Alcohol and Substance Related Mental Disorders / SBIRT · Interventional Study

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed RCT registration evaluating a stepped-care SBIRT system for alcohol and substance use in Congolese refugees in Zambia. No results are posted in this registry record; the source reports only protocol and enrollment.

What was studied

Interventional, Randomized, Parallel, Single masking, Treatment purpose. Alcohol and Substance-Related Mental Disorders; age from 15 Years. Intervention: SBIRT. Compared with: Treatment as usual — Active Comparator. n = 400. 2 sites: United States, Zambia.

Key findings

Safety

Results are not reported in this registry record; efficacy, safety, and outcome data are unavailable.

Who this may help

The source did not state who this applies to in practice.

Plain-language summary

This is a completed trial registration with no results posted; the source reports only protocol and enrollment facts, not outcomes or efficacy data.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Change in Alcohol Use Disorders Identification Test (AUDIT) Score (assessed at Baseline, 6-months, 12-months)

DesignInterventional, Randomized, Parallel, Single masking, Treatment purpose

PopulationAlcohol and Substance-Related Mental Disorders; age from 15 Years

Sample size400

InterventionSBIRT

ComparatorTreatment as usual — Active Comparator

Setting2 sites: United States, Zambia

Reported figures

Quoted from the source exactly as published.

Planned enrollment400

Primary outcome measureChange in Alcohol Use Disorders Identification Test (AUDIT) Score

Assessment timepointsBaseline, 6-months, 12-months

Caveats

Results are not reported in this registry record; efficacy, safety, and outcome data are unavailable.
Blinding status, allocation concealment method, and follow-up completion rates are not described.
No effect sizes, confidence intervals, or p-values are provided.
Publication status of trial results is not stated in the registry entry.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

strong

Randomized controlled trial comparing SBIRT intervention to treatment as usual.

Directness

strong

Primary outcome is AUDIT score change, a validated measure of alcohol use disorder severity.

Consistency

insufficient

No results reported in this registry record; cannot assess consistency.

Risk of bias

insufficient

Registry record does not describe blinding, allocation concealment, or loss to follow-up.

Sample adequacy

moderate

400 participants enrolled; adequacy depends on effect size assumptions not stated here.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT05471921). This is a study registration, not published results. Lead sponsor: Columbia University. Recruitment status: COMPLETED. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 400 participants (ACTUAL). Conditions: Alcohol and Substance-Related Mental Disorders. Interventions: BEHAVIORAL: SBIRT; BEHAVIORAL: Treatment as usual. Primary outcome measures: Change in Alcohol Use Disorders Identification Test (AUDIT) Score , Baseline, 6-months, 12-months. Brief 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.

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

Alcohol and Substance Related Mental DisordersSBIRTColumbia UniversityNCT05471921