Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II

Summary

Purpose: This study is testing a new counseling program called Counselling for Alcohol Problems in Pregnancy or CAP-Pre, designed to help pregnant women in South Africa to reduce their alcohol use and improve their well-being. Alcohol use during pregnancy can harm babies, leading to Fetal Alcohol Spectrum Disorders (FASD), which can cause lifelong health and developmental problems. Currently, there are no community-based support programs to help pregnant women struggling with alcohol use.

What Happens in the Study? 40 pregnant women will take part in the study and will be randomly assigned to one of two groups:

1. CAP-Pre + Standard Health Advice - Women will receive five counseling sessions to help them reduce drinking, plus usual pregnancy care.
2. Standard Health Advice Only - Women will receive usual pregnancy care and an information booklet on alcohol use in pregnancy.

The study will test:

The study will evaluate if CAP-Pre is easy to deliver, acceptable, and helps women to drink less. (measured by self-report and a blood test).

Why Is This Important? South Africa has the highest rates of FASD in the world, but most pregnant women do not receive specialized support for harmful alcohol use. If this pilot study is successful, it will help prepare for a more extensive study to test whether CAP-Pre can be widely used in antenatal care programs.

Who Is Involved? The study is run by researchers from Germany and South Africa, with funding from the German Alliance for Global Health Research.

Conditions

• Alcohol Use Disorder

Interventions

BEHAVIORAL

The Counselling for Alcohol Problems in Pregnancy (CAP-Pre) intervention

Five structured 60-minute counseling sessions (weekly, CHW-delivered). Key components: Motivational interviewing (MI) to enhance behavior change. Cognitive-behavioral strategies (CBT) for managing alcohol cravings. Goal-setting and self-monitoring for tracking progress. Problem-solving techniques and social support enhancement.

Sponsors & Collaborators

• Technical University of Munich

  collaborator OTHER

• Medical Research Council, South Africa

  collaborator OTHER

• Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH

  lead OTHER

Principal Investigators

• Daniela C Fuhr, Prof. · Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH

• Patel Peterson Williams, Prof. · Medical Research Council, South Africa

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-10

Primary Completion

2025-05-31

Completion

2025-07-31

Countries

• South Africa

Study Locations