Weaving Healthy Families Program for Substance Use and Domestic Violence

Overseen By Katherine P Theall, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Current protective order, IPV record

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

Compensation: Varies

Number of Visits: 7

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to promote health and wellness among Native American families by reducing alcohol and drug abuse and preventing family violence. It focuses on testing a community-based program called Weaving Healthy Families, which supports families in building resilience, improving mental health, and enhancing parenting skills. Families qualify if they have at least one parent from the focal tribe and a child aged 12-18 living at home, with no current protective orders or records of intimate partner violence. As an unphased trial, the study offers families the chance to contribute to community health initiatives and access supportive resources.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Weaving Healthy Families Program is safe for families?

Research on the Weaving Healthy Families Program has not provided specific safety data. However, this program offers a community-based and culturally relevant approach to help families address substance use and violence.

The trial is labeled "Not Applicable" in terms of phase, indicating a focus on developing an effective program rather than testing a new drug. This suggests the program itself is unlikely to cause physical side effects like a medication might. Instead, it provides support and education.

Programs like this are generally well-received and aim to strengthen family support systems and resilience, leading to positive outcomes. While research has not reported negative effects, participants should consult the trial team with any concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Weaving Healthy Families Program because it offers a comprehensive, family-centered approach to tackling substance use and domestic violence. Unlike standard treatments that often focus solely on the individual, this program integrates cognitive-behavioral strategies across different age groups within the family, from young children to adolescents and caregivers. This holistic method not only aims to reduce substance abuse but also strengthens family unity, enhances parenting skills, and addresses mental health issues, potentially leading to more resilient and healthier family environments.

What evidence suggests that the Weaving Healthy Families Program is effective for reducing substance use and domestic violence?

Research has shown that the Weaving Healthy Families Program holds promise in helping Native American families become more resilient and reducing the risk of substance abuse and violence. This community-based program specifically addresses issues like alcohol and drug abuse, prevents domestic violence, and improves mental health. Participants in this trial will either receive the Weaving Healthy Families intervention or join a baseline group that has not yet received it. Those who participated in the program reported better overall wellness and stronger family bonds. The program includes all family members, focusing on improving parenting skills and building family strength. These early results suggest the program could help tackle health challenges in Native American communities. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for Native American families with at least one parent/caregiver who is a member of the focal tribe and has a child aged 12-18. Adults must be over 18, have at least a high school education, and an interest in working with tribal families. Families currently dealing with intimate partner violence or protective orders are excluded.

Inclusion Criteria

You have worked with or are interested in working with children and families from tribal communities.

I am a parent from the specific tribe with a child aged 12-18 living with me.

have at least a high school degree

Exclusion Criteria

having less than a high school degree

current protective order

current intimate partner violence (IPV) record will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Data collection prior to receiving the intervention in this stepped-wedge trial design

1 month

1 visit (in-person)

Intervention

Families receive the Weaving Healthy Families curriculum, a cognitive-behavioral, support group model aimed at reducing AOD abuse and promoting wellness

6 months

Monthly sessions (in-person)

Follow-up

Participants are monitored for changes in AOD use, violence, and resilience through various assessments

12 months

Follow-up assessments at 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Weaving Healthy Families Program

Trial Overview The Weaving Healthy Families Program aims to reduce alcohol and drug abuse, prevent family violence, and improve wellness among Native Americans. It's a culturally-tailored program that focuses on promoting resilience within individuals, families, and communities.

How Is the Trial Designed?

Group I: Families Receiving Weaving Healthy Families Intervention Experimental Treatment 1 Intervention

The Weaving Healthy Families curriculum is a cognitive-behavioral, support group model for high-risk families related to alcohol, tobacco, or other drugs (ATOD) and/or or domestic violence, child abuse, or neglect. This curriculum is tailored for all ages (i.e., (a) parents/caregivers; (b) early childhood (5-7); (c) children (8-11); and (d) adolescent (12-17) and is aimed at reducing alcohol and other drug (AOD) abuse, promote unity, address mental health problems, strengthen parenting skills, and bolster wellness and resilience.

Group II: Families who have not yet receive the Weaving Healthy Families Active Control 1 Intervention

Baseline group --data will be collected prior to receiving the intervention in this stepped-wedge trial design.

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

Collaborator

Trials

865

Recruited

1,091,000+

Published Research Related to This Trial

The National Partnership for Maternal Safety has developed a Consensus Bundle on Obstetric Care specifically for pregnant and postpartum women with opioid use disorder, aiming to standardize care and improve maternal and neonatal health outcomes.

Implementation resources and quality improvement initiatives are being created to help healthcare providers adopt these evidence-based recommendations, ensuring consistent and safe care for women affected by substance use during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

National Partnership for Maternal Safety: Consensus Bundle on Obstetric Care for Women With Opioid Use Disorder. Krans, EE., Campopiano, M., Cleveland, LM., et al.[2021]

The intervention, which included intensive home visits and case management for high-risk women of child-bearing age, showed significant improvements in 14 out of 16 assessed areas, indicating its effectiveness in reducing substance use.

The study found strong correlations between substance use and factors like mental health, social support, and self-efficacy, highlighting the importance of addressing these domains in substance use interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multifaceted intervention strategy for reducing substance use in high-risk women. Loudenburg, R., Leonardson, GR.[2019]

A new Plan of Safe Care was developed to improve perinatal support for families affected by parental substance use, addressing barriers to accessing prenatal care and treatment services.

This plan promotes care coordination by engaging both patients and healthcare providers, facilitating better delivery planning and resource alignment for families with substance use disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Facilitating Integrated Perinatal Care for Families Affected by Substance Use. Schmidt, CN., Patel, D., Alpers, BS., et al.[2023]

Collaboration between agencies addressing substance abuse treatment and child welfare significantly improves child safety, parental recovery, and overall family well-being, based on data from over 15,000 families served by 53 federal grantees.

The study highlights effective strategies that can help reduce negative outcomes for families affected by substance use disorders, emphasizing the importance of integrated support systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Promising Results for Cross-Systems Collaborative Efforts to Meet the Needs of Families Impacted by Substance Use. Dennis, K., Rodi, MS., Robinson, G., et al.[2016]

The Nurturing Program for Families in Substance Abuse Treatment and Recovery effectively improves parenting skills and enhances parents' satisfaction and competence, as shown by objective scales and participant reports.

The program is grounded in principles that have been proven to reduce the risks of child abuse, neglect, and substance abuse for both parents and children, indicating its potential for long-term positive outcomes in affected families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Parenting services for families affected by substance abuse. Moore, J., Finkelstein, N.[2004]

Women receiving integrated care for substance abuse during pregnancy reported feeling more comfortable with healthcare teams that maintained a consistent nonjudgmental attitude.

Effective communication among providers and between providers and patients, along with support groups, were key factors in enhancing the overall care experience for these women.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participant perception of an integrated program for substance abuse in pregnancy. Lefebvre, L., Midmer, D., Boyd, JA., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8274525/

Weaving Healthy Families Program: Promoting Resilience ... Results reveal promising preliminary results for the WHF program to promote resilience and thriving while reducing risk for substance abuse and violence in NA ...

2. withpower.com withpower.com/trial/phase-alcoholism-7-2020-1b044

Weaving Healthy Families Program for Substance Use and ... Trial Overview The Weaving Healthy Families Program aims to reduce alcohol and drug abuse, prevent family violence, and improve wellness among Native Americans.

3. ctv.veeva.com ctv.veeva.com/study/the-weaving-healthy-families-program

The Weaving Healthy Families Program - ClinicalTrials.Veeva Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10382600/

The Weaving Healthy Families program: Promoting ... No participants requested assistance, families with active violence or SUD abuse were excluded. Families came from a Southeastern federally ...

5. researchgate.net researchgate.net/publication/370361576_McKinley_et_al_2023_Developing_the_Weaving_Healthy_Families_Program_to_promote_wellness_and_prevent_SUD_and_violence

McKinley et al. (2023). Developing the Weaving Healthy ... A culturally grounded and community-based program aimed at preventing violence and AOD use while promoting mental health, resilience, and wellness in ...

6. bmcpublichealth.biomedcentral.com bmcpublichealth.biomedcentral.com/articles/10.1186/s12889-022-14528-4

Promoting permanency in families with parental substance ... Within the child welfare system, parental substance use is increasingly implicated in substantiated allegations of abuse and neglect [7].

7. samhsa.gov samhsa.gov/sites/default/files/family_treatment_paper508v.pdf

Family-Centered Treatment for Women With Substance Use ... safety provisions in families with a history of child abuse or neglect. ... Poverty, domestic violence, child abuse, substance abuse, divorce, and emotional ...

8. acf.gov acf.gov/sites/default/files/documents/cb/synthesis_of_findings_substance_abuse_child_welfare.pdf

SYNTHESIS OF FINDINGS Substance Abuse Child ... U.S. Department of Health and Human Services, Administration for Children and Families. Synthesis of Findings: Substance Abuse Child Welfare Waiver ...

9. cdn.ymaws.com cdn.ymaws.com/www.safestates.org/resource/resmgr/imported/Weaving%20a%20Safety%20Net%20-%20Integrating%20Injury%20Prevention%20%26%20MCH.pdf

Integrating Injury and Violence Prevention into Maternal and ... ... child with special health care needs: child abuse and neglect prevention, including shaken baby syndrome prevention; residential safety; safe sleep; crib ...