- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05455203
The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families
Study Overview
Detailed Description
The study is a formative qualitative study design with the intention of using findings for the adaptation and evidence-based intervention.
Study Approach: Using the ADAPT-ITT approach, we seek to first consult with Black families and stakeholders in cities that include a large population of Black people in Paterson and East Orange, New Jersey such as to understand their unique challenges in discussing substance use with their children while also seeking their guidance on the development of a racial specific substance use parent-child intervention. The investigator will use a proactive rather than a reactive approach to recruit study participants. A proactive approach brings project staff into direct contact with potential participants. This typically involves face-to-face contact with community leaders and organizations, as well as recruitment presentations and meetings in the community.
Aim 1: Collect qualitative data from Black parents and youth between the ages of 10-17 years from (n=20) parent-child dyads on the challenges, barriers, and facilitators to communicating about substance use. Recruitment will take place with partnership of community-based organizations and supportive family programs. Semi-structured interviews will be conducted with adolescents and their parents to solicit their perspectives on identifiable strategies that have worked to discuss substance use within their family, barriers and facilitators to effective prevention programs, and specific community and cultural norms regarding youth substance use. Interviews will be conducted separately where youth will be included in one focus group and interview and parents will be in a separate focus group and interview. This is done to allow for youth and parents to feel comfortable in sharing challenges pertaining to substance use prevention education.
Aim 2: Adapt a family and community-based substance use prevention intervention for Black youth and families in Paterson and East Orange, NJ. Using the ADAPT-ITT implementation framework, Phase 1 and 2 which include a family and community advisory board (consisting of three parent-child dyads and 3 community leaders) will be developed to guide the adaptation of the intervention. The proposed adapted intervention will build upon evidence-based parent-adolescent interventions such as the Strong African American Families-Teen (SAAF-T) and The Family Check Up.
Aim 2a: Phase 3 of ADAPT-ITT includes theater testing involving the family and community advisory board which will be responsible in reviewing the adapted interventions and providing feedback.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Jersey
-
Paterson, New Jersey, United States, 07501
- Oasis
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Identify as a Black/African American
- Children aged between 11-17
- Assent to being a part of the study
- Live in Paterson, New Jersey at the time of the study or Live in East Orange, NJ
- English as their first language.
Exclusion Criteria:
- Do not identify as Black/African American
- Do not assent to being a part of the study
- Does not live in Paterson, New Jersey or East Orange at the time of the study
- Does not read, speak or write in English
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ADAPT-ITT guided implementation and adaptation
ADAPT-ITT is an implementation science framework that guides the adaptation of evidence-based interventions (EBI) for specific settings or populations.
ADAPT-ITT will be used to adapt the target interventions in partnership with a Family and Community Advisory Board, consisting of parents, caregivers, and leaders of family-based organizations in New Jersey.
|
ADAPT-ITT is an implementation framework that guides adaptation of evidence-based interventions (EBI) for specific settings/populations.
It will be used to adapt target interventions with a Family and Community Advisory Board.
It has 8 phases: (1) Assess the risk profile of Black families in Paterson and East Orange, (2) Adopt or adapt an EBI, (3) Administer novel methods with families and children to facilitate the adaptation process, (4) Plan on what aspects of the EBI need to be adapted/how best to evaluate the adapted EBI, (5) Identify additional experts to assist in the adaptation process, (6) Integrate material from experts to adapt the EBI, (7) Train staff to implement the adapted intervention, and (8) Test the adapted intervention.
Given time and financial constraints, five phases will be completed at the end of the pilot study.
Qualitative data collected from individual dyad interviews will be used to inform the data.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Improving drug use communication between Black parents and children
Time Frame: 3 months
|
Assessed using parent-child drug use communication scales.
(This is a formative study that seeks to inform the intervention and the measures are being developed concurrently.)
|
3 months
|
|
Improving drug use communication between Black parents and children
Time Frame: 3 months
|
Assessed using child drug use knowledge scale.
(This is a formative study that seeks to inform the intervention and the measures are being developed concurrently.)
|
3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Ijeoma Opara, PhD LMSW MPH, Yale University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2000032674
- R24DA051946 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Substance Use
-
University of ArkansasNational Center for Advancing Translational Sciences (NCATS)RecruitingParenting | Substance Use Treatment | Perinatal Substance UseUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use | Substance Use Disorders | Cannabis Use | Alcohol Use, UnspecifiedUnited States
-
Indiana UniversityPatient-Centered Outcomes Research InstituteRecruitingAdolescent | Alcohol Use | Mild Alcohol Use Disorder | Mild Substance Use DisorderUnited States
-
Emory UniversityNational Institute on Drug Abuse (NIDA); Georgia Institute of Technology; CUNYCompletedSubstance-Related Disorders | Substance Abuse, Intravenous | Substance Use Disorders | Opioid Use | Substance Abuse | Opioid-use Disorder | Opioid Use Disorder, Severe | Substance WithdrawalUnited States
-
Woebot HealthNational Institute on Drug Abuse (NIDA); Stanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
University of California, San FranciscoTobacco Related Disease Research ProgramRecruitingTobacco Use Disorder | Substance Use Disorder (SUD)United States
-
Icahn School of Medicine at Mount SinaiNational Institute on Drug Abuse (NIDA)Active, not recruitingSubstance Use Disorder | Cocaine Use DisorderUnited States
-
Woebot HealthStanford UniversityCompletedSubstance Use Disorders | Alcohol Use Disorder (AUD)United States
-
Indiana UniversityNational Institute on Drug Abuse (NIDA)RecruitingSubstance Use Disorders | Nicotine Use DisorderUnited States
-
Medical University of South CarolinaNational Institute on Drug Abuse (NIDA)RecruitingTobacco Use | Substance Use DisordersUnited States
Clinical Trials on ADAPT-ITT
-
Boston UniversityNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedPrediabetesUnited States
-
University of MinnesotaArizona State UniversityCompleted
-
University of MinnesotaCompletedParentingUnited States
-
University of California, IrvineNational Institute of Mental Health (NIMH); Northwestern University; Mental Health...CompletedDepression, AnxietyUnited States
-
University of California, Los AngelesCenter for Adoption Support and EducationTerminatedPrevent Disorders in Children Adopted From Foster CareUnited States
-
Michigan State UniversityNational Center for Complementary and Integrative Health (NCCIH); Spectrum...CompletedAnxiety | Functional Abdominal Pain SyndromeUnited States
-
University of MinnesotaCompleted
-
Merck KGaA, Darmstadt, GermanyCompleted
-
Kaiser PermanenteWithdrawnDepression | AnxietyUnited States
-
East Carolina UniversityAkron Children's Hospital; Palliative Care Research Cooperative GroupCompleted