MaRISA+: Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention 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
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
|
| Active Comparator: Usual Care Community treatment referrals |
Behavioral: Intervention with contingent incentives and text-based support
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
|
Outcome Measures
Primary Outcome Measures
- Urinalysis for an alcohol metabolite (EtG) [3-month postpartum]
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
- Urinalysis for cotinine [3-month postpartum]
Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking.
- Urinalysis for cannabis metabolite (THC) [3-month postpartum]
Dichotomous positive results of cannabis use by urinalysis will be considered positive for recent cannabis use.
- Blood analysis of alcohol metabolite (PEth) [3-month postpartum]
Dichotomous positive results of alcohol use by blood test will be considered positive for recent drinking.
- Self-reported use on alcohol use [3-month postpartum]
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"]).
- Self-reported use on tobacco use [3-month postpartum]
Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette).
- Self-reported use on cannabis use [3-month postpartum]
Self-reported use of daily tobacco by the number of cones/joints/pipes.
- Self-reported use while breastfeeding on alcohol use [3-month postpartum]
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"]).
- Self-reported use while breastfeeding on tobacco use [3-month postpartum]
Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette).
- Self-reported use while breastfeeding on cannabis use [3-month postpartum]
Self-reported use of daily tobacco by the number of cones/joints/pipes.
Secondary Outcome Measures
- Gestational incidents [during pregnancy (up to week 40) and at birth]
Gestational hypertension, gestational diabetes, or preeclampsia incidents
- Infant weight (g) outcomes [during 3-month postpartum]
The measure will be based on medical records and postpartum assessment.
- Infant height (cm) [during 3-month postpartum]
he measure will be based on medical records and postpartum assessment.
- Infant head circumference (cm) [during 3-month postpartum]
The measure will be based on medical records.
- Gestational weeks at birth [at birth]
The measure will be based on medical records.
Eligibility Criteria
Criteria
Inclusion Criteria:
For key informant interviews in R61
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be pregnant or breastfeeding with less than 12 months postpartum,
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test positive in alcohol use by urinalysis (i.e., EtG),
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test positive in tobacco or cannabis use by urinalysis (i.e., cotinine and Delta-9-tetrahydrocannabinol [THC]),
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be Black African or Coloured,
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have a negative HIV test,
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not be eligible for pre-exposure prophylaxis (PrEP).
For testing in R61,
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be in the second trimester of pregnancy or breastfeeding with less than 1 month postpartum,
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test positive in alcohol use by urinalysis (i.e., EtG),
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test positive in tobacco or cannabis use by urinalysis (i.e., cotinine and THC),
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be Black African or Coloured,
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have a negative HIV test,
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not be eligible for PrEP,
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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.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- RTI International
- Medical Research Council, South Africa
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- EC025-11/2022