The Weaving Healthy Families Program

NCT ID: NCT03924167

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-30
• Study Completion Date: 2025-10-01

Brief Summary

Alcohol and other drug (AOD) abuse and violence in families are co-occurring risk factors that drive health disparities and mortality among Native Americans (NA), making the long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse and violence in NA families by testing an efficacious, sustainable, culturally-relevant and family-centered intervention for cross-national dissemination. The central hypothesis is that the sustainable and community-based Weaving Healthy Families program, will reduce and postpone AOD use among NA adults and youth, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. The expected outcomes of the proposed research are an efficacious, culturally relevant, and sustainable community based program to promote health and wellness that will address the factors that drive health disparities and promote individual, family, and community resilience.

Detailed Description

Alcohol and drug (AOD) abuse and family violence are co-occurring risk factors for Native American (NA) health disparities and are associated with the leading causes of death, such as cardiovascular disease (CVD) and diabetes. However, extant interventions often fail to holistically promote resilience, health, and wellness and instead address problems in isolation. There have been few NA culturally-based and family-focused, interventions that enhance family resilience and prevent and reduce AOD abuse and violence in families. Given the gap in community and culturally-grounded programs to prevent AOD abuse and violence in families, there is a critical need to test the efficacy of such sustainable community-based interventions. The long-term goal of this research is to promote health and wellness, while preventing and reducing AOD abuse and violence in NA families by testing an efficacious, sustainable, culturally-relevant and family-centered intervention for cross-national dissemination. Using community-based participatory research methods (CBPR), the overall objectives of the proposed research is to use a stepped-wedge trial design (SWTD) to test the efficacy of a culturally modified intervention that is facilitated by Tribally-based community health representatives (CHRs) and to use the consolidated framework for implementation research (CFIR) to examine the barriers and facilitators for intervention sustainability and implementation. The central hypothesis is that the sustainable and community-based, "Weaving Healthy Families program"-a shortened and culturally adapted version of the Celebrating Families! Program-will reduce and postpone AOD use, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. This intervention seeks to promote wellness by targeting key behavioral (AOD), mental/emotional (emotional regulation/anger management, cognitions, resilience), social and familial (healthy and safe relationships, the family environment, and parenting), cultural (values, traditions), and physical (nutrition) factors. Investigators test the efficacy and gain knowledge in sustainability and implementation by: Aim 1: Test the efficacy of the modified intervention on AOD and violence reduction and resilience enhancement. Using an open cohort, multiple baseline SWTD and multilevel and longitudinal modeling, investigators will test our working hypothesis that the intervention will reduce parental AOD misuse and violence, postpone youth AOD use, and enhance family members' resilience and wellness. Aim 2: Evaluate the sustainability and feasibility of the intervention's implementation. Investigators will use the CFIR and a convergent mixed-method design to evaluate barriers and facilitators to intervention implementation, testing our working hypothesis that the modified intervention will provide a culturally relevant and feasible model to promote wellness in a sustainable way. The expected outcomes of the proposed research are an efficacious, culturally relevant, and sustainable community based program to promote health and wellness for tribes cross-nationally.

Conditions

Alcohol Abuse; Drug Use; Violence, Domestic; Child Abuse; Diet Modification; Health Behavior; Health Knowledge, Attitudes, Practice; Relationship, Family; Relation, Parent-Child; Emotional Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Families Receiving Weaving Healthy Families 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 Type: EXPERIMENTAL

Weaving Healthy Families Program

Intervention Type: BEHAVIORAL

The Weaving Healthy Families program is created from integrating the widely disseminated, ecological, innovative, and culturally grounded Framework of Historical Oppression, Resilience, and Transcendence (FHORT) with the the Celebrating Families! evidenced-based program (EBP). The goal of this program is to reduce and postpone Alcohol and other Drug (AOD) use, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. This intervention seeks to promote wellness by targeting key behavioral (AOD), mental/emotional (emotional regulation/anger management, cognitions, resilience), social and familial (healthy and safe relationships, the family environment, and parenting), cultural (values, traditions), and physical (nutrition) factors.

Families who have not yet receive the Weaving Healthy Families

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Weaving Healthy Families Program

The Weaving Healthy Families program is created from integrating the widely disseminated, ecological, innovative, and culturally grounded Framework of Historical Oppression, Resilience, and Transcendence (FHORT) with the the Celebrating Families! evidenced-based program (EBP). The goal of this program is to reduce and postpone Alcohol and other Drug (AOD) use, decrease and prevent violence in families, and promote resilience and wellness (including mental health) among NA adults and youth. This intervention seeks to promote wellness by targeting key behavioral (AOD), mental/emotional (emotional regulation/anger management, cognitions, resilience), social and familial (healthy and safe relationships, the family environment, and parenting), cultural (values, traditions), and physical (nutrition) factors.

Intervention Type: BEHAVIORAL

Other Intervention Names

Celebrating Families! Program

Eligibility Criteria

Inclusion Criteria

1. 18 years of age or older

2. have at least a high school degree

3. have experience and/or interest in working with tribal children and families.

1. includes written consent for adults and assent for children ages 12-17.

2. at least one parent/caregiver who is a member of the focal tribe and at least one child, aged 12-18 living in the household

Exclusion Criteria

1. having less than a high school degree

2. not having experience with tribal families

1. current protective order

2. current intimate partner violence (IPV) record will be excluded.

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

NIH

Sponsor Role: collaborator

Tulane University

OTHER

Sponsor Role: lead

Responsible Party

Catherine E. McKinley

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Catherine McKinley

New Orleans, Louisiana, United States

Countries

United States

Other Identifiers

5R01AA028201-03

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2018-1372

Identifier Type: -

Identifier Source: org_study_id