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A Family-Centered Ojibwe Substance Abuse Prevention (BZDDD)

Primary Purpose

Substance Use

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bii-Zin-Da-De-Dah (Listening to One Another)
Sponsored by
University of Nebraska Lincoln
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Substance Use focused on measuring Intervention, Prevention, Randomized Controlled Trial, Bii-Zin-Da-De-Dah

Eligibility Criteria

8 Years - 100 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    BZDDD Prevention Program Intervention

    BZDDD Prevention Program Control

    Arm Description

    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.

    We employed a randomized block (RB) design; blocked on reservation, 147 families were randomly assigned to the control condition. We completed a post-test and a 6-month youth follow-up.

    Outcomes

    Primary Outcome Measures

    Change in Cigarette Use
    Frequency of use of cigarettes
    Change in Alcohol Use
    Frequency of use of alcohol
    Change in Illicit Drug Use
    Frequency of use of illicit drug use

    Secondary Outcome Measures

    Full Information

    First Posted
    February 26, 2016
    Last Updated
    March 9, 2022
    Sponsor
    University of Nebraska Lincoln
    Collaborators
    Johns Hopkins University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02700035
    Brief Title
    A Family-Centered Ojibwe Substance Abuse Prevention
    Acronym
    BZDDD
    Official Title
    A Randomized Control Trial (RCT) of a Family-Centered Ojibwe Substance Abuse Prevention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2017 (Actual)
    Primary Completion Date
    November 2020 (Actual)
    Study Completion Date
    November 2020 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Nebraska Lincoln
    Collaborators
    Johns Hopkins University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Substance Use
    Keywords
    Intervention, Prevention, Randomized Controlled Trial, Bii-Zin-Da-De-Dah

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    705 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    BZDDD Prevention Program Intervention
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    BZDDD Prevention Program Control
    Arm Type
    No Intervention
    Arm Description
    We employed a randomized block (RB) design; blocked on reservation, 147 families were randomly assigned to the control condition. We completed a post-test and a 6-month youth follow-up.
    Intervention Type
    Other
    Intervention Name(s)
    Bii-Zin-Da-De-Dah (Listening to One Another)
    Other Intervention Name(s)
    BZDDD
    Intervention Description
    Bii-Zin-Da-De-Dah (Listening to One Another) is a family-centered alcohol and drug prevention program for Anishinabe communities. It was the first American Indian adaptation of the Iowa Strengthening Families Program (now called the Strengthening Families Program). This program has been developed and adapted in partnership with multiple Anishinabe communities over a span of 13 years. Bii-Zin-Da-De-Dah has been enormously popular in communities. It is currently the center piece of a National Canadian Mental Health Promotion Program funded by the Public Health Agency of Canada. Now in its third Phase, focusing on national scale-up among first nations people, it has been adapted for eight cultures and translated into French in a recent implementation in Canada.
    Primary Outcome Measure Information:
    Title
    Change in Cigarette Use
    Description
    Frequency of use of cigarettes
    Time Frame
    Pre-Test Baseline, 15 Week, 6 Month
    Title
    Change in Alcohol Use
    Description
    Frequency of use of alcohol
    Time Frame
    Pre-Test Baseline, 15 Week, 6 Month
    Title
    Change in Illicit Drug Use
    Description
    Frequency of use of illicit drug use
    Time Frame
    Pre-Test Baseline, 15 Week, 6 Month

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    8 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Leslie B Whitbeck, Ph.D.
    Organizational Affiliation
    University of Nebraska Lincoln
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Due to the nature of the collaboration with tribal entities, the data will not be made publicly available without approval of the collaborating tribal council government bodies.
    Citations:
    PubMed Identifier
    22931077
    Citation
    Whitbeck LB, Walls ML, Welch ML. Substance abuse prevention in American Indian and Alaska Native communities. Am J Drug Alcohol Abuse. 2012 Sep;38(5):428-35. doi: 10.3109/00952990.2012.695416.
    Results Reference
    background
    PubMed Identifier
    17935683
    Citation
    Keogh-Brown MR, Bachmann MO, Shepstone L, Hewitt C, Howe A, Ramsay CR, Song F, Miles JN, Torgerson DJ, Miles S, Elbourne D, Harvey I, Campbell MJ. Contamination in trials of educational interventions. Health Technol Assess. 2007 Oct;11(43):iii, ix-107. doi: 10.3310/hta11430.
    Results Reference
    background
    PubMed Identifier
    19241171
    Citation
    Lang DL, DiClemente RJ, Hardin JW, Crosby RA, Salazar LF, Hertzberg VS. Threats of cross-contamination on effects of a sexual risk reduction intervention: fact or fiction. Prev Sci. 2009 Sep;10(3):270-5. doi: 10.1007/s11121-009-0127-z.
    Results Reference
    background
    PubMed Identifier
    17269954
    Citation
    Howe A, Keogh-Brown M, Miles S, Bachmann M. Expert consensus on contamination in educational trials elicited by a Delphi exercise. Med Educ. 2007 Feb;41(2):196-204. doi: 10.1111/j.1365-2929.2006.02674.x.
    Results Reference
    background
    PubMed Identifier
    11115311
    Citation
    Spoth RL, Redmond C, Shin C. Reducing adolescents' aggressive and hostile behaviors: randomized trial effects of a brief family intervention 4 years past baseline. Arch Pediatr Adolesc Med. 2000 Dec;154(12):1248-57. doi: 10.1001/archpedi.154.12.1248.
    Results Reference
    background
    PubMed Identifier
    11550729
    Citation
    Spoth RL, Redmond C, Shin C. Randomized trial of brief family interventions for general populations: adolescent substance use outcomes 4 years following baseline. J Consult Clin Psychol. 2001 Aug;69(4):627-42. doi: 10.1037//0022-006x.69.4.627.
    Results Reference
    background
    PubMed Identifier
    11338965
    Citation
    Kosterman R, Hawkins JD, Haggerty KP, Spoth R, Redmond C. Preparing for the drug free years: session-specific effects of a universal parent-training intervention with rural families. J Drug Educ. 2001;31(1):47-68. doi: 10.2190/3KP9-V42V-V38L-6G0Y.
    Results Reference
    background

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    A Family-Centered Ojibwe Substance Abuse Prevention

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