Substance UseBT PilotNCT06594835
Test of the Better Together Intervention
A study testing Better Together and Youth In the Media (YM) in people with Substance Use, run by Johns Hopkins Bloomberg School of Public Health at 1 site in United States.
Trial summary
Better Together (BT) is a novel, culturally relevant library-based intervention designed to prevent substance use among Black youth (ages 11-13) affected by household challenges (i.e., parental substance use, parental incarceration, and parental mental health challenges). Read more about this study
- Who is it for?
- Ages 11 to 13 years
- Conditions the study is for
- Substance Use
- What is being tested?
- Better Together and Youth In the Media (YM)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 1 May 2024
- 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 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- To be eligible, participants had to be between 11 and 13 years old,
- identify as Black or African American,
- have been exposed to one or more household challenges (i.e., parental substance use, incarceration or mental illness)
Who cannot join
- Youth in foster care
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins Bloomberg School of Public Health
Baltimore, Maryland, 21205
About this study
Official title: Pilot Test of the Better Together Intervention
Better Together (BT) is a novel, culturally relevant library-based intervention designed to prevent substance use among Black youth (ages 11-13) affected by household challenges (i.e., parental substance use, parental incarceration, and parental mental health challenges). In partnership with public and school librarians, the investigators will conduct a randomized pilot study of BT with up to 100 youth across four sites in Baltimore, Maryland to assess:
- Implementation fidelity via logs, assessments, and observations of participants and facilitators
- Feasibility of all key research aspects, including recruitment, randomization, intervention, and control conditions, as well as pre, post, and one-month follow-up assessments
- Initial effects of BT on substance use
Read the detailed description
This study occurred from September 2023 through May 2024 in Baltimore, Maryland, USA. The investigators partnered with two schools to assess the feasibility and acceptability of the BT intervention in a small, randomized trial. The investigators compared the outcomes of Black youth (ages 11-13) exposed to household challenges who received the intervention (n = 32) with a time-matched control group of youth exposed to household challenges (n = 27). An online random number generator was used to randomize participants to either the control or intervention group. Randomization occurred at the family level, which allowed all eligible youth from a single family to be in the same condition and minimized the potential for contamination of intervention effects. Participants completed electronic assessments three times: baseline (one week before the start of the intervention), post-test (one week after the intervention), and a 1-month follow-up (one month after the post-test). The trial ended after implementation in two schools at the end of the school year. The investigators obtained approval from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board.
Youth enrollment occurred one month before the start of the intervention. To be eligible, participants had to be between 11 and 13 years old, identify as Black or African American, and have been exposed to one or more household challenges. Direct youth recruitment occurred with study team members inviting families to participate via presentations at each organization. Participants were also recruited indirectly through referrals from organizational staff and enrolled participants. Recruitment materials and presentations did not include information about household challenges as an eligibility criterion to prevent the risk of stigma associated with participating.
Interested youth were required to complete a participant interest form that included their name, as well as their caregiver's name and contact information. A study team member contacted the caregiver to inform them of the study and assist the caregiver in completing a screener to determine the youth's eligibility. A study team member reviewed the purpose and procedures of the study as outlined on the parental permission form. The permission form was emailed and texted to caregivers via Qualtrics to obtain signatures. Once permission was granted, all eligible youth in the family were assigned a participant ID. Oral assent was obtained from all youth before they completed the baseline survey.
Both intervention and control group sessions occurred twice a week, in person, during non-school hours for four weeks. At most, 15 youth were allowed to participate in each group. Sessions were co-facilitated by two study team members. Participants were compensated $25 for each session they attended and each assessment they completed.
- Conditions
- Substance Use
- Being tested
- Better Together, Youth In the Media (YM)
- Keywords
- substance use, feasibility, adolescents
- 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.
Better TogetherBehavioural
Better Together (BT) is a 90-min, age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use.
