El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham

Sponsor
Duke University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05928182
Collaborator
(none)
30
1
10

Study Details

Study Description

Brief Summary

Study team members from El Futuro in Durham, North Carolina have created an intervention called El Faro. El Faro helps Latinx families of children with ADHD understand and cope with the stress and difficulties presented by the disorder. We propose to develop a community-engaged research partnership between El Futuro and the Duke ADHD Program that aims to pilot-test an adapted El Faro treatment.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: El Faro Treatment Intervention
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
All participants will receive treatment and symptom severity will be measured pre and post-treatment.All participants will receive treatment and symptom severity will be measured pre and post-treatment.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Treatment Participants

Active treatment group participants

Behavioral: El Faro Treatment Intervention
Pre - Measures: complete pre-treatment Kiddie Schedule for Affective Disorders and Schizophrenia (K-SADS), Behavior Rating Inventory of Executive Function (BRIEF-2), Conners 3, demographic information. Treatment: Complete an 8-week adapted El Faro treatment intervention with homework tasks. Post-Measures: Behavior Rating Inventory of Executive Function (BRIEF-2), Conners 3, acceptability and feasibility questionnaires.

Outcome Measures

Primary Outcome Measures

  1. Preliminary efficacy of adapted El Faro Treatment as measured by change in the Behavior Rating Inventory of Executive Function (BRIEF-2) [Pre-treatment to post-treatment (8 weeks)]

    The BRIEF-2 is a parent-completed questionnaire that provides data on the extent to which executive dysfunction impairs a child in his or her natural settings. T-scores are used to interpret the level of executive functioning. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). T-scores provide information about an individual's scores relative to the scores of respondents in the standardization sample. For all BRIEF2 clinical scales and indexes, T-scores from 60 to 64 are considered mildly elevated, and T-scores from 65 to 69 are considered potentially clinically elevated. T-scores at or above 70 are considered clinically elevated.

  2. Preliminary efficacy of adapted El Faro Treatment as measured by change in the Conners Comprehensive Behavior Rating Scale (CBRS) [Pre-treatment to post-treatment (8 weeks)]

    The Conners CBRS is a questionnaire that focuses on behavioral, social, and academic issues in children aged 6-18 years old. T-scores are used to interpret the level of executive functioning. These scores are linear transformations of the raw scale scores (M = 50, SD = 10). T-scores provide information about an individual's scores relative to the scores of respondents in the standardization sample. A T-score of more than 60 can indicate that the child may have an issue such as ADHD, a T-score greater than 60 but under 70 may indicate moderately severe issues, a T-score above 70 may be a sign that the behavioral, academic, or emotional problems are severe.

  3. Feasibility of adapted El Faro Treatment as measured by percentage of attrition [8 weeks]

    Attrition of <25% will be set to establish feasibility.

  4. Feasibility of adapted El Faro Treatment as measured by homework compliance [8 weeks]

  5. Acceptability of adapted El Faro Treatment as measured by how satisfactory participants felt that the treatment was overall [8 weeks]

    Acceptability will be based on how satisfactory participants felt that the treatment was overall (ranging from 1-7 with 7 indicating the highest rating of treatment satisfaction).

  6. Acceptability of adapted El Faro Treatment as measured by caregiver perceptions [8 weeks]

    Caregiver perceptions about the extent of ADHD psychoeducation they received, how the content was relevant to their experiences, whether the techniques introduced were understandable, if they were confident about regularly using the techniques taught, and if they would recommend El Faro to other families of children with ADHD (on a scale ranging from 1 = not at all to 4 = extremely).

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 12 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Child is between the ages of 6 to 12 years

  • Child meets DSM-5 criteria for ADHD (any presentation)

  • Generally healthy (i.e., no major medical problems that will interfere with study participation

  • Caregiver's willingness to keep any current psychiatric medication regimen for child diagnosed with ADHD constant throughout the study duration

  • Caregiver age 18 years and older

Exclusion Criteria:
  • Caregiver's child meets DSM-5 diagnostic criteria for psychosis, bipolar disorder, or other psychiatric disorder that is primary to ADHD or may interfere with study involvement

  • Caregiver unable to attend all El Faro sessions

  • Plan to initiate new ADHD treatment for identified child with ADHD during study participation (previously established ADHD treatments are allowable)

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Duke University

Investigators

  • Principal Investigator: John Mitchell, PhD, Duke University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT05928182
Other Study ID Numbers:
  • Pro00111427
First Posted:
Jul 3, 2023
Last Update Posted:
Jul 3, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 3, 2023