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Behavioral Intervention

TODOS Intervention for Substance Abuse (TODOS Trial)

N/A
Waitlist Available
Led By Mary Barlow, PhD
Research Sponsored by Johns Hopkins Bloomberg School of Public Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 11 weeks, 6 months, 12 months
Awards & highlights

TODOS Trial Summary

This trial aims to assess the effectiveness of a culturally grounded program called "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story" on American Indian (AI) female

Who is the study for?
This trial is for American Indian female children and their female caregivers living on the White Mountain Apache reservation. It aims to evaluate a program designed to reduce early substance use and sexual activity by strengthening cultural connections.Check my eligibility
What is being tested?
The study compares the 'Telling Our Daughters Our Story' (TODOS) program with regular community group activities over three months, assessing its impact on risk factors for substance abuse and early sexual initiation.See study design
What are the potential side effects?
Since this trial involves educational and community-based interventions rather than medical treatments, there are no direct side effects like those associated with medications or clinical procedures.

TODOS Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 11 weeks, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 11 weeks, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in average score on risky behaviors assessment
Change in child cultural knowledge score on knowledge assessment
Change in child reproductive health knowledge via a reproductive health knowledge questionnaire

TODOS Trial Design

2Treatment groups
Experimental Treatment
Group I: TODOS InterventionExperimental Treatment1 Intervention
Participants in the TODOS Intervention Group will receive the intervention "Nowhi Isdza bit Nadagoldi": Telling Our Daughters Our Story. They will receive 11 intervention sessions of 60-90 minutes over 11 weeks.
Group II: Control condition - 3 Monthly Group Activities in the CommunityExperimental Treatment1 Intervention
Children and their female caregivers randomized to the control group will receive 3 group sessions delivered monthly for three months. The first group session will occur at a community center and will consist of a meal and ice breaker activities. The second group session will consist of going to a movie at the local movie theatre. The third group session will consist of going bowling at the local bowling alley.

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Who is running the clinical trial?

Johns Hopkins Bloomberg School of Public HealthLead Sponsor
410 Previous Clinical Trials
2,116,747 Total Patients Enrolled
1 Trials studying Substance Abuse
322 Patients Enrolled for Substance Abuse
White Mountain Apache TribeUNKNOWN
1 Previous Clinical Trials
100 Total Patients Enrolled
Native American Research Centers for HealthUNKNOWN
3 Previous Clinical Trials
354 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are potential participants still able to apply for enrollment in this ongoing research study?

"As per clinicaltrials.gov, this specific trial is currently not in the recruitment phase. It was initially posted on 30th March 2019 and last modified on 22nd February 2024. Despite this trial no longer seeking participants, it's noteworthy that there are a total of 358 ongoing studies actively accepting enrollees at present."

Answered by AI
~30 spots leftby Apr 2025