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

NCT02790827 | Completed DMC

• 1 other identifier: IRB00006534
• Study Type: interventional
• Target: 626
• Locations: 1 country
• Sites: 1

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.

Conditions

Domestic Violence; Mental Health Impairment; Child Abuse; Alcoholism

Outcome Measures

Primary Outcomes (1)

• Change in violence against women as measured by Severity of Violence Against Women Scale (SVAWS)

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

Secondary Outcomes (11)

• Change in alcohol abuse as measured by the Alcohol Use Disorders Identification Test (AUDIT)

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

• Change in child abuse as measured by the Youth Victimization Scale

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

• Change in depression symptoms as measured by the Center for Epidemiological Studies Depression Scale (CES-D)

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

• Change in PTSD symptoms (adult) as measured by the Harvard Trauma Questionnaire (HTQ)

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

• Change in belief about gender norms as measured by the Gender Equitable Mens Scale (GEMS)

  Baseline, 4-5 months post-baseline, 12 months post-baseline, 24 months post-baseline

Study Arms (2)

CETA

EXPERIMENTAL

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

Treatment as usual

ACTIVE COMPARATOR

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

Interventions

CETA BEHAVIORAL

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.

CETA

Treatment as usual BEHAVIORAL

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.

Treatment as usual

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Families living in the study compounds in Lusaka (i.e., not staying temporarily)
• Speaking one of the three study languages: English, Bemba, or Nyanja
• 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.
• 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.
• 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).

You may not qualify if:

• Any of the family members is currently on an unstable psychiatric drug regimen (i.e., regimen altered in last 2 months)
• Any of the family members has had a suicide attempt or suicidal ideation with intent or plan, or self-harm in the past month.
• Any of the family members has been diagnosed with a current psychotic disorder (identified by the University Teaching Hospital Psychiatric Unit).
• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• SHARPZ (Serenity Harm Reduction Programme Zambia): collaborator

Study Sites (1)

Serenity Harm Reduction Programme Zambia (SHARPZ)

Lusaka, Zambia

Location

Related Publications (1)

• Murray LK, Kane JC, Glass N, Skavenski van Wyk S, Melendez F, Paul R, Kmett Danielson C, Murray SM, Mayeya J, Simenda F, Bolton P. Effectiveness of the Common Elements Treatment Approach (CETA) in reducing intimate partner violence and hazardous alcohol use in Zambia (VATU): A randomized controlled trial. PLoS Med. 2020 Apr 17;17(4):e1003056. doi: 10.1371/journal.pmed.1003056. eCollection 2020 Apr.

  PMID: 32302308 DERIVED

MeSH Terms

Conditions

Alcoholism

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

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

Study Officials

• Laura Murray, PhD

  Johns Hopkins Bloomberg School of Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: June 6, 2016
• Study Start: May 1, 2016
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2019
• Last Updated: March 15, 2019

Record last verified: 2019-03

Locations

ZA (1)