J Child Psychol Psychiatry. 2000 Mar;41(3):319-32.
PubMed 10784079Blanco C, Patel SR, Liu L, Jiang H, Lewis-Fernandez R, Schmidt AB, Liebowitz MR, Olfson M. National trends in ethnic disparities in mental health care. Med Care. 2007 Nov;45(11):1012-9. doi: 10.1097/MLR.0b013e3180ca95d3.
PubMed 18049340Briggs-Gowan MJ, Carter AS, Skuban EM, Horwitz SM. Prevalence of social-emotional and behavioral problems in a community sample of 1- and 2-year-old children. J Am Acad Child Adolesc Psychiatry. 2001 Jul;40(7):811-9. doi: 10.1097/00004583-200107000-00016.
PubMed 11437020Burke JD, Waldman I, Lahey BB. Predictive validity of childhood oppositional defiant disorder and conduct disorder: implications for the DSM-V. J Abnorm Psychol. 2010 Nov;119(4):739-51. doi: 10.1037/a0019708.
PubMed 20853919Burnett-Zeigler I, Lee Y, Bohnert KM. Ethnic Identity, Acculturation, and 12-Month Psychiatric Service Utilization Among Black and Hispanic Adults in the U.S. J Behav Health Serv Res. 2018 Jan;45(1):13-30. doi: 10.1007/s11414-017-9557-8.
PubMed 28492979
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
- ClinicalTrials.gov ID
- NCT03499600
- Acronym / sponsor ID
- 106618
- Conditions
- Disruptive Behavior
- Keywords
- Cultural assessment, Engagement, Diverse Populations
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 89 participants (actual)
- Lead sponsor
- Florida International UniversityUniversity, hospital or other
- Collaborators
- University of Miami, National Institute of Mental Health (NIMH)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 20 Oct 2018 (actual)
- Study completion
- 30 May 2019 (actual)
- First posted
- 17 Apr 2018 (actual)
- Results
- Posted 7 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The project at the center of this proposal will leverage a pilot randomized design to examine initial feasibility and preliminary effects of augmenting usual mental health evaluation procedures with a structured person-centered assessment tool that specifically considers the cultural context of patient mental health problems (i.e., the Cultural Formulation Interview; CFI) on parent satisfaction, engagement and clinical child outcomes in the treatment of early child behavior problems. Additional analyses will explore whether traditional barriers (e.g., stigma, ethnic identity, and daily stress) moderate the effects of the CFI on satisfaction, engagement and treatment outcomes.
Detailed description
This project is leveraging a pilot randomized design to evaluate initial feasibility and preliminarily examine whether augmenting assessment procedures for child behavior problems with the CFI improves satisfaction with assessment procedures and treatment, parent engagement in subsequent behavior parent training, and ultimately clinical child outcomes. Exploratory analyses will further consider whether traditional barriers to care moderate outcomes. The study is being conducted within a large South Florida mental health network serving predominately low-income minority families obtaining parent training for early child behavior problems. Participating families will be randomized at baseline to receive either the standard diagnostic and clinical assessment (CA) or CA+CFI.
Specifically, the investigators are interested in assessing study feasibility. Feasibility of recruitment and randomization, study retention, and condition integrity will be monitored. Additionally, clinician reports of CFI feasibility, acceptability and clinical utility will be examined. An additional main outcome will be initial satisfaction directly after the interview. It is hypothesized that families in the CA+CFI group will report higher levels of initial satisfaction than the CA group. A secondary goal is to assess preliminary effects of administering the CFI on treatment satisfaction, engagement and clinical child outcomes. Parents and therapists will report on their satisfaction with treatment. Engagement outcomes will be measured via: (a) initial session attendance, (b) drop out rate (c) session attendance rate, (d) homework completion rate, and (e) therapeutic alliance. Clinical outcomes will be measured via parent ratings of child behavior problems and parent time to skill mastery. It is hypothesized that CA+CFI families will demonstrate improved satisfaction, engagement and clinical outcomes relative to CA families. Further exploratory analyses will examine individual differences in effects related to traditional barriers to care. Exploratory analyses will examine stigma, ethnic identity, and daily stress as moderators of the effects of CFI administration on satisfaction, engagement and clinical outcomes. It is hypothesized that CFI effects will be particularly strong for families who experience greater traditional barriers to care.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial in which participants are randomly assigned to either receive a diagnostic and clinical assessment plus the cultural formulation interview (CA and CFI) or the diagnostic and clinical assessment (CA).
