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

183 Participants Needed

Trial Summary

What is the purpose of this trial?

The objective of this research study is to evaluate a culturally grounded program among American Indian (AI) female children and the children's female caregivers. 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 protective factors for early substance use and sexual debut through a randomized controlled trial on the White Mountain Apache (WMA) reservation. The investigators will examine whether the TODOS program effectively reduces risk factors and improves protective factors associated with early substance use and sexual debut, with long term goals of reducing teen pregnancy and teen substance use.

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 data supports the effectiveness of the treatment Nowhi Isdza bit Nadagoldi: Telling Our Daughters Our Story (TODOS)?

Research on similar culturally grounded programs, like Asdzáán Be'eená and Thiwáhe Gluwá'šakapi, shows that incorporating cultural teachings can improve family communication, self-esteem, and resistance to substance use, suggesting that the TODOS program might also be effective in reducing substance abuse and risky behaviors. ^{1 2 3 4 5}

Is the Cultural Program for Substance Abuse and Sexual Activity safe for humans?

The research articles reviewed do not provide specific safety data for the Cultural Program for Substance Abuse and Sexual Activity or its related programs like TODOS. However, similar culturally adapted programs for substance abuse prevention in Native American communities have shown positive impacts on well-being and reduced substance use, suggesting they are generally safe and beneficial. ^{3 6 7 8 9}

How is the TODOS treatment different from other treatments for substance abuse and sexual activity?

The TODOS treatment is unique because it incorporates cultural teachings and storytelling specifically tailored for American Indian communities, focusing on mother-daughter relationships to prevent substance abuse and teen pregnancy. This culturally sensitive approach is designed to resonate with the community's values and traditions, which is often missing in standard treatments. ^{3 4 6 10 11}

Research Team

Mary Barlow, PhD

Principal Investigator

Johns Hopkins Bloomberg School of Public Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

La Cultura Cura: Latino Culture, Shared Experiences, and Recovery in Northern Californian Anexos. [2022]

2. United States 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Grounding evidence-based prevention within cultural context: promising effects of substance use prevention adapted for American Indian families. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Diné (Navajo) Female Perspectives on Mother-Daughter Cultural Assets Around the Transition to Womanhood: A Qualitative Study. [2022]

5. Ireland pubmed.ncbi.nlm.nih.gov

Impacts of the respecting the circle of life teen pregnancy prevention program on risk and protective factors for early substance use among native American youth. [2022]

6. England pubmed.ncbi.nlm.nih.gov

The Community Pulling Together: A Tribal Community–University Partnership Project to Reduce Substance Abuse and Promote Good Health in a Reservation Tribal Community. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Beyond primary prevention of alcohol use: a culturally specific secondary prevention program for Mexican heritage adolescents. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Talking Circle For Young Adults (TC4YA) intervention: a culturally safe research exemplar. [2022]

9. England pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

Developing culturally sensitive HIV/AIDS and substance abuse prevention curricula for Native American youth. [2019]

11. England 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. [2022]