Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT06594835
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2024-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Test of the Better Together Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019966', 'term': 'Substance-Related Disorders'}], 'ancestors': [{'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 54}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-12', 'studyFirstSubmitDate': '2024-09-03', 'studyFirstSubmitQcDate': '2024-09-10', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Youth Retained in the intervention', 'timeFrame': 'From enrollment to the completion of the one-month follow-up assessment', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Number of Youth who use any substance', 'timeFrame': 'From baseline to one-month follow-up', 'description': '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\'.'}, {'measure': 'Substance use knowledge as assessed by survey', 'timeFrame': 'From baseline to one-month follow up', 'description': '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.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['substance use', 'feasibility', 'adolescents'], 'conditions': ['Substance Use']}, 'referencesModule': {'references': [{'pmid': '37982095', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://www.researchbypowell.com', 'label': 'Website for the research team'}]}, 'descriptionModule': {'briefSummary': '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:\n\n1. Implementation fidelity via logs, assessments, and observations of participants and facilitators\n2. Feasibility of all key research aspects, including recruitment, randomization, intervention, and control conditions, as well as pre, post, and one-month follow-up assessments\n3. Initial effects of BT on substance use', 'detailedDescription': "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.\n\nYouth 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.\n\nInterested 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.\n\nBoth 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '11 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* To be eligible, participants had to be between 11 and 13 years old,\n* identify as Black or African American,\n* have been exposed to one or more household challenges (i.e., parental substance use, incarceration or mental illness)\n\nExclusion Criteria:\n\n* Youth in foster care'}, 'identificationModule': {'nctId': 'NCT06594835', 'acronym': 'BT Pilot', 'briefTitle': 'Test of the Better Together Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins Bloomberg School of Public Health'}, 'officialTitle': 'Pilot Test of the Better Together Intervention', 'orgStudyIdInfo': {'id': 'IRB00025611'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Better Together', 'description': '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.', 'interventionNames': ['Behavioral: Better Together']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control', 'description': 'Control group participants received a media education program', 'interventionNames': ['Behavioral: Youth In the Media (YM)']}], 'interventions': [{'name': 'Better Together', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Better Together']}, {'name': 'Youth In the Media (YM)', 'type': 'BEHAVIORAL', 'description': "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.", 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bloomberg School of Public Health', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Terrinieka Powell, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins Bloomberg School of Public Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}