The Weaving Healthy Families Program

NCT03924167 | Active Not Recruiting

• 2 other identifiers: 2018-13725R01AA028201-03
• Study Type: interventional
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (13)

• Change in the AUDIT= Alcohol Use Disorders Identification Test

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

• Change in the DAST= Drug Abuse Screening Test

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

• Change in the AADIS= Adolescent Alcohol and Drug Involvement Scale

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

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

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

• Change in the FES=Family Environment Scale-Short Form

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

• Change in the FRI=Family Resilience Scale

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

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

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

• Change in the CTS-2=Conflict Tactics Scale 2

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

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

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

• Change in the SWLS=Satisfaction with Life Scale

  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.

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

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

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

• Change in the BRFSS=Behavioral Risk Factor Surveillance System

  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.

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

• Alabama Parenting Questionnaire-9/ APQ-SF

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

Secondary Outcomes (20)

• 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 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 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 Kidscreen

  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.

Study Arms (2)

Families Receiving Weaving Healthy Families Intervention

EXPERIMENTAL

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.

Behavioral: Weaving Healthy Families Program

Families who have not yet receive the Weaving Healthy Families

NO INTERVENTION

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

Interventions

Weaving Healthy Families Program 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.

Also known as: Celebrating Families! Program

Families Receiving Weaving Healthy Families Intervention

Eligibility Criteria

• Age: 5 Years - 120 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• have at least a high school degree
• have experience and/or interest in working with tribal children and families.

You may not qualify if:

• having less than a high school degree
• not having experience with tribal families
• includes written consent for adults and assent for children ages 12-17.
• 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
• current protective order
• current intimate partner violence (IPV) record will be excluded.

Sponsors & Collaborators

• Tulane University: lead
• National Institute on Alcohol Abuse and Alcoholism (NIAAA): collaborator

Study Sites (1)

Catherine McKinley

New Orleans, Louisiana, 70125, United States

Location

MeSH Terms

Conditions

Alcoholism; Health Behavior; Behavior; Stress, Psychological

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Families and CHRs will be blinded to the order they receive the intervention and notified a month in advance.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: April 11, 2019
• First Posted: April 23, 2019
• Study Start: August 30, 2020
• Primary Completion: May 1, 2025
• Study Completion: October 1, 2025
• Last Updated: February 20, 2024

Record last verified: 2024-02

Locations

US (1)