Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03499600|
Recruitment Status : Completed
First Posted : April 17, 2018
Last Update Posted : July 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Disruptive Behavior||Behavioral: Clinical Assessment and CFI Behavioral: Clinical Assessment||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||178 participants|
|Intervention Model:||Parallel Assignment|
|Intervention 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 (Participant, Outcomes Assessor)|
|Masking Description:||Coders assessing therapist fidelity to the CFI are kept unaware of the condition to which each participant is assigned. Participants will also be unaware of the condition to which they have been assigned.|
|Official Title:||Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||October 20, 2018|
|Actual Study Completion Date :||May 30, 2019|
Experimental: Clinical Assessment and CFI
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Behavioral: Clinical Assessment and CFI
CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
Active Comparator: Clinical Assessment Only
CA families will receive a standard Clinical Assessment during intake.
Behavioral: Clinical Assessment
CA families will participate their standard intake procedures.
- CFI Fidelity Instrument [ Time Frame: Post Intake Assessment (Week 0) ]The CFI Fidelity Instrument (CFI-FI; Aggarwal et al., 2014) assesses adherence and competence in the CA+CFI group and to ensure that patients in the CA condition are not receiving the CFI.
- CFI Clinician Questionnaire [ Time Frame: Post Intake Assessment (Week 0) ]The CFI Clinician Questionnaire is a 7-item measure developed designed to assess feasibility, acceptability and 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'.
- 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'.
- Cultural Competence Assessment [ Time Frame: Pre Intake Assessment (Week 0) ]Two subscales of the Cultural Competence Assessment (CCA; Schim et al., 2003) will be completed: the cultural competence behaviors scale and the cultural awareness and sensitivity scale, comprising 20 items.
- Therapy Attitudes Inventory [ Time Frame: Post Treatment (anticipated average: Week 14) ]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.
- Working Alliance Inventory-Short Form Revised [ Time Frame: Post Treatment (Anticipated average: Week 14) ]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'.
- Eyberg Child Behavior Inventory [ Time Frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) ]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 and Problem scales will be used to assess changes in child disruptive behavior.
- Everyday Stressors Index [ Time Frame: Post Intake Assessment (Week 0) ]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'.
- Multigroup Ethnic Identity Measure- Revised [ Time Frame: Post Intake Assessment (Week 0) ]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'. T
- Parental Attitudes Toward Psychological Services Inventory [ Time Frame: Post Intake Assessment (Week 0) ]Two subscales of the Parental Attitudes Toward Psychological Services Inventory (PATPSI; Turner, 2012) will be administered: help seeking attitudes scale and the stigmatization scale comprising 16 items. 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'.
- Parent quickness to mastery criteria [ Time Frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) ]Parent quickness to mastery criteria of the parenting skills used in Parent Child Interaction Therapy will be assessed.
- Everyday Discrimination Scale [ Time Frame: Post Intake Assessment (Week 0) ]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 1='never' to 6='almost every day'.
- Engagement [ Time Frame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14) ]Engagement will be measured for each family via: (a) initial session attendance, (b) dichotomous coding of whether they completed their full course of behavioral parent training or whether they dropped out prematurely (Dropout), (c) attendance rate (number of sessions attended over number of weeks in treatment), and (d) mean weekly homework completion across treatment (Homework Compliance)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03499600
|United States, Florida|
|University of Miami Mailman Center|
|Miami, Florida, United States, 33137|