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Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia

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ClinicalTrials.gov Identifier: NCT02790827
Recruitment Status : Completed
First Posted : June 6, 2016
Last Update Posted : March 15, 2019
Sponsor:
Collaborator:
SHARPZ (Serenity Harm Reduction Programme Zambia)
Information provided by (Responsible Party):
Johns Hopkins Bloomberg School of Public Health

Brief Summary:
This study evaluates the effectiveness of a multi-pronged intervention in reducing and preventing violence against women and children compared to a treatment as usual control group among families living in Lusaka, Zambia.

Condition or disease Intervention/treatment Phase
Domestic Violence Mental Health Impairment Child Abuse Alcoholism Behavioral: CETA Behavioral: Treatment as usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 626 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
Actual Study Start Date : May 2016
Actual Primary Completion Date : January 2019
Actual Study Completion Date : January 2019

Arm Intervention/treatment
Experimental: CETA
Participants in the experimental arm will receive the CETA intervention. The intervention period will last for approximately 4 months with weekly sessions. There will be separate groups for men, women, and children. Each group will have approximately six participants. Individuals who cannot attend group therapy (e.g., conflicting work schedules) may be offered the therapy individually.
Behavioral: CETA
CETA first focuses on: 1) awareness of alcohol problems, violence, and the link between them; 2) gender norms. Skills taught include: changing drinking behaviors, coping with cravings, family dynamics that contribute and result from alcohol use, the role gender plays, and community norms around problem drinking, and cognitive/emotional/behavioral patterns connected with inter-personal violence. The intervention then addresses: 1) positive parenting, 2) positive family relationships, conflict management, and communication skills, 3) attitudes and beliefs about violence, 4) mental health problems and 5) reducing (further) traumatic experiences. The cognitive behavioral therapy (CBT) principles of CETA overlap with the CBT skills for alcohol reduction.

Active Comparator: Treatment as usual
There is no standard of care for domestic violence or alcohol use problems in Zambia. We will track any treatment or care that families receive during the course of the study. The active comparator arm will not receive any formal services provided by the study.
Behavioral: Treatment as usual
The control condition is defined as 'treatment as usual'. In Zambia, there are no formal services or standard of care for alcohol use problems or domestic violence. There are, however, organizations (such as non-governmental organizations) operating in Lusaka that provide intermittent services for these types of problems. Some families receive informal counseling from parish priests or other leaders in their communities. In this study we are therefore defining these types of informal services as 'treatment-as-usual.' We will closely track the type, number, and degree of these kinds of services that all participants receive and access. Following the conclusion of the study, we will offer the CETA intervention to control families if it has been found to be safe and effective.




Primary Outcome Measures :
  1. Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]

Secondary Outcome Measures :
  1. Change in alcohol abuse as measured by the Alcohol Use Disorders Identification Test (AUDIT) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  2. Change in child abuse as measured by the Youth Victimization Scale [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  3. Change in depression symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  4. Change in PTSD symptoms (adult) as measured by the Harvard Trauma Questionnaire (HTQ) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  5. Change in belief about gender norms as measured by the Gender Equitable Mens Scale (GEMS) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  6. Change in child internalizing and externalizing symptoms as measured by the Youth Self Report (YSR) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  7. Change in substance use as measured by the Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  8. Change in child aggression as measured by the Child Aggression Scale [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  9. Change in PTSD symptoms (child) as measured by the Child PTSD Symptom Scale (CPSS) [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  10. Change in chronic stress as measured by hair cortisol [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]
  11. Change in psychological violence as measured by Index of Psychological Abuse [ Time Frame: Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline ]


Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Families living in the study compounds in Lusaka (i.e., not staying temporarily)
  2. Speaking one of the three study languages: English, Bemba, or Nyanja
  3. Having at least one male adult and one female adult 18 years of age or older and in a relationship (married or dating) and one child between the ages of 8 to 17 identified by the mother as the most affected by the violence (if multiple children in the home). Child participation is optional.
  4. The man and woman must both provide consent. If the female agree to have the child participate and the child wants to participate, then parental permission and child assent will be required.
  5. The adult female must indicate during the inclusion screening at least a moderate amount of violence within the family as measured by scoring a 38 or more on the Severity of Violence Against Women Scale (SVAWS).
  6. The male in the family must indicate that he drinks alcohol at hazardous levels or the female must report that the male drinks alcohol at hazardous levels as evidenced by scoring an 8 or higher on the Alcohol Use Disorders Identification Test (AUDIT).

Exclusion Criteria:

  1. Any of the family members is currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2 months)
  2. Any of the family members has had a suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month.
  3. Any of the family members has been diagnosed with a current psychotic disorder (identified by the University Teaching Hospital Psychiatric Unit).
  4. Any of the family members has a serious developmental disorder (e.g., mental retardation, autism) that would preclude participation in cognitive-behavioral oriented skills intervention

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): NCT02790827


Locations
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Zambia
Serenity Harm Reduction Programme Zambia (SHARPZ)
Lusaka, Zambia
Sponsors and Collaborators
Johns Hopkins Bloomberg School of Public Health
SHARPZ (Serenity Harm Reduction Programme Zambia)
Investigators
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Principal Investigator: Laura Murray, PhD Johns Hopkins Bloomberg School of Public Health
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Johns Hopkins Bloomberg School of Public Health
ClinicalTrials.gov Identifier: NCT02790827    
Other Study ID Numbers: IRB00006534
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: March 15, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Alcoholism
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders