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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05928182
• Other study ID #: Pro00111427
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2023
• Est. completion date: June 1, 2024

Study information

• Verified date: November 2023
• Source: Duke University
• Contact: Matthew Gibson
• Phone: 919-681-2521
• Email: matthew.gibson646[@]duke.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 1, 2024
• Est. primary completion date: June 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• ADHD
• Attention Deficit Disorder with Hyperactivity

Intervention

Behavioral:
• El Faro Treatment Intervention
Pre - Measures: complete Child Behavior Checklist (CBCL), ADHD module of the MINI International Neuropsychiatric Interview for Children and Adolescents (MINI) administered by study team, ADHD Rating Scale (ADHD-RS; parent and teacher ratings), ADHD Functional Impartment Scale (ADHD-FX), Parenting Sense of Competence (PSOC), demographic information, and medical history. [All rating scales are parent-report unless noted otherwise] Treatment: Complete an 8-week adapted El Faro treatment intervention with homework tasks. Post-Measures: CBCL, ADHD-RS (parent and teacher ratings), ADHD-FX, and PSOC. We will also acceptability and feasibility via measuring session attendance (rated by the therapist each session), homework completion (rated by the therapist each session), 7 treatment acceptability questions. [All rating scales are parent-report unless noted otherwise and administered at post-treatment visit unless noted otherwise].

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS)	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.	(8 weeks)
Primary	Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Functional Impairment Scale (ADHD-FX)	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.	(8 weeks)
Primary	Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Attention Problem Scale of the Child Behavior Checklist (CBCL)	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.	(8 weeks)
Primary	Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Scale of the Child Behavior Checklist (CBCL)	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.	(8 weeks)
Primary	Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)	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.	(8 weeks)
Primary	Feasibility of adapted El Faro Treatment as measured by percentage of attrition	Attrition of <25% will be set to establish feasibility	(8 weeks)
Primary	Feasibility of adapted El Faro Treatment as measured by homework compliance		8 weeks
Primary	Acceptability of adapted El Faro Treatment as measured by how satisfactory participants felt that the treatment was overall	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)	8 weeks
Primary	Acceptability of adapted El Faro Treatment as measured by caregiver perceptions	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).	8 weeks