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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02790827
• Date of registration: 24/05/2016
• Prospective Registration: No
• Primary sponsor: Johns Hopkins Bloomberg School of Public Health
• Public title: Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
• Scientific title: Randomized Controlled Trial of a Multi-pronged Intervention to Address Prevention of Violence in Zambia
• Date of first enrolment: May 2016
• Target sample size: 626
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02790827
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Zambia

Contacts

• Name: Laura Murray, PhD
• Affiliation: Johns Hopkins Bloomberg School of Public Health

Key inclusion & exclusion 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



Age minimum: 8 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Mental Health Impairment

Alcoholism

Child Abuse

Domestic Violence

Intervention(s)

Behavioral: Treatment as usual

Behavioral: CETA

Primary Outcome(s)

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(s)

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Secondary ID(s)

IRB00006534

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SHARPZ (Serenity Harm Reduction Programme Zambia)