Clinical trial NCT03924167: The Weaving Healthy Families Program
Official title: The Weaving Healthy Families Program to Promote Wellness and Resilience and Prevent Alcohol and Other Drug Abuse and Violence
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Alcohol Abuse
Drug Use
Violence, Domestic
Child Abuse
Diet Modification
Health Behavior
Health Knowledge, Attitudes, Practice
Relationship, Family
Relation, Parent-Child
Emotional Stress
Lead sponsor: Tulane University
Sponsor class: OTHER
Collaborators: name: National Institute on Alcohol Abuse and Alcoholism (NIAAA)
First posted: 2019-04-23
Enrollment: 1000
Sex: ALL
Minimum age (years): 5
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The proposed research will 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 the consolidated framework for implementation research (CFIR) to examine the barriers and facilitators for intervention sustainability and implementation.
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

1. Inclusion Criteria for community health representatives (CHR)s.

   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.
2. Exclusion criteria:

   1. having less than a high school degree
   2. not having experience with tribal families
3. Inclusion criteria for 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
4. Exclusion Criteria:

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

Primary outcomes:
measure: Change in the AUDIT= Alcohol Use Disorders Identification Test
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the DAST= Drug Abuse Screening Test
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the AADIS= Adolescent Alcohol and Drug Involvement Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the CRAFFT=Car, Relax, Alone, Forget, Friends, Trouble
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the FES=Family Environment Scale-Short Form
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the FRI=Family Resilience Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the CD-RISC=Conner-Davidson Resilience Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the CTS-2=Conflict Tactics Scale 2
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the DAS-SF/DAS-C= Dysfunctional Attitudes Scale-Short Form/Child
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the SWLS=Satisfaction with Life Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the DERS-18= Difficulties in Emotional Regulation Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Change in the BRFSS=Behavioral Risk Factor Surveillance System
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
measure: Alabama Parenting Questionnaire-9/ APQ-SF
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.
Secondary outcomes:
measure: Change in the CSAP = Center for Substance Abuse Prevention (Minority Initiative)
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the PSDQ-SF=Parenting Styles and Dimensions Questionnaire-Short Form
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the SRHP=Self-Rated Health Practices
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the Kidscreen
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the GAD-7=Generalized Anxiety Disorder
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the SCARED=Screen for Child Anxiety Related Emotional Disorders
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the PHQ-9= Patient Health Questionnaire
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the PC-PTSD=Primary Care PTSD Screen
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the C-SSRS=Columbia-Suicide Severity Rating Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the SHALOM= Spiritual Health and Life-Orientation Measure
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in Communal Mastery Scale
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the SSI=Social Support Index
timeFrame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.
measure: Change in the IGI=In-Group Identification
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the HOS=Historical Oppression Scale
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the HLS=Historical Loss Scale-R
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the EDS=Everyday Discrimination Scale
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the ACE=Adverse Childhood Experiences
timeFrame: Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).
measure: Change in the ICBS= Implementation Citizenship Behavior Scale
timeFrame: Change from from Baseline and 12 Month Follow-up.
measure: Change in the Intervention AS-36= Evidence-based Practice Attitude Scale
timeFrame: Change from from Baseline and 12 Month Follow-up.
measure: Change in the PSI=Program Sustainability Index
timeFrame: Change from from Baseline and 12 Month Follow-up.
Other outcomes:
Locations:
city: New Orleans
country: United States
facility: Catherine McKinley
state: Louisiana
Study officials:
References: