Skip to main content
Clinical Trials/NCT03924167
NCT03924167
Active, not recruiting
Not Applicable

The Weaving Healthy Families Program to Promote Wellness and Resilience and Prevent Alcohol and Other Drug Abuse and Violence

Tulane University1 site in 1 country1,000 target enrollmentAugust 30, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Alcohol Abuse
Sponsor
Tulane University
Enrollment
1000
Locations
1
Primary Endpoint
Change in the DERS-18= Difficulties in Emotional Regulation Scale
Status
Active, not recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 30, 2020
End Date
October 1, 2025
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Catherine E. McKinley

Associate Professor

Tulane University

Eligibility Criteria

Inclusion Criteria

  • Inclusion Criteria for community health representatives (CHR)s.
  • 18 years of age or older
  • have at least a high school degree
  • have experience and/or interest in working with tribal children and families.
  • Exclusion criteria:
  • having less than a high school degree
  • not having experience with tribal families
  • Inclusion criteria for families
  • includes written consent for adults and assent for children ages 12-
  • 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

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

Outcomes

Primary Outcomes

Change in the DERS-18= Difficulties in Emotional Regulation Scale

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

An 18-item measure of emotional regulation and anger management. Sum items for each subscale with Items 1, 4, and 6 being reverse-coded. Add subscale totals for the total summative scale as follows: Awareness (# 1, 4, 6); Clarity (#2, 3, 5); Goals (#8, 12, 15); Impulse (#9, 16, 18); Nonacceptance (#7, 13, 14), and Strategies (#10, 11, 17).

Change in the AADIS= Adolescent Alcohol and Drug Involvement Scale

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Adolescent alcohol and other drug (AOD) use will be assessed using the AADIS, which assesses frequency of AOD as well as 14 items assessing severity of AOD misuse. Scores are added with results indicating: Scores of 0 = No alcohol or other drug use. Scores of 1-36 = Alcohol and/or other drug use present, does not reach threshold for substance use disorder based on DSM-IV criteria. Scores of 37 or higher = Alcohol and/or other drug use present which may reach DSM IV criteria.

Change in the FRI=Family Resilience Scale

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Assesses family resilience in current family and family of origin. Scoring: Add responses for each item. Total scores range from 0-20, with higher scores indicating a higher degree family resilience. Each of the items can be thought of as a protective factor, cumulatively contributing to the holistic measure of family resilience.

Change in the DAS-SF/DAS-C= Dysfunctional Attitudes Scale-Short Form/Child

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Assesses dysfunctional attitudes, which have been shown to be precursors to depression and stress. Items are on a 4-point Likert scale (1-Totally agree to 4-Totally disagree). Items should be scored so that total score reflects greater dysfunctional attitudes. This means that most items will be reverse coded. Subtracting 5 from an item score will reverse score that item. Items are on a 4-point Likert scale (1-Totally agree to 4-Totally disagree).

Change in the AUDIT= Alcohol Use Disorders Identification Test

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

The 10-item AUDIT identifies alcohol consumption, drinking behaviors, and alcohol-related problems among adults. Scores for each question range from 0 to 4, with the first response for each question (eg never) scoring 0, the second (eg less than monthly) scoring 1, the third (eg monthly) scoring 2, the fourth (eg weekly) scoring 3, and the last response (eg. daily or almost daily) scoring 4. For questions 9 and 10, which only have three response, the scoring is 0, 2 and 4 (from left to right). A score of 8 or more is associated with harmful or hazardous drinking, a score of 13 or more in women, and 15 or more in men, is likely to indicate alcohol dependence.

Change in the DAST= Drug Abuse Screening Test

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

A 10-item form used to assess drug use with adults. Participants receive 1 point for every "yes" answer with the exception of question #3, for which a "no" answer receives 1 point. Degree of problems by score: 0=no problems reported, 1-2 = low level, 3-5=moderate level, 6-8=substantial level, 9-10=severe level.

Change in the CRAFFT=Car, Relax, Alone, Forget, Friends, Trouble

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

A 9-item evidenced-based screening tool, will be used to assess AOD misuse, (alcohol and drug use separately and holistically). 9 items. 1-3 number of days used substances. 4-9 yes, no responses with each "yes" response scoring 1 point. A total score of 2 or higher is a positive screen, indicating a need for additional assessment.

Change in the FES=Family Environment Scale-Short Form

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Assesses key components of healthy functioning through the following subscales: cohesion, expressiveness, conflict, independence, achievement orientation, intellectual and cultural orientation, active-recreational orientation, moral-religious emphasis, organization, and control. 90 item scale. Respondents mark whether each item is true (1) = 1 or false (2) =0 for them. Scoring: To determine a person's raw score (RS), count the number of responses in each subscale, and enter the total in the RS box at the bottom. Scores range from 0-10 for each subscale, with higher scores indicating higher levels of that construct. To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family.

Change in the CD-RISC=Conner-Davidson Resilience Scale

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Assesses individual or psychological resilience. 10-item scale. Scoring of the scale is based on summing the total of all items, each of which is scored from 0-4. For the CD-RISC-10, the total score ranges from 0-40. Higher scores indicate higher levels of psychological resilience.

Change in the CTS-2=Conflict Tactics Scale 2

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

The CTS2 is a comprehensive self-reported inventory designed to measure five scales: Negotiation (positive verbal conflict resolution skills), Psychological Aggression, Physical Assault, Sexual Coercion, and Injury. Respondents rate each item on a 7-point Likert- style frequency scale (0 = this has never happened before, 1 = once in the past year, 2 = twice in the past year, 3 = 3-5 time in the past year, 4 = 6-10 times in the past year, 5 = 11-20 times in the past year, 6 = more than 20 times in the past year, and 7 = not in the past year, but it did happen before). To create interpretable scores, values 1 and 2 remained the same, and values 3 through 6 were recoded to be the midpoints (3 = 4, 4 = 8, 5 = 15, 6 = 25). Frequency scores (how often) for each subscale are added (Range 1-12 for frequency, higher scores indicating higher levels of each subscale). Dummy are created with each item and subscale for prevalence (1=yes in the past year; 0=not in the past year).

Change in the BRFSS=Behavioral Risk Factor Surveillance System

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Items taken from the BRFSS on the modules on chronic health, diet, and exercise. Subscales/items: CDC HRQOL- 4-Physical health, mental health, days not good, 4 items. Scoring: To obtain this estimate, responses to questions 2 and 3 are combined to calculate a summary index of overall unhealthy days, with a logical maximum of 30 unhealthy days. Participants were asked whether they had any of 16 chronic health problems (1 yes, 2 no). Scored to create overall measure of health problems. Four diet questions about frequency of consuming. Summed to create mean scores for each item. 4 individual exercise-related questions, individually scored. 4-item HDCM BRFSS (Past 30 days, health-related problems). Score summed. With the exception of the full of energy item, higher scores indicate poorer health.

Alabama Parenting Questionnaire-9/ APQ-SF

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

Measures five dimensions of parenting. 13-item scale. Items (e.g. You threaten to punish your child and then do not actually punish him/her) are rated on a 5 point Likert Scale (1 = never; 2 = almost never; 3 = sometimes; 4 = often; 5 = always). Higher scores indicate higher ratings of the measured parenting practice (i.e. Positive Parenting, Inconsistent Discipline, Poor Supervision).

Change in the SWLS=Satisfaction with Life Scale

Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), 6, 9, and 12 month follow-ups.

A short measure of life satisfaction. The SWLS is a five-item scale designed to measure global judgements about one's life satisfaction. Respondents indicated how much they agreed or disagreed with each of the five items using a seven-point scale that ranged from 'strongly disagree' to 'strongly agree'. The summed scale ranged from 5-35, with higher scores indicating greater life satisfaction.

Secondary Outcomes

  • Change in the PSDQ-SF=Parenting Styles and Dimensions Questionnaire-Short Form(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the SCARED=Screen for Child Anxiety Related Emotional Disorders(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in Communal Mastery Scale(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the SSI=Social Support Index(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the Kidscreen(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the PHQ-9= Patient Health Questionnaire(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the EDS=Everyday Discrimination Scale(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the ACE=Adverse Childhood Experiences(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the PC-PTSD=Primary Care PTSD Screen(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the HLS=Historical Loss Scale-R(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the Intervention AS-36= Evidence-based Practice Attitude Scale(Change from from Baseline and 12 Month Follow-up.)
  • Change in the CSAP = Center for Substance Abuse Prevention (Minority Initiative)(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the GAD-7=Generalized Anxiety Disorder(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the SHALOM= Spiritual Health and Life-Orientation Measure(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the SRHP=Self-Rated Health Practices(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the C-SSRS=Columbia-Suicide Severity Rating Scale(Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups.)
  • Change in the IGI=In-Group Identification(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the HOS=Historical Oppression Scale(Change from Baseline, Pre-test, and Post-test (within one month of completion of intervention).)
  • Change in the ICBS= Implementation Citizenship Behavior Scale(Change from from Baseline and 12 Month Follow-up.)
  • Change in the PSI=Program Sustainability Index(Change from from Baseline and 12 Month Follow-up.)

Study Sites (1)

Loading locations...

Similar Trials