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

NCT05471921 | Completed Results

• 1 other identifier: AAAU0532
• Study Type: interventional
• Target: 400
• Locations: 2 countries
• Sites: 2

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.

Conditions

Alcohol and Substance-Related Mental Disorders

Keywords

Alcohol Use Disorder; Substance Use Disorders; Depression; Anxiety; Trauma

Outcome Measures

Primary Outcomes (1)

• Change in Alcohol Use Disorders Identification Test (AUDIT) Score

  AUDIT is a 10-item measure of hazardous alcohol use with a possible range of 0-40 (total scale score). Higher scores are associated with more hazardous use.

  Baseline, 6-months, 12-months

Secondary Outcomes (6)

• Change in Center for Epidemiologic Studies - Depression Scale (CES-D) Score

  Baseline, 6-months, 12-months

• Change in Generalized Anxiety Disorder-7 Scale (GAD-7) Score

  Baseline, 6-months, 12-months

• Change in Harvard Trauma Questionnaire (HTQ)

  Baseline, 6-months, 12-months

• Alcohol, Smoking, and Substance Involvement Screening Test (ASSIST): Risk Score (Continuous Outcome)

  Baseline, 6-months, 12-months

• Number of Participants Who Had Any Substance Use in the Past 3 Months, Based on Responses to the ASSIST Questionnaire

  Baseline, 6-months, 12-months

Study Arms (2)

SBIRT

EXPERIMENTAL

Experimental condition: Participants residing in the study community (displaced and host population) will receive Screening, Brief Intervention, and Referral to Treatment (SBIRT). The treatment will consist of brief intervention (CETA-BI) and full Common Elements Treatment Approach (CETA) depending on the severity of the participant's substance use.

Behavioral: SBIRT

Treatment as usual

ACTIVE COMPARATOR

Comparison condition: Participants residing in the study community (displaced and host population) will receive the current standard of treatment.

Behavioral: Treatment as usual

Interventions

SBIRT BEHAVIORAL

SBIRT is an evidence-based treatment for unhealthy alcohol and other drugs (AOD) use in non-humanitarian settings and can efficiently provide individuals with an appropriate level of care based on their symptoms. Participants randomized to SBIRT will receive an on-the-spot alcohol brief intervention (CETA-BI) and be categorized as low or moderate/high severity using the AUDIT scale. Participants who are moderate/high severity will be connected to a counselor and will begin full CETA treatment. CETA is a transdiagnostic approach that combines motivational interviewing with cognitive behavioral therapy to assist clients in considering changing their rates of AOD use. The intervention lasts 30-40 minutes and consists of 6 components including 1) screening; 2) identifying the impacts of unhealthy AOD use; 3) talking about change/goal-setting; 4) understanding the primary reason for drinking; 5) skill-building; and 6) referral for services.

SBIRT

Treatment as usual BEHAVIORAL

Mantapala health workers and supervisors were trained in mental health gap action program-humanitarian intervention guide (mhGAP-HIG), which is a mental health service provision guide for use in humanitarian settings; this training was led by staff from United Nations High Commissioner for Refugees. This training did not include evidence-based psychological interventions (e.g., CETA). Participants randomized to TAU will be referred to the existing services that exist in the health clinic located in Mantapala refugee settlement. More specialized services are referred to the District Hospital in Nchelenge.

Treatment as usual

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Living in Mantapala refugee settlement (i.e., Congolese refugee) or (Zambian) member of neighboring host community

You may not qualify if:

• 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

Sponsors & Collaborators

• Columbia University: lead
• Elrha: collaborator

Study Sites (2)

Columbia University

New York, New York, 10032, United States

Location

Mantapala Refugee Settlement

Nchelenge, Luapula Province, Zambia

Location

MeSH Terms

Conditions

Alcoholism; Substance-Related Disorders; Depression; Anxiety Disorders; Wounds and Injuries

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Alcohol-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Jeremy Kane
• Organization: Columbia University

jk4397@cumc.columbia.edu

212-305-2862

Study Officials

• Jeremy Kane, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Claire Greene, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

• Muzi Kamanga

  Women in Law and Development in Africa (WiLDAF)

  PRINCIPAL INVESTIGATOR

• Henry Loongo, PhD

  CARE Zambia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be randomized to SBIRT or treatment as usual (TAU) control. The Research Assistant (RA) will allocate participants to study conditions using a series of sealed, opaque envelopes. RAs and data analysts will be blinded. Participants will be notified immediately about the result of the randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Epidemiology

Study Record Dates

• First Submitted: July 21, 2022
• First Posted: July 25, 2022
• Study Start: April 26, 2023
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: November 6, 2025
• Results First Posted: November 6, 2025

Record last verified: 2025-10

Locations

ZA (1); US (1)