Counseling for Alcohol Problems in Pregnancy (CAP-Pre) Phase II
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Self-Reported Alcohol Consumption assessed using the Alcohol Timeline Follow Back (TLFB)
研究概览
简要总结
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:
- CAP-Pre + Standard Health Advice - Women will receive five counseling sessions to help them reduce drinking, plus usual pregnancy care.
- 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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •• Pregnant women ≤28 weeks gestation.
- •Alcohol Use Risk: Hazardous alcohol use, defined as an Alcohol Use Disorder Identification Test (AUDIT) score of 8-
- •Age ≥18 years old at the time of recruitment.
- •Consent: Ability to provide written informed consent and willingness to participate in the study
排除标准
- •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.
研究组 & 干预措施
Enhanced Usual Care (EUC)
Information booklet on alcohol use in pregnancy. Referral to antenatal services if needed. No structured counseling was provided.
CAP-Pre + Enhanced Usual Care
The Counselling for Alcohol Problems in Pregnancy (CAP-Pre) intervention
干预措施: The Counselling for Alcohol Problems in Pregnancy (CAP-Pre) intervention (Behavioral)
结局指标
主要结局
Self-Reported Alcohol Consumption assessed using the Alcohol Timeline Follow Back (TLFB)
时间窗: Changes from Baseline to Post Intervention in 6 weeks
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.
次要结局
- Depressive Symptoms assessed using Edinburgh Postnatal Depression Scale (EPDS)(Changes from Baseline to Post Intervention in 6 weeks)
- 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)
- Alcohol-Related Consequences assessed using Alcohol Use Disorder Identification Test - Consumption (AUDIT-C)(Changes from Baseline to Post Intervention in 6 weeks)
研究者
Daniela C. Fuhr
Prof
Leibniz Institute for Prevention Research and Epidemiology - BIPS GmbH