Ignite Creation Date:
2024-05-06 @ 8:18 AM
Last Modification Date:
2024-10-26 @ 11:58 AM
Study NCT ID:
NCT02700035
Status:
COMPLETED
Last Update Posted:
2022-03-11
First Post:
2016-02-26
Brief Title:
A Family-Centered Ojibwe Substance Abuse Prevention
Sponsor:
University of Nebraska Lincoln
Organization:
University of Nebraska Lincoln
Study Overview
Official Title:
A Randomized Control Trial RCT of a Family-Centered Ojibwe Substance Abuse Prevention
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BZDDD
Brief Summary:
This study will complete a multisite randomized controlled trial RCT of a family-centered alcohol and drug prevention program for Anishinabe Ojibwe pre-adolescents in 3rd or 4th grade Fall 2017 or who are age 8-10 years on June 1 2017 The 14 week program includes cultural lessons to strengthen family interactions decrease substance use teach parenting skills increase social skills improve refusal skills and teach coping mechanisms for adolescents and parents Session are expected to last around 3-hours including a meal youth and parent breakout sessions and group based discussions Parents and adolescents will participate in a pre-test before the program begins and a series of post-tests after the program ends
Detailed Description:
Investigators will implement a multisite randomized controlled trial RCT of a family-centered alcohol and drug prevention program for Anishinabe Ojibwe pre-adolescents in 3rd or 4th grade Fall 2017 or who are age 8-10 years on June 1 2017 to assess its efficacy for delaying andor preventing adolescent onset of alcohol and drug use This unique project will empirically address cultural challenges for RCTs involving AI cultures by evaluating contamination and informal diffusion in AI communities and extended families AI values of sharing and community benefits clash with Western RCT methods of withholding benefits from control groups vs treatment groups Although risks of informal community dissemination and control group contamination are widely acknowledged challenges for AI RCTs the degree to which this actually occurs and the potential impact has never been assessed Rather efforts are made to suppress and minimize AI values that result in informal dissemination and contamination or the potential effects are simply ignored This research will address these challenges by attempting to measure and control for them The intent-to-treat study design will allow us to use question routing aimed at identifying content sharing among treatment and control adolescents and their treatment and control group parents Moreover the project will also use question routes to investigate potential contamination via extended family members who have contact with both the treatment and control families Investigators will then assess potential impact of measured contamination on observed intervention effects
At the completion of the study Investigators will work with community research partners to develop a plan to sustain the prevention program A sustainability plan is part of our model for developing and implementing culturally specific evidence-based prevention programs Communities have readiness for sustainability due to familiarity and the popularity of BZDDD We will work through community advisory boards named Prevention Research Councils or PRCs to place the program within schools health services and social services agencies The project will leave behind comprehensive facilitator manuals in addition to a videotaped training program to facilitate ongoing training In addition the program has recently been adapted to a virtual program in response to COVID-19 The investigative team has a proven track record of sustainability in prior adaptions of BZDDD
At the completion of the study Investigators will work with community research partners to develop a plan to sustain the prevention program A sustainability plan is part of our model for developing and implementing culturally specific evidence-based prevention programs Communities have readiness for sustainability due to familiarity and the popularity of BZDDD We will work through community advisory boards named Prevention Research Councils or PRCs to place the program within schools health services and social services agencies The project will leave behind comprehensive facilitator manuals in addition to a videotaped training program to facilitate ongoing training In addition the program has recently been adapted to a virtual program in response to COVID-19 The investigative team has a proven track record of sustainability in prior adaptions of BZDDD
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