Clinical trial NCT05928182: El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
Official title: El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Psychiatric Health
Keywords: Psychiatric Health
Children
ADHD
Latinx Community
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2023-07-03
Enrollment: 32
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will receive treatment and symptom severity will be measured pre and post-treatment.
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS)
timeFrame: (8 weeks)
measure: Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Functional Impairment Scale (ADHD-FX)
timeFrame: (8 weeks)
measure: Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Attention Problem Scale of the Child Behavior Checklist (CBCL)
timeFrame: (8 weeks)
measure: Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Scale of the Child Behavior Checklist (CBCL)
timeFrame: (8 weeks)
measure: Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the Parenting Sense of Competence Scale (PSOC)
timeFrame: (8 weeks)
measure: Feasibility of adapted El Faro Treatment as measured by percentage of attrition
timeFrame: (8 weeks)
measure: Feasibility of adapted El Faro Treatment as measured by homework compliance
timeFrame: 8 weeks
measure: Acceptability of adapted El Faro Treatment as measured by how satisfactory participants felt that the treatment was overall
timeFrame: 8 weeks
measure: Acceptability of adapted El Faro Treatment as measured by caregiver perceptions
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: John Mitchell, PhD
role: PRINCIPAL_INVESTIGATOR
References: