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

Florida International University (FIU) logo

Florida International University (FIU)

Status

Completed

Conditions

Disruptive Behavior

Treatments

Behavioral: Clinical Assessment and CFI
Behavioral: Clinical Assessment

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT03499600
R36MH116677-01 (U.S. NIH Grant/Contract)
106618

Details and patient eligibility

About

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.

Full 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.

Enrollment

89 patients

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

89 participants in 2 patient groups

Clinical Assessment and CFI
Experimental group
Description:
CA and CFI families will receive the Cultural Formulation Interview prior to their standard Clinical Assessment during their intake.
Treatment:
Behavioral: Clinical Assessment and CFI
Clinical Assessment Only
Active Comparator group
Description:
CA families will receive a standard Clinical Assessment during intake.
Treatment:
Behavioral: Clinical Assessment

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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