Disruptive Behavior Clinical Trial
Official title:
Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Verified date | April 2023 |
Source | Florida International University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 89 |
Est. completion date | May 30, 2019 |
Est. primary completion date | October 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 7 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - Parent is actively abusing illegal substances - Child is younger than 2 years of age - Child is older than 7 years of age |
Country | Name | City | State |
---|---|---|---|
United States | University of Miami Mailman Center | Miami | Florida |
Lead Sponsor | Collaborator |
---|---|
Florida International University | National Institute of Mental Health (NIMH), University of Miami |
United States,
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* Note: There are 77 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. |
Post Intake Assessment (Week 0) | |
Primary | 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. |
Post Intake Assessment (Week 0) | |
Primary | 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. |
Post Intake Assessment (Week 0) | |
Secondary | 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. | Post Treatment (Anticipated average: Week 14) | |
Secondary | 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. |
Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) | |
Secondary | 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) | Change from Baseline (Week 0) through post treatment | |
Secondary | 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. | Post Treatment (anticipated average: Week 14) | |
Secondary | 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. |
Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) | |
Secondary | 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. |
Post Intake Assessment (Week 0) | |
Secondary | 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. |
Post Intake Assessment (Week 0) | |
Secondary | 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. |
Post Intake Assessment (Week 0) | |
Secondary | 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. |
Post Intake Assessment (Week 0) |
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