A Family-Centered Ojibwe Substance Abuse Prevention
BZDDD
A Randomized Control Trial (RCT) of a Family-Centered Ojibwe Substance Abuse Prevention
1 other identifier
interventional
705
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 26, 2016
CompletedFirst Posted
Study publicly available on registry
March 7, 2016
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2020
CompletedMarch 11, 2022
March 1, 2022
3.8 years
February 26, 2016
March 9, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Change in Cigarette Use
Frequency of use of cigarettes
Pre-Test Baseline, 15 Week, 6 Month
Change in Alcohol Use
Frequency of use of alcohol
Pre-Test Baseline, 15 Week, 6 Month
Change in Illicit Drug Use
Frequency of use of illicit drug use
Pre-Test Baseline, 15 Week, 6 Month
Study Arms (2)
BZDDD Prevention Program Intervention
EXPERIMENTALWe 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.
BZDDD Prevention Program Control
NO INTERVENTIONWe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Youth who self-Identified as American Indian (between the ages of 8-10)
- Adult Guardians of participating youth (aged 18 or older)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Nebraska Lincolnlead
- Johns Hopkins Universitycollaborator
Related Publications (7)
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.
PMID: 22931077BACKGROUNDKeogh-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.
PMID: 17935683BACKGROUNDLang 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.
PMID: 19241171BACKGROUNDHowe 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.
PMID: 17269954BACKGROUNDSpoth 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.
PMID: 11115311BACKGROUNDSpoth 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.
PMID: 11550729BACKGROUNDKosterman 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.
PMID: 11338965BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Leslie B Whitbeck, Ph.D.
University of Nebraska Lincoln
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2016
First Posted
March 7, 2016
Study Start
January 1, 2017
Primary Completion
November 1, 2020
Study Completion
November 1, 2020
Last Updated
March 11, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share
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.