N/A N=400 Randomized Single-blind Treatment

Effectiveness of an Evidence-based Stepped Care System for Alcohol and Other Drug Use Problems Among Congolese Refugees in Zambia

Alcohol and Substance-Related Mental Disorders

Bottom Line

View on ClinicalTrials.gov: NCT05471921 ↗

Enrolled (actual)

400

Serious AEs

2.3%

Results posted

Nov 2025

Primary outcome: Primary: Change in Alcohol Use Disorders Identification Test (AUDIT) Score — -12.6; -8.1; -13.8; -10.3 score on a scale

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: SBIRT (Behavioral); Treatment as usual (Behavioral)
Age: Pediatric, Adult, Older Adult · 15+ yrs
Sex: All
Sponsor: Columbia University
Primary completion: Feb 2025

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Alcohol Use Disorders Identification Test (AUDIT) Score	-12.6; -8.1; -13.8; -10.3	—
SECONDARY Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score	-9.5; -5.8; -8.9; -8.1	—
SECONDARY Change in Generalized Anxiety Disorder-7 Scale (GAD-7) Score	-3.6; -2.1; -3.5; -3.2	—
SECONDARY Change in Harvard Trauma Questionnaire (HTQ)	-0.5; -0.4; -0.5; -0.5	—
SECONDARY Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)	-28.3; -23.0; -30.4; -26.1	—
SECONDARY Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire	60; 55; 24; 33; 18; 22	—
SECONDARY Sleep Scale for the Medical Outcomes Research Study	—	—

Summary

This is a randomized controlled trial (RCT) evaluating the effectiveness of a screening, brief intervention, and referral to treatment (SBIRT) stepped-care system in reducing unhealthy AOD use among Congolese refugees and the host community in Mantapala, an integrated settlement in northern Zambia.

Eligibility Criteria

Inclusion Criteria

Living in Mantapala refugee settlement (i.e., Congolese refugee) or (Zambian) member of neighboring host community
Unhealthy alcohol use based on standard cut-off scores of the ACASI-based Alcohol Use Disorders Identification Test (AUDIT)20 (≥ 8 for men and ≥ 4 for women).21 The focus on unhealthy alcohol use as the primary inclusion criterion is due to preliminary research in Mantapala suggesting that alcohol is the main substance of concern and other drug use almost exclusively co-occurs with alcohol use.

Exclusion Criteria

Severe psychiatric illness, high suicide risk (based on recent attempts and/or ideation with intent and plan), and/or current severe AOD withdrawal that would necessitate immediate referral for psychiatric services
Inability or unwillingness to provide informed consent

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05471921). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.