ADHDNCT05928182
El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
A study testing El Faro Treatment Intervention in people with ADHD and Psychiatric Health, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- ADHD, Psychiatric Health
- What is being tested?
- El Faro Treatment Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Oct 2023to 30 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- ADHD, Psychiatric Health
- Being tested
- El Faro Treatment Intervention
- Keywords
- Psychiatric Health, Children, ADHD, Latinx Community
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
El Faro Treatment InterventionBehavioural
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].
| Study group | Role | What they receive |
|---|---|---|
| Treatment Participants | Experimental | Active treatment group participants Receives: Behavioral: El Faro Treatment Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: (8 weeks)
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.
Measured: (8 weeks)
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.
Measured: (8 weeks)
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.
Measured: (8 weeks)
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.
Measured: (8 weeks)
Feasibility of adapted El Faro Treatment as measured by percentage of attrition
Attrition of <25% will be set to establish feasibility
Measured: (8 weeks)
Feasibility of adapted El Faro Treatment as measured by homework compliance
Measured: 8 weeks
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)
Measured: 8 weeks
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).
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start10 Oct 2023
- Primary completion30 May 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will receive treatment and symptom severity will be measured pre and post-treatment.
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Mitchell, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928182
- Sponsor's protocol ID
- Pro00111427
- Status last verified
- Nov 2023
- First submitted
- 23 Jun 2023
- Last updated
- 30 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no IPD for this study.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- El Faro: Addressing Mental Health Inequities Among Latinx Children With ADHD in Durham
- ClinicalTrials.gov ID
- NCT05928182
- Acronym / sponsor ID
- Pro00111427
- Conditions
- ADHD, Psychiatric Health
- Keywords
- Psychiatric Health, Children, ADHD, Latinx Community
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 10 Oct 2023 (actual)
- Primary completion
- 30 May 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will receive treatment and symptom severity will be measured pre and post-treatment.
| Arm | Type | Receives |
|---|---|---|
| Treatment Participants | Experimental | Behavioral: El Faro Treatment InterventionActive treatment group participants |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| El Faro Treatment InterventionPre - 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]. | Behavioural | Treatment Participants |
Primary outcome
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.
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.
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.
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.
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.
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
Feasibility of adapted El Faro Treatment as measured by homework compliance
Time frame: 8 weeks
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)
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2024.
- Individual participant dataSharing planned: No. There is no IPD for this study.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Mitchell, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing El Faro Treatment Intervention in people with ADHD and Psychiatric Health, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Preliminary Treatment Efficacy of adapted EL Faro as measured by change in the ADHD Rating Scale (ADHD-RS) (time frame: (8 weeks)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2024.