The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families

NCT05455203 | Suspended DMC

• 2 other identifiers: 2000032674R24DA051946
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to adapt a racial-specific parent-child substance use education intervention for Black families in Paterson and East Orange, New Jersey which can promote family bonding, communication, and supervision, as well as acknowledging racial and ethnic specific norms, values, and pride. The adaptation of this intervention will be designed based on the needs of Black parents and their children and direct input from them as stakeholders.

Conditions

Substance Use

Outcome Measures

Primary Outcomes (2)

• Improving drug use communication between Black parents and children

  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

  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

Study Arms (1)

ADAPT-ITT guided implementation and adaptation

EXPERIMENTAL

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.

Behavioral: ADAPT-ITT

Interventions

ADAPT-ITT BEHAVIORAL

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.

ADAPT-ITT guided implementation and adaptation

Eligibility Criteria

• Age: 11 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Oasis

Paterson, New Jersey, 07501, United States

Location

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Ijeoma Opara, PhD LMSW MPH

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Black parents and youth between the ages of 11-17 years from (n=40) parent-child dyads will be recruited for this study. The study is a formative qualitative study design with the intention of using findings for the adaptation and evidence-based intervention.

Study Record Dates

• First Submitted: July 7, 2022
• First Posted: July 13, 2022
• Study Start: January 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)