Youth In the Media (YM)Behavioural
Delivered in eight in-person, 90-minute sessions concurrently with BT sessions, the YM program was designed to (1) increase participants' awareness of and access to the different types of media and free resources available at the participants local libraries, (2) discuss different types of media that center stories and experiences of Black youth, and (3) expose participants to careers in media.
| Study group | Role | What they receive |
|---|---|---|
| Better Together | Experimental | Better Together (BT) is a 90-min, an age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use. Receives: Behavioral: Better Together |
| Control | Active comparator | Control group participants received a media education program Receives: Behavioral: Youth In the Media (YM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Youth Retained in the intervention
Retention was evaluated in two ways. First, investigators assessed retention by the number of sessions the participant attended (dosage). Investigators defined dosage success as youth participating in five or more sessions. Second, retention was assessed by the proportion of youth who completed the post-test and 1-month follow-up. Investigators defined retention success as more than 80% of the sample was retained at all assessments.
Measured: From enrollment to the completion of the one-month follow-up assessment
Secondary outcomes (2)
Number of Youth who use any substance
One item was used to assess substance use behaviors: "Have you ever had a drink of alcohol (more than a few sips) or tried any drug (i.e., marijuana, cigarette, prescription pills, ecstasy, cocaine, etc.)?" Participants responded, 'yes' or 'no'.
Measured: From baseline to one-month follow-up
Substance use knowledge as assessed by survey
Three true/false items were used to assess substance use knowledge: (1) alcohol is considered a drug, (2) drinking alcohol or using drugs leads to poor judgment and decision-making, and (3) it is against the law for children and teenagers to use drugs. Correct responses were summed to create a scale ranging from 0 to 3. with higher scores indicating more knowledge.
Measured: From baseline to one-month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start1 Sep 2023
- Primary completion1 May 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- More trials run by Johns Hopkins Bloomberg School of Public HealthThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Terrinieka Powell, PhD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06594835
- Sponsor's protocol ID
- IRB00025611
- Acronym
- BT Pilot
- Status last verified
- Sep 2024
- First submitted
- 3 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Powell TW, Offiong A, Lewis Q, Prioleau M, Smith B, Johnson RM. "I've smoked weed with my daughter": Cannabis Use within Families Affected by Parental Opioid Misuse. Child Youth Serv Rev. 2023 Dec;155:107235. doi: 10.1016/j.childyouth.2023.107235. Epub 2023 Oct 15.
PubMed 37982095Powell TW, Smith B, Taye W. Feasibility and acceptability of a novel substance use prevention intervention. Pilot Feasibility Stud. 2026 May 20;12(1):99. doi: 10.1186/s40814-026-01839-1.
PubMed 42157267
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Test of the Better Together Intervention
- ClinicalTrials.gov ID
- NCT06594835
- Acronym / sponsor ID
- BT Pilot / IRB00025611
- Conditions
- Substance Use
- Keywords
- substance use, feasibility, adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 May 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 19 Sep 2024 (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.
Better Together (BT) is a novel, culturally relevant library-based intervention designed to prevent substance use among Black youth (ages 11-13) affected by household challenges (i.e., parental substance use, parental incarceration, and parental mental health challenges). In partnership with public and school librarians, the investigators will conduct a randomized pilot study of BT with up to 100 youth across four sites in Baltimore, Maryland to assess:
- Implementation fidelity via logs, assessments, and observations of participants and facilitators
- Feasibility of all key research aspects, including recruitment, randomization, intervention, and control conditions, as well as pre, post, and one-month follow-up assessments
- Initial effects of BT on substance use
Detailed description
This study occurred from September 2023 through May 2024 in Baltimore, Maryland, USA. The investigators partnered with two schools to assess the feasibility and acceptability of the BT intervention in a small, randomized trial. The investigators compared the outcomes of Black youth (ages 11-13) exposed to household challenges who received the intervention (n = 32) with a time-matched control group of youth exposed to household challenges (n = 27). An online random number generator was used to randomize participants to either the control or intervention group. Randomization occurred at the family level, which allowed all eligible youth from a single family to be in the same condition and minimized the potential for contamination of intervention effects. Participants completed electronic assessments three times: baseline (one week before the start of the intervention), post-test (one week after the intervention), and a 1-month follow-up (one month after the post-test). The trial ended after implementation in two schools at the end of the school year. The investigators obtained approval from the Johns Hopkins Bloomberg School of Public Health Institutional Review Board.
