History of Changes for Study: NCT05455203

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

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Study Record Versions

Version	Submitted Date	Changes
1	July 7, 2022	None (earliest Version on record)
2	October 5, 2022	Contacts/Locations and Study Status
3	January 11, 2023	Study Status
4	July 21, 2023	Study Status and Contacts/Locations

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Study Identification


Unique Protocol ID:	2000032674
Brief Title:	The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families
Official Title:	The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families
Secondary IDs:	R24DA051946 [U.S. NIH Grant/Contract]

Study Status


Record Verification:	July 2022
Overall Status:	Not yet recruiting
Study Start:	August 2022
Primary Completion:	December 2023 [Anticipated]
Study Completion:	December 2023 [Anticipated]

First Submitted:	July 7, 2022
First Submitted that Met QC Criteria:	July 7, 2022
First Posted:	July 13, 2022 [Actual]

Last Update Submitted that Met QC Criteria:	July 7, 2022
Last Update Posted:	July 13, 2022 [Actual]

Sponsor/Collaborators


Sponsor:	Yale University
Responsible Party:	Sponsor
Collaborators:	National Institute on Drug Abuse (NIDA)

Oversight


U.S. FDA-regulated Drug:	No
U.S. FDA-regulated Device:	No
Data Monitoring:	Yes

Study Description

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.

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.

Conditions


Conditions:	Substance Use
Keywords:

Study Design


Study Type:	Interventional
Primary Purpose:	Prevention
Study Phase:	Not Applicable
Interventional Study Model:	Single Group Assignment
	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.
Number of Arms:	1
Masking:	None (Open Label)
Allocation:	N/A
Enrollment:	40 [Anticipated]

Arms and Interventions

Arms

Assigned Interventions

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.

Behavioral: ADAPT-ITT

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.

Outcome Measures


Primary Outcome Measures:
1.	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.)
2.	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.)

Eligibility


Minimum Age:	11 Years
Maximum Age:	17 Years
Sex:	All
Gender Based:
Accepts Healthy Volunteers:	Yes
Criteria:	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

Contacts/Locations


Central Contact Person:	Ijeoma Opara, PhD, LMSW, MPH Email: ijeoma.opara@yale.edu
Central Contact Backup:	Cora Gabriel, MPH
Study Officials:	Ijeoma Opara, PhD, LMSW, MPH Principal Investigator Yale University
Locations:

IPDSharing


Plan to Share IPD:	No

References


Citations:
Links:
Available IPD/Information: