Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes

Study Overview
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Brief Summary
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South Africa (SA) has a long history of social and health disparities, resulting in the world's highest rate of fetal alcohol spectrum disorder (FASD; 111.1 per 1,000), where lifelong negative cognitive and physical effects result from prenatal alcohol exposure. FASD is completely preventable if women do not drink during pregnancy. Prenatal alcohol use frequently co-occurs with other substance use, especially tobacco and cannabis. The adverse effect on birth outcomes by alcohol and tobacco use together is worse than either substance alone. Recent evidence from animal models shows that prenatal exposure to both cannabinoids and alcohol potentiate the likelihood of alcohol-induced birth defects. Data from Cape Metropole, SA, showed that all women who reported prenatal alcohol use also tested positive for tobacco use, with 25% also reporting cannabis use. Alcohol use while breastfeeding also occurs at a relatively high rate in SA. Despite tremendous health benefits from breastfeeding,maternal alcohol use while breastfeeding significantly compromises infant development. Contingency management (CM) has been efficacious in reducing prenatal cocaine, alcohol, and tobacco use in the United States (U.S.). The Women's Health CoOp (WHC) is an evidence-based brief intervention addressing women-focused syndemic issues and resulting disparities associated with substance and alcohol use. These evidence-based interventions need to be combined and adapted for addressing maternal polysubstance use and associated health and behavioral issues during pregnancy and lactation in SA. The Specific Aims are as follows: (1) R61 Aim 1- Conduct formative qualitative research with women who are pregnant or breastfeeding with a recent history of polysubstance use, clinic and community stakeholders, and an established Community Collaborative Board. (2) R61 Aim 2-Test feasibility, acceptability, and appropriateness of the adapted intervention with 48 women (24 pregnant and 24 breastfeeding) in Cape Metropole, SA. (3) R33 Aim 1-Examine the effectiveness of the adapted intervention (i.e., CM and text-based support with WHC educational components) in a 2-group randomized controlled trial with 184 women who are pregnant and follow up during pregnancy and 3 months postpartum. (4) R33 Aim 2-Examine the impact on gestational, birth, and infant outcomes. (5) R33 Aim 3-Track cost and conduct preliminary cost-effectiveness analyses.

Official Title
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Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes

Conditions
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Maternal Behavior, Alcohol Drinking, Fetal Conditions

Intervention / Treatment
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* Behavioral: Intervention with contingent incentives and text-based support


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: For key informant interviews in R61 To be eligible, women must (1) 18 or older, (2) be pregnant or breastfeeding with less than 12 months postpartum, (3) report alcohol use , (4) report tobacco or cannabis use For testing in R61, be in the second trimester of pregnancy or breastfeeding with less than 1 month postpartum, test positive in alcohol use by urinalysis (i.e., EtG), test positive in tobacco or cannabis use by urinalysis (i.e., cotinine and THC), have a negative HIV test, plan to complete antenatal care at the current clinic and remain in the area for at least 3 months. Exclusion Criteria: - (1) women who report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month. These women will be provided necessary referrals. (2) Women who participated in interviews.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components | Behavioral: Intervention with contingent incentives and text-based support<br>* Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components<br>|
| Active Comparator: Usual Care<br>Community treatment referrals | Behavioral: Intervention with contingent incentives and text-based support<br>* Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinalysis for an alcohol metabolite (EtG) | Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking. | 3-month postpartum | 
| Urinalysis for cotinine | Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking. | 3-month postpartum | 
| Urinalysis for cannabis metabolite (THC) | Dichotomous positive results of cannabis use by urinalysis will be considered positive for recent cannabis use. | 3-month postpartum | 
| Blood analysis of alcohol metabolite (PEth) | Dichotomous positive results of alcohol use by blood test will be considered positive for recent drinking. | 3-month postpartum | 
| Self-reported use on alcohol use | Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink) and craving levels on a scale of 1 to 10 [not at all to extreme]). | 3-month postpartum | 
| Self-reported use on tobacco use | Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette). | 3-month postpartum | 
| Self-reported use on cannabis use | Self-reported use of daily tobacco by the number of cones/joints/pipes. | 3-month postpartum | 
| Self-reported use while breastfeeding on alcohol use | Self-reported use of daily alcohol by the number of standard drinks based on the definition in South Africa (e.g., 12 g per standard drink) and craving levels on a scale of 1 to 10 [not at all to extreme]). | 3-month postpartum | 
| Self-reported use while breastfeeding on tobacco use | Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette). | 3-month postpartum | 
| Self-reported use while breastfeeding on cannabis use | Self-reported use of daily tobacco by the number of cones/joints/pipes. | 3-month postpartum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational incidents | Gestational hypertension, gestational diabetes, or preeclampsia incidents | during pregnancy (up to week 40) and at birth | 
| Infant weight (g) outcomes | The measure will be based on medical records and postpartum assessment. | during 3-month postpartum | 
| Infant height (cm) | he measure will be based on medical records and postpartum assessment. | during 3-month postpartum | 
| Infant head circumference (cm) | The measure will be based on medical records. | during 3-month postpartum | 
| Gestational weeks at birth | The measure will be based on medical records. | at birth |