Youth enrollment occurred one month before the start of the intervention. To be eligible, participants had to be between 11 and 13 years old, identify as Black or African American, and have been exposed to one or more household challenges. Direct youth recruitment occurred with study team members inviting families to participate via presentations at each organization. Participants were also recruited indirectly through referrals from organizational staff and enrolled participants. Recruitment materials and presentations did not include information about household challenges as an eligibility criterion to prevent the risk of stigma associated with participating.
Interested youth were required to complete a participant interest form that included their name, as well as their caregiver's name and contact information. A study team member contacted the caregiver to inform them of the study and assist the caregiver in completing a screener to determine the youth's eligibility. A study team member reviewed the purpose and procedures of the study as outlined on the parental permission form. The permission form was emailed and texted to caregivers via Qualtrics to obtain signatures. Once permission was granted, all eligible youth in the family were assigned a participant ID. Oral assent was obtained from all youth before they completed the baseline survey.
Both intervention and control group sessions occurred twice a week, in person, during non-school hours for four weeks. At most, 15 youth were allowed to participate in each group. Sessions were co-facilitated by two study team members. Participants were compensated $25 for each session they attended and each assessment they completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Better Together | Experimental | Behavioral: Better TogetherBetter Together (BT) is a 90-min, an age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use. |
| Control | Active comparator | Behavioral: Youth In the Media (YM)Control group participants received a media education program |
Who may qualify
- Ages
- 11 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- To be eligible, participants had to be between 11 and 13 years old,
- identify as Black or African American,
- have been exposed to one or more household challenges (i.e., parental substance use, incarceration or mental illness)
Key exclusion criteria (1 listed)
- Youth in foster care
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 |
|---|---|---|
| Better TogetherBetter Together (BT) is a 90-min, age-appropriate, culturally relevant prevention intervention to prevent substance use among Black youth experiencing household challenges (ages 11-13) by addressing the multilevel influences of substance use. | Behavioural | Better Together |
| Youth In the Media (YM)Delivered in eight in-person, 90-minute sessions concurrently with BT sessions, the YM program was designed to (1) increase participants' awareness of and access to the different types of media and free resources available at the participants local libraries, (2) discuss different types of media that center stories and experiences of Black youth, and (3) expose participants to careers in media. | Behavioural | Control |
Primary outcome
Number of Youth Retained in the intervention
Time frame: From enrollment to the completion of the one-month follow-up assessment
Retention was evaluated in two ways. First, investigators assessed retention by the number of sessions the participant attended (dosage). Investigators defined dosage success as youth participating in five or more sessions. Second, retention was assessed by the proportion of youth who completed the post-test and 1-month follow-up. Investigators defined retention success as more than 80% of the sample was retained at all assessments.
2 secondary outcomes
Number of Youth who use any substance
Time frame: From baseline to one-month follow-up
Substance use knowledge as assessed by survey
Time frame: From baseline to one-month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 37982095Powell TW, Offiong A, Lewis Q, Prioleau M, Smith B, Johnson RM. "I've smoked weed with my daughter": Cannabis Use within Families Affected by Parental Opioid Misuse. Child Youth Serv Rev. 2023 Dec;155:107235. doi: 10.1016/j.childyouth.2023.107235. Epub 2023 Oct 15.
- Derived from this study: PubMed 42157267Powell TW, Smith B, Taye W. Feasibility and acceptability of a novel substance use prevention intervention. Pilot Feasibility Stud. 2026 May 20;12(1):99. doi: 10.1186/s40814-026-01839-1.
- Website for the research teamLink provided by the sponsor.
- 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.
Terrinieka Powell, PhD principal investigator
Johns Hopkins 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 Better Together and Youth In the Media (YM) in people with Substance Use, run by Johns Hopkins Bloomberg School of Public Health 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 19 Sep 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Number of Youth Retained in the intervention (time frame: From enrollment to the completion of the one-month follow-up assessment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06594835, which also lists 2 linked publications.
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 19 Sep 2024.