Clinical Trials Directory

Trials / Completed

CompletedNCT03499600

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

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
89 (actual)
Sponsor
Florida International University · Academic / Other
Sex
All
Age
2 Years – 7 Years
Healthy volunteers
Not accepted

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

Interventions

TypeNameDescription
BEHAVIORALClinical Assessment and CFICA and CFI families will participate in the Cultural Formulation Interview prior to their standard intake.
BEHAVIORALClinical AssessmentCA families will participate their standard intake procedures.

Timeline

Start date
2017-08-01
Primary completion
2018-10-20
Completion
2019-05-30
First posted
2018-04-17
Last updated
2023-04-07
Results posted
2023-04-07

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03499600. Inclusion in this directory is not an endorsement.