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Completed

NCT Number: NCT05928182

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders Psychiatric Health

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

El Faro Treatment Intervention

Behavioral

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].

Primary outcomes

  1. Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS)

    Time frame: (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.

  2. Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Functional Impairment Scale (ADHD-FX)

    Time frame: (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.

  3. Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Attention Problem Scale of the Child Behavior Checklist (CBCL)

    Time frame: (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.

  4. Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Scale of the Child Behavior Checklist (CBCL)

    Time frame: (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.

  5. Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)

    Time frame: (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.

  6. Feasibility of adapted El Faro Treatment as measured by percentage of attrition

    Time frame: (8 weeks)

    Attrition of <25% will be set to establish feasibility

  7. Feasibility of adapted El Faro Treatment as measured by homework compliance

    Time frame: 8 weeks

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

    Time frame: 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)

  9. Acceptability of adapted El Faro Treatment as measured by caregiver perceptions

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jul 3, 2023
Registry last updated
Jul 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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