Clinical trial NCT03499600: Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Official title: Improving Satisfaction, Engagement and Clinical Outcomes Among Traditionally Underserved Children Through Cultural Formulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior
Keywords: Cultural assessment
Engagement
Diverse Populations
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: University of Miami
name: National Institute of Mental Health (NIMH)
First posted: 2018-04-17
Enrollment: 89
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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).
Primary purpose: OTHER

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: CFI Clinician Questionnaire
timeFrame: Post Intake Assessment (Week 0)
measure: Satisfaction With Intake Questionnaire
timeFrame: Post Intake Assessment (Week 0)
measure: CFI Fidelity Instrument
timeFrame: Post Intake Assessment (Week 0)
Secondary outcomes:
measure: Working Alliance Inventory-Short Form Revised
timeFrame: Post Treatment (Anticipated average: Week 14)
measure: Treatment Response
timeFrame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
measure: Engagement
timeFrame: Change from Baseline (Week 0) through post treatment
measure: Therapy Attitudes Inventory
timeFrame: Post Treatment (anticipated average: Week 14)
measure: Eyberg Child Behavior Inventory
timeFrame: Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)
measure: Everyday Stressors Index
timeFrame: Post Intake Assessment (Week 0)
measure: Multigroup Ethnic Identity Measure- Revised
timeFrame: Post Intake Assessment (Week 0)
measure: Parental Attitudes Toward Psychological Services Inventory
timeFrame: Post Intake Assessment (Week 0)
measure: Everyday Discrimination Scale
timeFrame: Post Intake Assessment (Week 0)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Mailman Center
state: Florida
Study officials:
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