Substance UseBZDDDNCT02700035
A Family-Centered Ojibwe Substance Abuse Prevention
A study testing Bii-Zin-Da-De-Dah (Listening to One Another) in people with Substance Use, run by University of Nebraska Lincoln.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Use
- What is being tested?
- Bii-Zin-Da-De-Dah (Listening to One Another)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 705 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Youth who self-Identified as American Indian (between the ages of 8-10)
- Adult Guardians of participating youth (aged 18 or older)
Who cannot join
- 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.
About this study
Official title: A Randomized Control Trial (RCT) of a Family-Centered Ojibwe Substance Abuse Prevention
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.
Read the 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.
- Conditions
- Substance Use
- Being tested
- Bii-Zin-Da-De-Dah (Listening to One Another)
- Keywords
- Intervention, Prevention, Randomized Controlled Trial, Bii-Zin-Da-De-Dah
- Medical subject headings
- Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bii-Zin-Da-De-Dah (Listening to One Another)Other
Also called BZDDD
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cigarette Use
Frequency of use of cigarettes
Measured: Pre-Test Baseline, 15 Week, 6 Month
Change in Alcohol Use
Frequency of use of alcohol
Measured: Pre-Test Baseline, 15 Week, 6 Month
Change in Illicit Drug Use
Frequency of use of illicit drug use
Measured: Pre-Test Baseline, 15 Week, 6 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2016 (estimated)
- Study startJan 2017
- Primary completionNov 2020
- Study completionNov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Substance UseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 705 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nebraska Lincoln
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Leslie B Whitbeck, Ph.D., Principal investigator, University of Nebraska Lincoln
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02700035
- Sponsor's protocol ID
- 14158
- Acronym
- BZDDD
- Status last verified
- Mar 2022
- First submitted
- 26 Feb 2016
- Last updated
- 11 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: 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.
Publications
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.
PubMed 22931077Keogh-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.
PubMed 17935683Lang 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.
PubMed 19241171Howe 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.
PubMed 17269954Spoth 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.
PubMed 11115311Spoth 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.
PubMed 11550729Kosterman 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.
PubMed 11338965
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial (RCT) of a Family-Centered Ojibwe Substance Abuse Prevention
- ClinicalTrials.gov ID
- NCT02700035
- Acronym / sponsor ID
- BZDDD / 14158
- Conditions
- Substance Use
- Keywords
- Intervention, Prevention, Randomized Controlled Trial, Bii-Zin-Da-De-Dah
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 705 participants (actual)
- Lead sponsor
- University of Nebraska LincolnUniversity, hospital or other
- Collaborators
- Johns Hopkins University
- Study start
- Jan 2017 (actual)
- Primary completion
- Nov 2020 (actual)
- Study completion
- Nov 2020 (actual)
- First posted
- 7 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BZDDD Prevention Program Intervention | Experimental | Other: 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. |
| 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. |
Who may qualify
- Ages
- 8 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Youth who self-Identified as American Indian (between the ages of 8-10)
- Adult Guardians of participating youth (aged 18 or older)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bii-Zin-Da-De-Dah (Listening to One Another)Also: BZDDDBii-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. | Other | BZDDD Prevention Program Intervention |
Primary outcome
Change in Cigarette Use
Time frame: Pre-Test Baseline, 15 Week, 6 Month
Frequency of use of cigarettes
Change in Alcohol Use
Time frame: Pre-Test Baseline, 15 Week, 6 Month
Frequency of use of alcohol
Change in Illicit Drug Use
Time frame: Pre-Test Baseline, 15 Week, 6 Month
Frequency of use of illicit drug use
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2022.
- Background: PubMed 22931077Whitbeck 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.
- Background: PubMed 17935683Keogh-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.
- Background: PubMed 19241171Lang 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.
- Background: PubMed 17269954Howe 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.
- Background: PubMed 11115311Spoth 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.
- Background: PubMed 11550729Spoth 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.
- Background: PubMed 11338965Kosterman 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie B Whitbeck, Ph.D. principal investigator
University of Nebraska Lincoln
Questions about this trial
What is this clinical trial studying?
A study testing Bii-Zin-Da-De-Dah (Listening to One Another) in people with Substance Use, run by University of Nebraska Lincoln.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Cigarette Use (time frame: Pre-Test Baseline, 15 Week, 6 Month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02700035, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2022.