A Family-Centered Ojibwe Substance Abuse Prevention

Not Applicable

Completed

• Conditions: Substance Use
• Interventions: Other: Bii-Zin-Da-De-Dah (Listening to One Another)

• Registration Number: NCT02700035
• Lead Sponsor: University of Nebraska Lincoln

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 and/or 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.

Study Timeline

• Study First Submitted: 2016-02-26
• Study First Submitted QC: 2016-03-01
• Study First Posted: 2016-03-07
• Study Start: 2017-01
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-09
• Last Update Posted: 2022-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 705

Inclusion Criteria

• Youth who self-Identified as American Indian (between the ages of 8-10)
• Adult Guardians of participating youth (aged 18 or older)

Exclusion Criteria

• Youth who did not self-identify as American Indian
• Youth under the age of 8 years old
• Youth over the age of 11 years old.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BZDDD Prevention Program Intervention	Bii-Zin-Da-De-Dah (Listening to One Another)	We employed an experimental randomized block (RB) design; blocked on reservation where 157 were assigned to the intervention condition (Bii-Zin-Da-De-Dah (Listening to One Another) 14 week family based prevention program). The first 4 weeks of the program are oriented towards the Anishinabe cultural traditions and the traditional Anishinabe family. Weeks 5 through 8 focus on identifying feelings and how to manage negative feelings such as anger and sadness in positive ways. The last 6 weeks of the program focus on outside influences and how to build positive support systems. Prior to the intervention, we completed a pre-test with families in the experimental group. Following the program, we completed a post-test and a 6-month youth follow-up.

Primary Outcome Measures

Name	Time	Method
Change in Illicit Drug Use	Pre-Test Baseline, 15 Week, 6 Month	Frequency of use of illicit drug use
Change in Cigarette Use	Pre-Test Baseline, 15 Week, 6 Month	Frequency of use of cigarettes
Change in Alcohol Use	Pre-Test Baseline, 15 Week, 6 Month	Frequency of use of alcohol