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

NCT03499600 | Completed Results DMC

• 2 other identifiers: 106618R36MH116677-01
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

Disruptive Behavior

Keywords

Cultural assessment; Engagement; Diverse Populations

Outcome Measures

Primary Outcomes (3)

• CFI Clinician Questionnaire

  The CFI Clinician Questionnaire is a 4-item measure developed designed to assess 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'. Each item has a minimum score of 1 and a max of 5. Items include the extent to which conducting the CFI influences content and quality of information obtained in the intake, realtionship with the caregiver, treatment planning, and differential diagnosis. Higher scores indicate higher levels of clinical utility of the CFI. The measure was given only to the CA + CFI condition. This analysis was utilized to assess for initial utility of the CFI and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were descriptive and only examined for the experimental group.

  Post Intake Assessment (Week 0)

• Satisfaction With Intake Questionnaire

  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', with higher scores representing higher satisfaction. Each item has a minimum of 1 and maximum of 5. Items were not summed. Two items were analyzed separately for the main outcomes: linear regressions tested condition effects on caregiver and provider satisfaction, and the extent to which the provider understood the caregivers' values or what is important to them.

  Post Intake Assessment (Week 0)

• CFI Fidelity Instrument

  The CFI Fidelity Instrument assesses fidelity to the CFI (i.e. adherence and competence) in the CA+CFI group and potential cross-condition contamination in CA condition. Independent evaluators masked to condition, study design, and study hypotheses coded recordings of all assessments. This analysis was utilized to assess for feasibility of the pilot study and was mistakenly entered into the system as a primary outcome variable. This measure is not used to determine the effect of an experimental variable on participants in the study. Statistical analyses for this measure were only descriptive.

  Post Intake Assessment (Week 0)

Secondary Outcomes (9)

• Working Alliance Inventory-Short Form Revised

  Post Treatment (Anticipated average: Week 14)

• Treatment Response

  Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)

• Engagement

  Change from Baseline (Week 0) through post treatment

• Therapy Attitudes Inventory

  Post Treatment (anticipated average: Week 14)

• Eyberg Child Behavior Inventory

  Change from Baseline (Week 0) through post treatment (anticipated average: Week 14)

Study Arms (2)

Clinical Assessment and CFI

EXPERIMENTAL

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

Behavioral: Clinical Assessment and CFI

Clinical Assessment Only

ACTIVE COMPARATOR

CA families will receive a standard Clinical Assessment during intake.

Behavioral: Clinical Assessment

Interventions

Clinical Assessment and CFI BEHAVIORAL

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

Clinical Assessment and CFI

Clinical Assessment BEHAVIORAL

CA families will participate their standard intake procedures.

Clinical Assessment Only

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Parent is actively abusing illegal substances
• Child is younger than 2 years of age
• Child is older than 7 years of age

Sponsors & Collaborators

• Florida International University: lead
• University of Miami: collaborator
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

University of Miami Mailman Center

Miami, Florida, 33137, United States

Location

Related Publications (78)

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  PMID: 34905434 DERIVED

MeSH Terms

Conditions

Problem Behavior

Interventions

chemotactic factor inactivator

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Results Point of Contact

• Title: Dr. Amanda Sanchez
• Organization: George Mason University

asanch49@gmu.edu

703-993-1354

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 17, 2018
• Study Start: August 1, 2017
• Primary Completion: October 20, 2018
• Study Completion: May 30, 2019
• Last Updated: April 7, 2023
• Results First Posted: April 7, 2023

Record last verified: 2023-04

Locations

US (1)