Clinical trial NCT05455203: 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
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Substance Use
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2022-07-13
Enrollment: 40
Sex: ALL
Minimum age (years): 11
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: PREVENTION

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.

Eligibility 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

Primary outcomes:
measure: Improving drug use communication between Black parents and children
timeFrame: 3 months
measure: Improving drug use communication between Black parents and children
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paterson
country: United States
facility: Oasis
state: New Jersey
Study officials:
affiliation: Yale University
name: Ijeoma Opara, PhD LMSW MPH
role: PRINCIPAL_INVESTIGATOR
References: