Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594835
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-03
Brief Title:
Test of the Better Together Intervention
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot Test of the Better Together Intervention
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BT Pilot
Brief 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 ie 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
1 Implementation fidelity via logs assessments and observations of participants and facilitators
2 Feasibility of all key research aspects including recruitment randomization intervention and control conditions as well as pre post and one-month follow-up assessments
3 Initial effects of BT on substance use
1 Implementation fidelity via logs assessments and observations of participants and facilitators
2 Feasibility of all key research aspects including recruitment randomization intervention and control conditions as well as pre post and one-month follow-up assessments
3 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 caregivers 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 youths 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
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 caregivers 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 youths 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None