NCT06853873

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 10, 2025

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

March 3, 2025

Status Verified

February 1, 2025

Enrollment Period

3 months

First QC Date

February 25, 2025

Last Update Submit

February 25, 2025

Conditions

Alcohol Use Disorder

Keywords

Alcohol misusepregnancyWomenPsychoeducationLay Health WorkersSouth AfricaAlcohol use in PregnancyCounseling SessionsPsychoeducational Intervention

Outcome Measures

Primary Outcomes (1)

  • Self-Reported Alcohol Consumption assessed using the Alcohol Timeline Follow Back (TLFB)

    Alcohol use will be assessed using the Alcohol Timeline Follow Back (TLFB) method, a retrospective self-report tool that estimates daily drinking volume over the past month. This method provides a structured recall of alcohol consumption patterns, allowing for detailed quantification of drinking behavior.

    Changes from Baseline to Post Intervention in 6 weeks

Secondary Outcomes (4)

  • Biological Marker of Alcohol Use assessed using Phosphatidylethanol (PeTH) testing

    Changes from Baseline to Post Intervention in 6 weeks

  • Psychosocial functioning assessed using WHO-Disability Assessment Schedule (WHO-DAS)

    Changes from Baseline to Post Intervention in 6 weeks

  • Depressive Symptoms assessed using Edinburgh Postnatal Depression Scale (EPDS)

    Changes from Baseline to Post Intervention in 6 weeks

  • Alcohol-Related Consequences assessed using Alcohol Use Disorder Identification Test - Consumption (AUDIT-C)

    Changes from Baseline to Post Intervention in 6 weeks

Study Arms (2)

Enhanced Usual Care (EUC)

NO INTERVENTION

Information booklet on alcohol use in pregnancy. Referral to antenatal services if needed. No structured counseling was provided.

CAP-Pre + Enhanced Usual Care

EXPERIMENTAL

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

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

Interventions

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

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.

Also known as: CAP-PRE
CAP-Pre + Enhanced Usual Care

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study exclusively includes pregnant women (gender females) who are ≤28 weeks gestation at the time of recruitment. The rationale for this gender-based inclusion is that pregnancy-related alcohol consumption and its associated risks, such as Fetal Alcohol Spectrum Disorders (FASD), are biologically specific to individuals who can become pregnant. Given the study's focus on interventions for reducing alcohol use during pregnancy, men and non-pregnant individuals are not eligible.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women ≤28 weeks gestation.
  • Alcohol Use Risk: Hazardous alcohol use, defined as an Alcohol Use Disorder Identification Test (AUDIT) score of 8-20.
  • Age ≥18 years old at the time of recruitment.
  • Consent: Ability to provide written informed consent and willingness to participate in the study

You may not qualify if:

  • Severe Mental Health Conditions: Diagnosed psychotic disorders or severe cognitive impairment that may interfere with participation.
  • High-Risk Pregnancy: Presence of significant pregnancy complications that require specialized medical care.
  • Substance Dependence (Other Than Alcohol): Current dependence on drugs other than alcohol and tobacco requiring specialized treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South African Medical Research Council (SAMRC)

Cape Town, PO Box 19070, Tygerberg, 7505, South Africa

Location

Related Publications (2)

  • Wan X, Fang M, Chen T, Wang H, Zhou Q, Wei Y, Zheng L, Zhou Y, Chen K. Corrigendum to "The mechanism of low-dose radiation-induced upregulation of immune checkpoint molecule expression in lung cancer cells" [Biochem. Biophys. Res. Commun. 608 (2022 Jun 11) 102-107, doi: 10.1016/j.bbrc.2022.03.158. Epub 2022 Apr 2.PMID: 35397421]. Biochem Biophys Res Commun. 2023 Oct 26:149132. doi: 10.1016/j.bbrc.2023.149132. Online ahead of print. No abstract available.

    PMID: 39492324BACKGROUND

  • Petersen Williams P, Erasmus J, Myers B, Nadkarni A, Fuhr DC. Community-based counselling programme for pregnant women with alcohol problems in Cape Town, South Africa: a qualitative study of the views of pregnant women and healthcare professionals. Front Psychiatry. 2023 Jul 6;14:1203835. doi: 10.3389/fpsyt.2023.1203835. eCollection 2023.

    PMID: 37484680BACKGROUND

MeSH Terms

Conditions

Alcoholism

Interventions

EthanolPregnancyMethods

Condition Hierarchy (Ancestors)

Alcohol-Related DisordersSubstance-Related DisordersChemically-Induced DisordersMental Disorders

Intervention Hierarchy (Ancestors)

AlcoholsOrganic ChemicalsReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological PhenomenaInvestigative Techniques

Study Officials

  • Daniela C Fuhr, Prof.

    Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH

    PRINCIPAL INVESTIGATOR

  • Patel Peterson Williams, Prof.

    Medical Research Council, South Africa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
This study employs single-blind masking, where participants and intervention providers (community health workers) are aware of group assignments. Data collectors and assessors conducting follow-up evaluations are blinded to treatment allocation. This ensures objective data collection and reduces potential observer bias in outcome assessments. To maintain blinding, assessors will not be involved in intervention delivery and will not have access to participant allocation records.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The study follows a parallel-arm, individually randomized controlled trial (RCT) design to assess the feasibility, acceptability, and preliminary effectiveness of the Counselling for Alcohol Problems in Pregnancy (CAP-Pre) intervention. Participants (n=40 pregnant women, ≤28 weeks gestation) will be randomly assigned (1:1) to either: Intervention Group: CAP-Pre plus Enhanced Usual Care (EUC), consisting of five manualized counselling sessions delivered by trained community health workers (CHWs). Control Group: EUC only, including an information booklet on alcohol use in pregnancy but no structured counselling. Primary outcomes focus on alcohol consumption, measured via self-report (TLFB). Secondary outcomes assess biomarkers for alcohol consumption PeTH testing, psychosocial functioning (WHO-DAS), depressive symptoms (EPDS), alcohol-related consequences (AUDIT-C) and perceived usefulness (qualitative interviews). Data will be collected at baseline and intervention
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 3, 2025

Study Start

February 10, 2025

Primary Completion

May 1, 2025

Study Completion

July 1, 2025

Last Updated

March 3, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

The data is subject to strict confidentiality agreements as per the ethical approval obtained, and sharing it publicly could compromise participant privacy.

Locations

ZA(1)