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

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.

• Biological Marker of Alcohol Use assessed using Phosphatidylethanol (PeTH) testing [Срок оценки: Changes from Baseline to Post Intervention in 6 weeks]
• Psychosocial functioning assessed using WHO-Disability Assessment Schedule (WHO-DAS) [Срок оценки: Changes from Baseline to Post Intervention in 6 weeks]
• Depressive Symptoms assessed using Edinburgh Postnatal Depression Scale (EPDS) [Срок оценки: Changes from Baseline to Post Intervention in 6 weeks]
• Alcohol-Related Consequences assessed using Alcohol Use Disorder Identification Test - Consumption (AUDIT-C) [Срок оценки: Changes from Baseline to Post Intervention in 6 weeks]