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

Alcohol Drinking Clinical Trial

— MaRISA+  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05747599
• Other study ID #: EC025-11/2022
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: August 31, 2024

Study information

• Verified date: July 2023
• Source: RTI International
• Contact: Yukiko Washio, PhD
• Phone: 9194852794
• Email: ywashio[@]rti.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 112
• Est. completion date: August 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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,

1. be in the second trimester of pregnancy or breastfeeding with less than 1 month postpartum,

2. test positive in alcohol use by urinalysis (i.e., EtG),

3. test positive in tobacco or cannabis use by urinalysis (i.e., cotinine and THC),

4. have a negative HIV test,

5. 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.

Related Conditions & MeSH terms

• Alcohol Drinking
• Fetal Conditions
• Maternal Behavior

Intervention

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

Locations

Country	Name	City	State
South Africa	South African Medical Research Council	Cape Town

Sponsors (2)

Lead Sponsor	Collaborator
RTI International	Medical Research Council, South Africa

Country where clinical trial is conducted

South Africa, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urinalysis for an alcohol metabolite (EtG)	Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.	3-month postpartum
Primary	Urinalysis for cotinine	Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking.	3-month postpartum
Primary	Urinalysis for cannabis metabolite (THC)	Dichotomous positive results of cannabis use by urinalysis will be considered positive for recent cannabis use.	3-month postpartum
Primary	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
Primary	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
Primary	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
Primary	Self-reported use on cannabis use	Self-reported use of daily tobacco by the number of cones/joints/pipes.	3-month postpartum
Primary	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
Primary	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
Primary	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	Gestational incidents	Gestational hypertension, gestational diabetes, or preeclampsia incidents	during pregnancy (up to week 40) and at birth
Secondary	Infant weight (g) outcomes	The measure will be based on medical records and postpartum assessment.	during 3-month postpartum
Secondary	Infant height (cm)	he measure will be based on medical records and postpartum assessment.	during 3-month postpartum
Secondary	Infant head circumference (cm)	The measure will be based on medical records.	during 3-month postpartum
Secondary	Gestational weeks at birth	The measure will be based on medical records.	at birth