Substance UseNCT05455203
The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families
A study testing ADAPT-ITT in people with Substance Use, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 11 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- ADAPT-ITT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2026to Nov 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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
- Substance Use
- Being tested
- ADAPT-ITT
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADAPT-ITTBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ADAPT-ITT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.)
Measured: 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.)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2022
- Study startJan 2026 (estimated)
- Primary completionNov 2026 (estimated)
- Study completionNov 2026 (estimated)
Why it stopped: On hold until funding is secured.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Ijeoma Opara, PhD LMSW MPH, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05455203
- Sponsor's protocol ID
- 2000032674
- Other IDs
- R24DA051946
- Status last verified
- Apr 2025
- First submitted
- 7 Jul 2022
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development of a Brief Parent-Child Substance Use Educational Intervention for Black Families
- ClinicalTrials.gov ID
- NCT05455203
- Acronym / sponsor ID
- 2000032674
- Conditions
- Substance Use
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: On hold until funding is secured.
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2026 (estimated)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 13 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| ADAPT-ITT guided implementation and adaptation | Experimental | Behavioral: ADAPT-ITTADAPT-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. |
Who may qualify
- Ages
- 11 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADAPT-ITTADAPT-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. | Behavioural | ADAPT-ITT guided implementation and adaptation |
Primary outcome
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.)
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.)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ijeoma Opara, PhD LMSW MPH principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADAPT-ITT in people with Substance Use, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: paused, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improving drug use communication between Black parents and children (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.