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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03924167
Recruitment Status : Recruiting
First Posted : April 23, 2019
Last Update Posted : April 23, 2019
Sponsor:
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Catherine, Tulane University

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.

Condition or disease Intervention/treatment Phase
Alcohol Abuse Drug Use Violence, Domestic Child Abuse Diet Modification Health Behavior Health Knowledge, Attitudes, Practice Relationship, Family Relation, Parent-Child Emotional Stress Behavioral: Weaving Healthy Families Program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
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.
Masking: Double (Participant, Care Provider)
Masking Description: Families and CHRs will be blinded to the order they receive the intervention and notified a month in advance.
Primary Purpose: Prevention
Official Title: The Weaving Healthy Families Program to Promote Wellness and Resilience and Prevent Alcohol and Other Drug Abuse and Violence
Actual Study Start Date : January 28, 2019
Estimated Primary Completion Date : October 1, 2025
Estimated Study Completion Date : October 1, 2025

Arm Intervention/treatment
Experimental: 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 (4-7); (c) children (8-10); and (d) adolescent (11-18) 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
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.
Other Name: Celebrating Families! Program

No Intervention: 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.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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).

  5. 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 (e.g., cohesion, communication, resilience, and organization). 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. To determine the family's mean RS for each subscale, average the subscale raw scores for all members of that family.

  6. 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.

  7. 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. 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.

  8. 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. ]
    Assesses intimate partner violence (IPV) and positive couple dynamics. Respondents rate each item for the aforementioned scales 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).

  9. 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).

  10. 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.

  11. 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).

  12. 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.


Secondary Outcome Measures :
  1. Change in the CSAP = Center for Substance Abuse Prevention (Minority Initiative) [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Secondary measures of AOD abuse among youth and adults.

  2. Change in the PSDQ-SF=Parenting Styles and Dimensions Questionnaire-Short Form [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of parenting styles, which are associated with more optimum and less optimum parent-child relationships. Each item of the scale were evaluated with the five points likert described as, "never", "once in a while", "about half of the time", "very often", "always" . Scores for each authoritarian, authoritative, and permissive parenting styles are achieved by creating the mean for each construct with higher scores indicating higher levels of the given construct.

  3. Change in the SRHP=Self-Rated Health Practices [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of health self-efficacy. The 28-item Self-Rated Abilities for Health Practices Scale (SRHP), which is a 5-point scale ("not at all" = 0 to "completely" = 4) to measure perceived ability to implement health promoting behavior. Scores range from 0-112, with higher scores indicating greater health practices self-efficacy.

  4. Change in the Kidscreen [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of health self-efficacy among youth.

  5. Change in the GAD-7=Generalized Anxiety Disorder [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of anxiety symptoms for adults. This seven-item, self-report questionnaire focused on symptoms of feeling nervous, anxious or on edge, not being able to stop or control worrying, and having trouble relaxing. Respondents rated the how often they experienced these symptoms over the past two weeks (0 = not at all, 3 = nearly every day). Scores ranged from 0-21 with higher scores indicating more severe symptoms.

  6. Change in the SCARED=Screen for Child Anxiety Related Emotional Disorders [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of anxiety symptoms for youth.

  7. Change in the PHQ-9= Patient Health Questionnaire [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of depressive symptoms for adults. Participant's indicate how often over the past two weeks they were bothered by depressive symptoms. For each of the nine items, four response options were available. These were: 0 = 'not at all', 1 = 'several days', 2 = 'more than half the days', and 3 = 'nearly every day'. When summed, the nine scale items had a possible range of 0 to 27 and the total score corresponded to an individual's level of depressive symptoms along a continuum that was scored as: minimal (score of 0-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27) depression. PHQ-9 scores of 10 or higher indicate clinical depression, a cut point validated across numerous studies.

  8. Change in the PC-PTSD=Primary Care PTSD Screen [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of PTSD for adults. Preliminary results from validation studies suggest that a cut-point of 3 on the PC-PTSD-5 (e.g., respondent answers "yes" to any 3 of 5 questions about how the traumatic event(s) have affected them over the past month) is optimally sensitive to probable PTSD. Optimizing sensitivity minimizes false negative screen results. Using a cut-point of 4 is considered optimally efficient. Optimizing efficiency balances false positive and false negative results.

  9. Change in the C-SSRS=Columbia-Suicide Severity Rating Scale [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of suicide symptoms for adults. Add symptoms of suicidal ideation (0/1). Any score greater than 0 indicates some level of suicide ideation. A score of 4 (active suicidal ideation with some intent to act) or 5 (active suicidal ideation with specific plan and intent) on suicidal ideation indicate serious suicidal ideation.

  10. Change in the SHALOM= Spiritual Health and Life-Orientation Measure [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of spiritual health and wellness. Spiritual well-being is assessed using the Spiritual Health and Life-Orientation Measure (SHALOM), which is a 20-item scale investigating spiritual dimensions of life. Item responses range from 1 (very low) to 5 (very high). These are added and an overall mean is created, with higher scores indicating higher spiritual well-being.

