- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05747599
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes (MaRISA+)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Yukiko Washio, PhD
- Phone Number: 9194852794
- Email: ywashio@rti.org
Study Locations
-
-
-
Cape Town, South Africa
- Recruiting
- South African Medical Research Council
-
Contact:
- Petal Petersen Williams, PhD
- Phone Number: +27-21-938-0337
- Email: petal.petersen@mrc.ac.za
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
|
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
|
Active Comparator: Usual Care
Community treatment referrals
|
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinalysis for an alcohol metabolite (EtG)
Time Frame: 3-month postpartum
|
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
|
3-month postpartum
|
Urinalysis for cotinine
Time Frame: 3-month postpartum
|
Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking.
|
3-month postpartum
|
Urinalysis for cannabis metabolite (THC)
Time Frame: 3-month postpartum
|
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)
Time Frame: 3-month postpartum
|
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
Time Frame: 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"]).
|
3-month postpartum
|
Self-reported use on tobacco use
Time Frame: 3-month postpartum
|
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
Time Frame: 3-month postpartum
|
Self-reported use of daily tobacco by the number of cones/joints/pipes.
|
3-month postpartum
|
Self-reported use while breastfeeding on alcohol use
Time Frame: 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"]).
|
3-month postpartum
|
Self-reported use while breastfeeding on tobacco use
Time Frame: 3-month postpartum
|
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
Time Frame: 3-month postpartum
|
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
Time Frame: during pregnancy (up to week 40) and at birth
|
Gestational hypertension, gestational diabetes, or preeclampsia incidents
|
during pregnancy (up to week 40) and at birth
|
Infant weight (g) outcomes
Time Frame: during 3-month postpartum
|
The measure will be based on medical records and postpartum assessment.
|
during 3-month postpartum
|
Infant height (cm)
Time Frame: during 3-month postpartum
|
he measure will be based on medical records and postpartum assessment.
|
during 3-month postpartum
|
Infant head circumference (cm)
Time Frame: during 3-month postpartum
|
The measure will be based on medical records.
|
during 3-month postpartum
|
Gestational weeks at birth
Time Frame: at birth
|
The measure will be based on medical records.
|
at birth
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Yukiko Washio, PhD, RTI International
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EC025-11/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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