Attention Deficit/Hyperactivity DisorderNCT05930886
Focus Groups in Ethnically and Racially Diverse Families
An observational study of Attention Deficit/Hyperactivity Disorder and Emotional Dysfunction, run by Oregon Health and Science University at 1 site in United States.
Trial summary
Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder, Emotional Dysfunction, Irritable Mood
- What is being tested?
- Focus Group
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2023to 4 Oct 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Community samples of Portland, Oregon individuals who self-identify as Hispanic/Latino/a for one focus group and Black/African American for another.
Who may be able to join
- Adult parents/caregivers self-identified as Black or Hispanic/Latino
- With a family member 6-18 years old with suspected ADHD and/or emotional dysregulation, or provide care for, or teach someone who meets these criteria
- Who have sought or are interested in treatment
- Willing to discuss child's mental health care needs and provide feedback regarding feasibility study
- Able to attend focus groups in person
- Able to communicate in English or Spanish
- Agree to focus group session audio recording
Who cannot join
- Unwilling to be recorded
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Oregon Health & Science University
Portland, Oregon, 97239
Jeanette Johnstone, PhD, 503-494-3700, jojeanet@ohsu.edu
About this study
Official title: Focus Groups to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation
Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities.
Read the detailed description
Focus group purpose is to understand parents' priorities regarding their child's mental health, and facilitators or barriers to research participation generally, with inquiry about CIH intervention use, and the multinutrient feasibility study specifically. Researchers will engage Black and Hispanic families in focus groups to discuss mental health priorities related to their children, and real or perceived barriers to engagement in research studies. The feedback will inform the final design and recruitment for the multinutrient feasibility study in Black and Hispanic populations. One group will comprise individuals who self-identify as Hispanic, another, as Black, in order to create space to hear perspectives that may differ between broadly defined groups.
- Being tested
- Focus Group
- 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.
Focus GroupOther
Black or Hispanic/Latino parents, caregivers or family members of children with ADHD symptoms and/or emotional dysregulation, will discuss: (1) impact of child's mental health, treatments, care received; (2) perceived and actual barriers to future study participation, including discussion about acceptability of bio-specimen collection methods for urine and blood. Each group will comprise individuals who self-identify as Hispanic/Latino, Black, or mixed race. Groups are anticipated to comprise individuals who identify with one or the the other race/ethnicity in order to create space to hear perspectives that may differ between these broadly defined groups.
| Study group | Role | What they receive |
|---|---|---|
| Hispanic Community | 15 adult parents/caregivers self-identified as Hispanic Receives: Other: Focus Group | |
| Black/African American Community | 15 adult parents/caregivers self-identified as Black/African American Receives: Other: Focus Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Input and Feedback on Proposed Feasibility Study
Purpose is understanding
- Parents' priorities regarding their child's mental health
- Facilitators or barriers to research participation generally
- Parent input on planned study specifically
- Specific recommendations for modifying the future feasibility study design
- Previous CIH intervention use
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2023
- Study start15 Apr 2023
- Primary completion30 Aug 2025 (estimated)
- Study completion4 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science 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
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeanette Johnstone, Oregon Health and Science University
- Investigators
- Jeanette Johnstone, PhD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05930886
- Sponsor's protocol ID
- 00024335
- Status last verified
- Apr 2025
- First submitted
- 26 Jun 2023
- Last updated
- 4 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Focus Groups to Optimize Research Methodology in a Multinutrient Study of Racially and Ethnically Diverse Children With ADHD and Emotional Dysregulation
- ClinicalTrials.gov ID
- NCT05930886
- Acronym / sponsor ID
- 00024335
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 30 Aug 2025 (estimated)
- Study completion
- 4 Oct 2025 (estimated)
- First posted
- 5 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.
Focus groups to identify treatment needs and barriers to participation in the planned multinutrient study among racially and ethnically diverse (Black and Hispanic) communities.
Detailed description
Focus group purpose is to understand parents' priorities regarding their child's mental health, and facilitators or barriers to research participation generally, with inquiry about CIH intervention use, and the multinutrient feasibility study specifically. Researchers will engage Black and Hispanic families in focus groups to discuss mental health priorities related to their children, and real or perceived barriers to engagement in research studies. The feedback will inform the final design and recruitment for the multinutrient feasibility study in Black and Hispanic populations. One group will comprise individuals who self-identify as Hispanic, another, as Black, in order to create space to hear perspectives that may differ between broadly defined groups.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hispanic Community | – | Other: Focus Group15 adult parents/caregivers self-identified as Hispanic |
| Black/African American Community | – | Other: Focus Group15 adult parents/caregivers self-identified as Black/African American |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Community samples of Portland, Oregon individuals who self-identify as Hispanic/Latino/a for one focus group and Black/African American for another.
Key inclusion criteria (7 listed)
- Adult parents/caregivers self-identified as Black or Hispanic/Latino
- With a family member 6-18 years old with suspected ADHD and/or emotional dysregulation, or provide care for, or teach someone who meets these criteria
- Who have sought or are interested in treatment
- Willing to discuss child's mental health care needs and provide feedback regarding feasibility study
- Able to attend focus groups in person
Key exclusion criteria (1 listed)
- Unwilling to be recorded
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 |
|---|---|---|
| Focus GroupBlack or Hispanic/Latino parents, caregivers or family members of children with ADHD symptoms and/or emotional dysregulation, will discuss: (1) impact of child's mental health, treatments, care received; (2) perceived and actual barriers to future study participation, including discussion about acceptability of bio-specimen collection methods for urine and blood. Each group will comprise individuals who self-identify as Hispanic/Latino, Black, or mixed race. Groups are anticipated to comprise individuals who identify with one or the the other race/ethnicity in order to create space to hear perspectives that may differ between these broadly defined groups. | Other | Black/African American Community, Hispanic Community |
Primary outcome
Input and Feedback on Proposed Feasibility Study
Time frame: Baseline
Purpose is understanding 1. Parents' priorities regarding their child's mental health 2. Facilitators or barriers to research participation generally 3. Parent input on planned study specifically 4. Specific recommendations for modifying the future feasibility study design 5. Previous CIH intervention use
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2025.
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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.
Jeanette Johnstone, PhD principal investigator
Oregon Health and Science University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Attention Deficit/Hyperactivity Disorder and Emotional Dysfunction, run by Oregon Health and Science 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 7 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 4 Apr 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jeanette Johnstone, PhD (503-494-3700, jojeanet@ohsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Input and Feedback on Proposed Feasibility Study (time frame: Baseline). 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 4 Apr 2025.