Back to resultsEl Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
Primary Purpose
ADHD, Psychiatric Health
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
El Faro Treatment Intervention
Sponsored by
About this trial
This is an interventional treatment trial for ADHD focused on measuring Psychiatric Health, Children, ADHD, Latinx Community
Eligibility Criteria
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)
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Treatment Participants
Arm Description
Active treatment group participants
Outcomes
Primary Outcome Measures
Preliminary efficacy of adapted El Faro Treatment as measured by change in the Behavior Rating Inventory of Executive Function (BRIEF-2)
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.
Preliminary efficacy of adapted El Faro Treatment as measured by change in the Conners Comprehensive Behavior Rating Scale (CBRS)
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.
Feasibility of adapted El Faro Treatment as measured by percentage of attrition
Attrition of <25% will be set to establish feasibility.
Feasibility of adapted El Faro Treatment as measured by homework compliance
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).
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).
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05928182
Brief Title
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
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
June 1, 2024 (Anticipated)
Study Completion Date
June 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ADHD, Psychiatric Health
Keywords
Psychiatric Health, Children, ADHD, Latinx Community
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All participants will receive treatment and symptom severity will be measured pre and post-treatment.
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Treatment Participants
Arm Type
Experimental
Arm Description
Active treatment group participants
Intervention Type
Behavioral
Intervention Name(s)
El Faro Treatment Intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Preliminary efficacy of adapted El Faro Treatment as measured by change in the Behavior Rating Inventory of Executive Function (BRIEF-2)
Description
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.
Time Frame
Pre-treatment to post-treatment (8 weeks)
Title
Preliminary efficacy of adapted El Faro Treatment as measured by change in the Conners Comprehensive Behavior Rating Scale (CBRS)
Description
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.
Time Frame
Pre-treatment to post-treatment (8 weeks)
Title
Feasibility of adapted El Faro Treatment as measured by percentage of attrition
Description
Attrition of <25% will be set to establish feasibility.
Time Frame
8 weeks
Title
Feasibility of adapted El Faro Treatment as measured by homework compliance
Time Frame
8 weeks
Title
Acceptability of adapted El Faro Treatment as measured by how satisfactory participants felt that the treatment was overall
Description
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).
Time Frame
8 weeks
Title
Acceptability of adapted El Faro Treatment as measured by caregiver perceptions
Description
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).
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Matthew Gibson
Phone
919-681-2521
Email
matthew.gibson646@duke.edu
First Name & Middle Initial & Last Name or Official Title & Degree
John Mitchell, PhD
Phone
919-681-2521
Email
matthew.gibson646@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Mitchell, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There is no IPD for this study.
Learn more about this trial
El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
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