NCT02700035

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

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
705

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 26, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 7, 2016

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

March 11, 2022

Status Verified

March 1, 2022

Enrollment Period

3.8 years

First QC Date

February 26, 2016

Last Update Submit

March 9, 2022

Conditions

Keywords

InterventionPreventionRandomized Controlled TrialBii-Zin-Da-De-Dah

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

EXPERIMENTAL

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.

Other: Bii-Zin-Da-De-Dah (Listening to One Another)

BZDDD Prevention Program Control

NO INTERVENTION

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.

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.

Also known as: BZDDD
BZDDD Prevention Program Intervention

Eligibility Criteria

Age8 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

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

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: 22931077BACKGROUND
  • 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.

    PMID: 17935683BACKGROUND
  • 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.

    PMID: 19241171BACKGROUND
  • 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.

    PMID: 17269954BACKGROUND
  • 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.

    PMID: 11115311BACKGROUND
  • 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.

    PMID: 11550729BACKGROUND
  • 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.

    PMID: 11338965BACKGROUND

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Leslie B Whitbeck, Ph.D.

    University of Nebraska Lincoln

    PRINCIPAL INVESTIGATOR

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.