Improving Satisfaction, Engagement and Outcomes Among Traditionally Underserved Children Through Cultural Formulation

NCT ID: NCT03499600

Last Updated: 2023-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 89 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2019-05-30

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.

Conditions

Disruptive Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Clinical Assessment and CFI

CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.

Group Type: EXPERIMENTAL

Clinical Assessment and CFI

Intervention Type: BEHAVIORAL

CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.

Clinical Assessment Only

CA families will receive a standard Clinical Assessment during intake.

Group Type: ACTIVE_COMPARATOR

Clinical Assessment

Intervention Type: BEHAVIORAL

CA families will participate their standard intake procedures.

Interventions

Clinical Assessment and CFI

CA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.

Intervention Type: BEHAVIORAL

Clinical Assessment

CA families will participate their standard intake procedures.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: collaborator

National Institute of Mental Health (NIMH)

NIH

Sponsor Role: collaborator

Florida International University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Miami Mailman Center

Miami, Florida, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

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Other Identifiers

R36MH116677-01

Identifier Type: NIH

Identifier Source: secondary_id

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106618

Identifier Type: -

Identifier Source: org_study_id