NCT05930886

Brief 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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 5, 2023

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 4, 2025

Completed
Last Updated

April 4, 2025

Status Verified

April 1, 2025

Enrollment Period

2.4 years

First QC Date

June 26, 2023

Last Update Submit

April 1, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Input and Feedback on Proposed Feasibility Study

    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

    Baseline

Study Arms (2)

Hispanic Community

15 adult parents/caregivers self-identified as Hispanic

Other: Focus Group

Black/African American Community

15 adult parents/caregivers self-identified as Black/African American

Other: Focus Group

Interventions

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.

Black/African American CommunityHispanic Community

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • Unwilling to be recorded

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Focus Groups

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Jeanette Johnstone, PhD

    Oregon Health and Science University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Johnstone, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 26, 2023

First Posted

July 5, 2023

Study Start

April 15, 2023

Primary Completion

August 30, 2025

Study Completion

October 4, 2025

Last Updated

April 4, 2025

Record last verified: 2025-04

Locations