  11. Change in the RRC-ARM/CYRMA =Resilience Research Centre - Adult Resilience Measure/Child and Youth Resilience Measure [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of community resilience for adults and youth. Items are added with Likert scale from 1 (Not at all) to 5 (A lot), with higher scores indicating higher levels of resilience.

  12. Change in Communal Mastery Scale [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of community resilience and cohesion.

  13. Change in the SSSU=Social Support and Social Undermining [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of social support and negative social dynamics. Social support and social undermining were measured with 20 total items using Likert-type scale ranging from 1 (never) to 3 (often) to assess the following subscales: emotional social support, instrumental social support, and critical appraisal with higher scores indicating higher levels of each of the constructs.

  14. Change in the SSI=Social Support Index [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of social, familial, and community support. The 17 items are coded as follows: 1 Strongly disagree; 2 Disagree; 3 Neutral; 4 Agree; or 5 Strongly Agree. Scores are added to indicate levels of social and familial support (higher scores, higher support). Some items (7, 9, 10, 14, 17) are reversed coded.

  15. Change in the IGI=In-Group Identification [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of ethnic identity.

  16. Change in the HOS=Historical Oppression Scale [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of perceived historical oppression. Add responses for each item. Total scores range from 10-50, with higher scores indicating a higher degree of reported historical oppression.

  17. Change in the HLS=Historical Loss Scale-R [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of perceived historical loss. The Historical Loss Scale (HLS) is an adapted version, creating a 15 time scale measuring the frequency with which people think of historical loss from a continuum of the following: 1 = 'several times a day'; 2 = 'daily'; 3 = 'weekly'; 4 = 'monthly'; 5 = 'yearly or at special times'; and 6 = 'never'. The following items were added the following culturally relevant items to the original 12-item scale: "Loss of family unity and increase in family violence"; "Loss of respect for women"; and "Losses from man-made disasters, flooding, pollution, and destruction of natural resources." Responses were summed (range = 15-75) and higher values indicated a higher degree of historical loss.

  18. Change in the EDS=Everyday Discrimination Scale [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of perceived discrimination. This 5-item scale measures the frequency 5 (every day) to 0 (never) that people experience discrimination, with higher scores indicating greater perceived discrimination.

  19. Change in the ACE=Adverse Childhood Experiences [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of child maltreatment and childhood stress and trauma. Yes/no items are added indicating total numbers of adverse childhood events.

  20. Change in the CBCL=Child Behavioral Checklist [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    Measure of child well-being and mental health.

  21. Change in the ICBS= Implementation Citizenship Behavior Scale [ Time Frame: Change from Baseline,12, and 27 Month Follow-up. ]
    Measure of facilitator behaviors and attitudes about the intervention. The six items of this scale are added (0=not at all to 5=frequently if not always) with higher scores indicating higher levels of practitioners exceeding expected job tasks.

  22. Change in the Intervention AS-36= Evidence-based Practice Attitude Scale [ Time Frame: Change from Baseline,12, and 27 Month Follow-up. ]
    Measure of consolidated framework for implementation research. Items for this 36-item scale are added with 0=not at all to 5-very great extent, with higher scores indicating the better fit for this intervention.

  23. Change in the PSI=Program Sustainability Index [ Time Frame: Change from Baseline,12, and 27 Month Follow-up. ]
    Measure of Program Sustainability. Items are added from 0=not at all true to 2=very much true for an overall measure of program sustainability.

  24. AAPI-2=Adult-Adolescent Parenting Inventory-2 [ Time Frame: Change from Baseline, Pre-test, Post-test (within one month of completion of intervention), and 12 month follow-ups. ]
    The AAPI-2 is an inventory to assess the parenting and child rearing attitudes of adult and adolescent parent and pre-parent populations.

  25. Change in Consolidated Framework for Implementation Research (CFIR) [ Time Frame: Change from Baseline,12, and 27 Month Follow-up. ]
    Qualitative changes are assessed according to the frameworks dimensions.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   5 Years to 120 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 12-17.
  • 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

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03924167


Contacts
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Contact: Catherine E Burnette, PhD 504-862-3495 cburnet3@tulane.edu
Contact: Katherine P Theall, PhD 504-988-4535 ktheall@tulane.edu

Locations
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United States, Louisiana
Tulane University School of Social Work Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Catherine E Burnette, PhD    504-439-6234    cburnet3@tulane.edu   
Sponsors and Collaborators
Tulane University
National Institutes of Health (NIH)
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Responsible Party: Catherine, Assistant Professor, Tulane University
ClinicalTrials.gov Identifier: NCT03924167    
Other Study ID Numbers: 2018-1372
First Posted: April 23, 2019    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alcoholism
Substance-Related Disorders
Stress, Psychological
Alcohol-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Behavioral Symptoms