Cultural Program for Substance Abuse and Sexual Activity

(TODOS Trial)

Age: Any Age

Sex: Female

Trial Phase: Academic

Sponsor: Johns Hopkins Bloomberg School of Public Health

Disqualifiers: Planned move, Residential treatment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 14

Duration: 11 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called TODOS (Telling Our Daughters Our Story), which aims to support American Indian girls and their female caregivers in reducing early substance use and sexual activity. The program includes 11 weekly sessions that focus on cultural storytelling and support to strengthen protective factors and decrease risks. Eligible participants are Apache women who care for girls aged 8-11, live near Whiteriver or Fort Apache, Arizona, and can attend all sessions and follow-up activities. As an unphased trial, this study offers participants the chance to contribute to culturally tailored interventions that could benefit their community.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that the TODOS program is safe for participants?

A previous study examined the TODOS program for its effects on risk factors related to substance use and early sexual activity among American Indian children and their caregivers. This trial is labeled "Not Applicable" in terms of phase, indicating that safety testing is not the main focus, and specific safety data for this program might be limited. However, as a non-drug, culturally based program, it is generally expected to be safe. The program typically includes discussions and activities designed to educate and support participants, using cultural stories and teachings instead of new medications or medical procedures. Therefore, physical side effects are unlikely, but participants should feel comfortable with the content and facilitators to ensure a positive experience. ¹

Why are researchers excited about this trial?

Researchers are excited about the "Telling Our Daughters Our Story" (TODOS) program because it takes a unique cultural approach to addressing substance abuse and sexual activity among young people. Unlike typical interventions that might focus solely on education or behavioral therapy, TODOS emphasizes storytelling and cultural connection, fostering a deeper understanding and personal resonance. This method aims to strengthen family bonds and cultural identity, which can be powerful motivators for positive change. By focusing on cultural narratives, the program offers a fresh, community-centered perspective that could enhance current prevention strategies.

What evidence suggests that the TODOS program is effective for reducing early substance use and sexual debut?

Research has shown that cultural programs like TODOS, which participants in this trial may receive, can reduce the likelihood of early substance use and sexual activity. Studies emphasize addressing these issues within a cultural context, especially for American Indian communities. Programs involving family and community support have shown promise in creating protective factors that help prevent risky behaviors. Although specific data on TODOS's success is limited, similar culturally tailored programs have improved outcomes by strengthening family connections and raising awareness. TODOS uses storytelling and cultural heritage to empower young girls and their caregivers, potentially leading to positive long-term changes. ^{1 2}

Who Is on the Research Team?

Mary Barlow, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am a girl between the ages of 8 and 11.

I can see well and think clearly enough to fill out forms.

I am a caregiver of a girl aged 8-11 who can join the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the TODOS program consisting of 11 weekly sessions with girls and their female caregivers

11 weeks

11 sessions (in-person)

Control Condition

Participants in the control group receive 3 monthly group sessions with community activities

3 months

3 sessions (in-person)

Follow-up

Participants are monitored for changes in risky behaviors, cultural knowledge, and reproductive health knowledge

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)

Trial Overview 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.

How Is the Trial Designed?

Group I: TODOS Intervention Experimental Treatment 1 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 Community Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Johns Hopkins Bloomberg School of Public Health

Lead Sponsor

Trials

441

Recruited

2,157,000+

Native American Research Center for Health

Collaborator

Trials

6

Recruited

1,300+

White Mountain Apache Tribe

Collaborator

Trials

2

Recruited

280+

Native American Research Centers for Health

Collaborator

Trials

5

Recruited

890+

Published Research Related to This Trial

The Asdzáán Be'eená program, designed for Navajo girls aged 8 to 11 and their caregivers, showed promising results in increasing self-esteem, self-efficacy, and cultural knowledge, as well as improving parent-child relationships and communication after 3 months.

Caregivers also reported enhanced family engagement in Navajo culture and better child functioning, indicating that the program may effectively reduce risk factors for substance use and teen pregnancy in Native communities, although further rigorous studies are needed to confirm its effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility, Acceptability, and Preliminary Impact of Asdzáán Be'eená: An Intergenerational, Strength-Based, and Culturally Grounded Program to Improve the Health of Navajo Families. Chambers, RA., Patel, H., Richards, J., et al.[2023]

The Thiwáhe Gluwáš'akapi Program (TG) was culturally adapted for American Indian youth and showed significant improvements in key areas such as parental communication about substance use and youth resistance skills, indicating its potential effectiveness in preventing early substance use.

Both youth and adults reported positive changes in family dynamics and overall well-being, suggesting that the program not only addresses substance use prevention but also strengthens family relationships, which are crucial for supporting healthy development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Grounding evidence-based prevention within cultural context: promising effects of substance use prevention adapted for American Indian families. Asdigian, NL., Tuitt, N., Mousseau, AC., et al.[2023]

The Wakȟáŋyeža (Little Holy One) intervention is a culturally-based program aimed at reducing intergenerational trauma and improving parenting among Fort Peck Assiniboine and Sioux families, utilizing a randomized controlled trial design with 1:1 randomization of parent-child dyads.

The intervention focuses on addressing trauma symptoms and stress in parents, with secondary outcomes including improvements in parenting practices and child behavior, suggesting a potential upstream approach to reduce children's risk for substance use and suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wakȟáŋyeža (Little Holy One) - an intergenerational intervention for Native American parents and children: a protocol for a randomized controlled trial with embedded single-case experimental design. Brockie, T., Haroz, EE., Nelson, KE., et al.[2022]

The Talking Circle intervention significantly improved Native-Reliance among 75 Native American participants aged 18-24, indicating a positive cultural impact on their well-being.

At 6 months post-intervention, participants showed significant reductions in stress, behavioral health issues, substance use, depression, and cumulative trauma, demonstrating the effectiveness of culturally safe interventions in addressing trauma-related issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Talking Circle For Young Adults (TC4YA) intervention: a culturally safe research exemplar. Lowe, J., Millender, E., Best, O.[2022]

The Shadow Project, a 3-year pilot study involving 60 American Indian families, tested a culturally adapted family-enhanced intervention for youth entering substance use treatment, showing promising links between cultural storytelling and improved youth prosocial behavior and abstinence rates.

The study highlighted the importance of integrating cultural elements into treatment, with preliminary findings suggesting that culturally responsive interventions can positively influence family dynamics and support youth in achieving and maintaining abstinence from drugs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A culturally responsive, family-enhanced intervention model. Boyd-Ball, AJ.[2015]

Citations

1. withpower.com withpower.com/trial/phase-substance-related-disorders-2-2019-cfa66

Cultural Program for Substance Abuse and Sexual Activity ... This project will evaluate the impact of "Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (henceforth referred to as TODOS) on associated risk and ...

2. psychologytoday.com psychologytoday.com/us/blog/the-athletes-way/201607/harvard-study-pegs-how-parental-substance-abuse-impacts-kids

Harvard Study Pegs How Parental Substance Abuse ... This study reports that children whose parents use drugs and misuse alcohol are three times more likely to be physically, sexually, or emotionally abused.