| Arm | Type | Receives |
|---|---|---|
| Clinical Assessment and CFI | Experimental | Behavioral: Clinical Assessment and CFICA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake. |
| Clinical Assessment Only | Active comparator | Behavioral: Clinical AssessmentCA families will receive a standard Clinical Assessment during intake. |
Who may qualify
- Ages
- 2 to 7 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Child with elevated behavior problems
- Child is between ages 2-7 years (inclusive)
- Family seeking services at one of the University of Miami PCIT-Community Connect Centers
Key exclusion criteria (3 listed)
- Parent is actively abusing illegal substances
- Child is younger than 2 years of age
- Child is older than 7 years of age
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 |
|---|---|---|
| Clinical Assessment and CFICA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake. | Behavioural | Clinical Assessment and CFI |
| Clinical AssessmentCA families will participate their standard intake procedures. | Behavioural | Clinical Assessment Only |
Primary outcome
CFI Clinician Questionnaire
Time frame: Post Intake Assessment (Week 0)
The CFI Clinician Questionnaire is a 4-item measure developed designed to assess clinical utility of the CFI. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.
Satisfaction With Intake Questionnaire
Time frame: Post Intake Assessment (Week 0)
The Satisfaction with Intake Questionnaire is a 7-item measure developed for use in the current study to assess parent and clinician satisfaction with their intake assessment. This measure assesses how well the patient/clinician felt the clinician understood the family's problems, cultural background, how their culture may influence their problem, and how much the parent trusts the clinician. Items are rated on a 5-point Likert style scale ranging from 1='not at all' to 5='very much', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed. Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.
CFI Fidelity Instrument
Time frame: Post Intake Assessment (Week 0)
The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments. This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.
9 secondary outcomes
Working Alliance Inventory-Short Form Revised
Time frame: Post Treatment (Anticipated average: Week 14)
Treatment Response
Time frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Engagement
Time frame: Change from Baseline (Week 0) through post treatment
Therapy Attitudes Inventory
Time frame: Post Treatment (anticipated average: Week 14)
Eyberg Child Behavior Inventory
Time frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
Everyday Stressors Index
Time frame: Post Intake Assessment (Week 0)
Multigroup Ethnic Identity Measure- Revised
Time frame: Post Intake Assessment (Week 0)
Parental Attitudes Toward Psychological Services Inventory
Time frame: Post Intake Assessment (Week 0)
Everyday Discrimination Scale
Time frame: Post Intake Assessment (Week 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 20410723Aggarwal NK. Cultural formulations in child and adolescent psychiatry. J Am Acad Child Adolesc Psychiatry. 2010 Apr;49(4):306-9. No abstract available.
- Background: PubMed 25372242Aggarwal NK, Desilva R, Nicasio AV, Boiler M, Lewis-Fernandez R. Does the Cultural Formulation Interview for the fifth revision of the diagnostic and statistical manual of mental disorders (DSM-5) affect medical communication? A qualitative exploratory study from the New York site. Ethn Health. 2015;20(1):1-28. doi: 10.1080/13557858.2013.857762. Epub 2013 Nov 15.
- Background: PubMed 25130248Aggarwal NK, Glass A, Tirado A, Boiler M, Nicasio A, Alegria M, Wall M, Lewis-Fernandez R. The development of the DSM-5 Cultural Formulation Interview-Fidelity Instrument (CFI-FI): a pilot study. J Health Care Poor Underserved. 2014 Aug;25(3):1397-417. doi: 10.1353/hpu.2014.0132.
