Clinical trial NCT06853873: Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II
Official title: Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Alcohol Use Disorder
Keywords: Alcohol misuse
pregnancy
Women
Psychoeducation
Lay Health Workers
South Africa
Alcohol use in Pregnancy
Counseling Sessions
Psychoeducational Intervention
Lead sponsor: Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
Sponsor class: OTHER
Collaborators: name: Technical University of Munich
name: Medical Research Council, South Africa
First posted: 2025-03-03
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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. 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.

Detailed description: South Africa has the highest prevalence of Fetal Alcohol Spectrum Disorders (FASD) globally, with alcohol use during pregnancy being prevalent in low-resource settings. However, there is no structured, community-based psychological support available for pregnant women who consume alcohol at harmful levels. The Counselling for Alcohol Problems in Pregnancy (CAP-Pre) intervention is a brief psychological counseling program designed to:

* Support pregnant women in reducing alcohol use through motivational interviewing (MI) and cognitive-behavioral techniques (CBT).
* Improve maternal well-being by addressing underlying stressors and barriers to change.
* Be delivered by community health workers (CHWs) in a scalable, task-shifted approach.

This pilot randomized controlled trial (RCT) aims to evaluate the CAP-Pre intervention's perceived effectiveness, feasibility, and acceptability in preparation for a definitive RCT.

Study Design Type: Parallel-arm, single-blind, individually randomized controlled trial (RCT).

Setting: Community-based antenatal care program, Cape Flats, Western Cape, South Africa.

Participants: 40 pregnant women screened for the following eligibility criteria

Inclusion:

* ≥18 years old, ≤28 weeks pregnant.
* AUDIT score 8-20 (indicating hazardous alcohol use).

Exclusion:

* Severe psychiatric disorders.
* High-risk pregnancy complications. Recruitment Sites: Community outreach and antenatal clinics.

Randomization: 1:1 allocation to:

* CAP-Pre + Enhanced Usual Care (EUC) (Intervention)
* Enhanced Usual Care (EUC) only (Control) Intervention and Control Groups Intervention: CAP-Pre + Enhanced Usual Care (EUC) (n=20) 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. Control: Enhanced Usual Care (EUC) (n=20) Information booklet on alcohol use in pregnancy. Referral to antenatal services if needed. No structured counseling was provided.

Data Collection and Outcome Measures

Data Collection Timeline:

Baseline assessment before randomization and Post-intervention assessment on alcohol use, mental health, and qualitative feedback Primary Outcomes

Reduction in alcohol consumption measured through:

Self-Reported Alcohol Use: Alcohol consumption will be assessed using the Alcohol Timeline Follow Back (TLFB) method to estimate daily drinking volume over the past months.

Secondary Outcomes

1. Biological Markers for alcohol consumption: Phosphatidyl ethanol (PeTH) through Dried Blood Spot (DBS) Collection. PeTH is a direct biomarker of alcohol consumption that is formed only in the presence of ethanol. It is highly specific and sensitive in detecting alcohol use over the past 2-3 weeks.
2. Psychosocial Functioning: Assessed using the WHO-Disability Assessment Schedule (WHO-DAS). WHO-DAS 2.0 is a standardized instrument developed by the World Health Organization (WHO) to assess functional impairment and disability across multiple life domains. It evaluates the impact of mental and physical health conditions on daily activities and social participation.
3. Depressive Symptoms: Evaluated using the Edinburgh Postnatal Depression Scale (EPDS). EPDS is a 10-item self-report measure designed to screen for perinatal depression in pregnant and postpartum women.
4. Alcohol-Related Consequences: Measured with the Alcohol Use Disorder Identification Test - Consumption (AUDIT-C). AUDIT-C is a brief, 3-item screening tool derived from the full 10-item Alcohol Use Disorders Identification Test (AUDIT) to identify individuals at risk for hazardous drinking and alcohol use disorders (AUDs).
5. Family and Social Support: Assessed using a 10-item structured questionnaire measuring the availability and perceived adequacy of social support across various domains, such as emotional, instrumental, and informational support.
6. Perceived Usefulness of Counselling: Evaluated through qualitative pre and post-intervention interviews, exploring participant expectations, experiences, perceptions of counseling, and perceived benefits or challenges.

Baseline Covariates:

Additional Covariates Collected at Baseline

1. Demographic and Socioeconomic Information: Age, education, and socioeconomic status.
2. Substance Use and Risk Factors: Self-reported past-month use of tobacco and other substances.
3. Partner Substance Use: Self-reported data on household and partner alcohol/drug use.
4. Intimate Partner Violence (IPV) \& History of Trauma: Self-reported experiences of violence, abuse, and health-related risks.
5. Childhood Adversity and Life Stressors: Self-reported early trauma and current stressors.

Analysis Plan We will analyze and report data following CONSORT guidelines for pilot and feasibility trials. Analyses for the pilot RCT will mainly be descriptive to describe recruitment and response rates, process data, and retention at 3 months.

Ethical Considerations This study poses minimal risks, including minor discomfort from blood sampling and potential mental distress during sessions. Confidentiality will be protected through strict data security, staff confidentiality agreements, and ethical training. PeTH blood collection will follow infection control protocols and be conducted by trained staff. Mental distress risks will be minimized through participant choice, referrals for support, and staff supervision. The study has ethical approval from the South African MRC, and participation is voluntary, with the right to withdraw at any time.

Output A contextually adapted program of care (called CAP-PRE) for pregnant women who misuse alcohol that can be tested for effectiveness and cost-effectiveness in a larger, definitive RCT.

Eligibility criteria: Inclusion Criteria:

* • 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Self-Reported Alcohol Consumption assessed using the Alcohol Timeline Follow Back (TLFB)
timeFrame: Changes from Baseline to Post Intervention in 6 weeks
Secondary outcomes:
measure: Biological Marker of Alcohol Use assessed using Phosphatidylethanol (PeTH) testing
timeFrame: Changes from Baseline to Post Intervention in 6 weeks
measure: Psychosocial functioning assessed using WHO-Disability Assessment Schedule (WHO-DAS)
timeFrame: Changes from Baseline to Post Intervention in 6 weeks
measure: Depressive Symptoms assessed using Edinburgh Postnatal Depression Scale (EPDS)
timeFrame: Changes from Baseline to Post Intervention in 6 weeks
measure: Alcohol-Related Consequences assessed using Alcohol Use Disorder Identification Test - Consumption (AUDIT-C)
timeFrame: Changes from Baseline to Post Intervention in 6 weeks
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: South African Medical Research Council (SAMRC)
Study officials:
affiliation: Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH
name: Daniela C Fuhr, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Medical Research Council, South Africa
name: Patel Peterson Williams, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.