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

Not Applicable

Completed

• Conditions: Psychiatric Health; ADHD
• Interventions: Behavioral: El Faro Treatment Intervention

• Registration Number: NCT05928182
• Lead Sponsor: Duke University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-06-23
• Study First Submitted QC: 2023-06-23
• Study First Posted: 2023-07-03
• Study Start: 2023-10-10
• Status Verified: 2023-11
• Primary Completion: 2024-05-30
• Study Completion: 2024-05-30
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• Child is between the ages of 6 to 12 years
• Child has received a previous diagnosis of ADHD in the community based on caregiver report
• ADHD Rating Scale (parent rating scale of ADHD symptoms) symptom severity score of 24 or higher
• Child meets DSM-5 criteria for ADHD (any presentation) based on the MINI
• 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
• Caregiver self-identify as Latinx

Exclusion Criteria

• Caregiver's child has previous diagnosis of Autism, Schizophrenia, or Bipolar Disorder in the community per caregiver report 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)
• Other concerns besides ADHD that would interfere with study participation according to the study team.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment Participants	El Faro Treatment Intervention	Active treatment group participants

Primary Outcome Measures

Name	Time	Method
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)	(8 weeks)	A 16-item questionnaire with a 6-point Likert scale ranging from Strongly Disagree (1) - Strongly Agree (6). A total score range of 16 - 96. A higher score indicates a better outcome.
Feasibility of adapted El Faro Treatment as measured by homework compliance	8 weeks
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Functional Impairment Scale (ADHD-FX)	(8 weeks)	A 32-item questionnaire with 4-point Likert scale ranging from Not at All (0) - A lot (3). With a total score range of 0 - 96. A lower score indicates better outcome.
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)
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS)	(8 weeks)	An 18-item questionnaire with a 4-point Likert scale ranging from Never or Rarely (0) - Very Often (3). With a total score range of 0 -54. A lower score indicated a better outcome.
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Scale of the Child Behavior Checklist (CBCL)	(8 weeks)	A 7-item parent report questionnaire with a 3-point Likert Scale ranging from Not True (0) to Very True or Often True (2). A total score range of 0-14. Lower scores indicate a better outcome.
Feasibility of adapted El Faro Treatment as measured by percentage of attrition	(8 weeks)	Attrition of \<25% will be set to establish feasibility
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Attention Problem Scale of the Child Behavior Checklist (CBCL)	(8 weeks)	A 10-item parent report questionnaire with a 3-point Likert Scale ranging from Not True (0) to Very True or Often True (2). A total score range of 0-20. Lower scores indicate better outcomes.
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).

Trial Locations

Locations (1)

Duke University; 🇺🇸 Durham, North Carolina, United States