- Background: PubMed 26449983Aggarwal NK, Lam P, Castillo EG, Weiss MG, Diaz E, Alarcon RD, van Dijk R, Rohlof H, Ndetei DM, Scalco M, Aguilar-Gaxiola S, Bassiri K, Deshpande S, Groen S, Jadhav S, Kirmayer LJ, Paralikar V, Westermeyer J, Santos F, Vega-Dienstmaier J, Anez L, Boiler M, Nicasio AV, Lewis-Fernandez R. How Do Clinicians Prefer Cultural Competence Training? Findings from the DSM-5 Cultural Formulation Interview Field Trial. Acad Psychiatry. 2016 Aug;40(4):584-91. doi: 10.1007/s40596-015-0429-3. Epub 2015 Oct 8.
- Background: PubMed 23836098Aggarwal NK, Nicasio AV, DeSilva R, Boiler M, Lewis-Fernandez R. Barriers to implementing the DSM-5 cultural formulation interview: a qualitative study. Cult Med Psychiatry. 2013 Sep;37(3):505-33. doi: 10.1007/s11013-013-9325-z.
- Background: PubMed 22390446Akincigil A, Olfson M, Siegel M, Zurlo KA, Walkup JT, Crystal S. Racial and ethnic disparities in depression care in community-dwelling elderly in the United States. Am J Public Health. 2012 Feb;102(2):319-28. doi: 10.2105/AJPH.2011.300349. Epub 2011 Dec 15.
- BackgroundAlegría, M., Green, J. G., McLaughlin, K. A., & Loder, S. (2015). Disparities in child and adolescent mental health and mental health services in the US.
- Background: PubMed 21056345Alegria M, Vallas M, Pumariega AJ. Racial and ethnic disparities in pediatric mental health. Child Adolesc Psychiatr Clin N Am. 2010 Oct;19(4):759-74. doi: 10.1016/j.chc.2010.07.001.
- BackgroundAmerican Psychiatric Association (2000). Diagnostic and statisticalmanual of mental disorders (4th ed., text rev.). Washington, DC: Author.
- BackgroundAmerican Psychiatric Association (2013). Diagnostic and statistical manual of mental disorders (5th ed.). Arlington, VA: American Psychiatric Publishing.
- Background: PubMed 10784079Barkley RA, Shelton TL, Crosswait C, Moorehouse M, Fletcher K, Barrett S, Jenkins L, Metevia L. Multi-method psycho-educational intervention for preschool children with disruptive behavior: preliminary results at post-treatment. J Child Psychol Psychiatry. 2000 Mar;41(3):319-32.
- Background: PubMed 18049340Blanco C, Patel SR, Liu L, Jiang H, Lewis-Fernandez R, Schmidt AB, Liebowitz MR, Olfson M. National trends in ethnic disparities in mental health care. Med Care. 2007 Nov;45(11):1012-9. doi: 10.1097/MLR.0b013e3180ca95d3.
- Individual participant dataSharing planned: Undecided. We will use a controlled access approach, using a robust system to review requests and provide secure access to de-identified data
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Disruptive Behavior Disorders, Conduct Disorder
Not yet recruiting
QAIAx - SGI/SI Smart Health Cities: Microcity Enclave Program (Quantum SI/AGI Agency a/k/a AI City Hall Project - UPSTO App Nos. 64/074,526, 64/063,557, 64/105,164, 63/903,181, 63/729,428, 64/125,360; USPTO EO 9424 Assignment ID: 2101042 / ARN: REEL/FRAME: 76481/0026 - OUSD-R&E, Department of War)
Asperger's Disorder, Asperger Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Assessment and CFI and Clinical Assessment in people with Disruptive Behavior, run by Florida International 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 3 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 7 Apr 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?
Yes. Results are posted in the registry (first posted 7 Apr 2023). 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?
CFI Clinician Questionnaire (time frame: Post Intake Assessment (Week 0)). The study lists 3 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 NCT03499600, which also lists 78 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 7 Apr 2023.