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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05747599

Acronym

MaRISA+

Enrollment

Registered

2023-02-28

Start date

2023-04-01

Completion date

2024-10-31

Last updated

2025-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alcohol Drinking, Fetal Conditions, Maternal Behavior

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.

Interventions

BEHAVIORALIntervention with contingent incentives and text-based support

Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Yes

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 3 months 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. be over 18 years old 5. have a negative HIV test, 6. not be eligible for PrEP 7. plan to complete antenatal care at the current clinic and remain in the area for at least 3 months 8. own a cell phone to receive text messages.

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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC)	3-month postpartum	Biochemical verification of recent cannabis use in urine samples. A cannabis metabolite (THC) will be measured in urine samples. The metabolite can be detected up to 28 days after heavy use. The dipstick testing will have ≥50 ng/mL as a cutoff value.
Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG)	3-month postpartum	An alcohol metabolite (EtG) will be measured in urine samples. EtG can be detected in the urine up to 5 days after heavy drinking and up to 2 days after light drinking. The dipstick testing will have ≥300 ng/mL as a cutoff value.
Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine)	3-month postpartum	Biochemical verification of recent tobacco use in urine samples. A tobacco metabolite (cotinine) will be measured in urine samples. The metabolite can be detected up to 3-4 days after use. The dipstick testing will have ≥200 ng/mL as a cutoff value.
Number of Days in the Past 7-day Alcohol Use	3-month postpartum	The number of days in the past 7 days that participants used alcohol.
Number of Days in the Past 7-day Cannabis Use	3-month postpartum	The number of days in the past 7 days that participants used cannabis.
Number of Days in the Past 7-day Tobacco Use	3-month postpartum	The number of days in the past 7 days that participants used tobacco.

Secondary

Measure	Time frame	Description
Number of Days in the Past 7-day Alcohol Use While Breastfeeding	3-month postpartum	The number of days in the past 7 days that participants used alcohol while breastfeeding.
Number of Days in the Past 7-day Cannabis Use While Breastfeeding	3-month postpartum	The number of days in the past 7 days that participants used cannabis while breastfeeding.
Number of Days in the Past 7-day Tobacco Use While Breastfeeding	3-month postpartum	The number of days in the past 7 days that participants used tobacco while breastfeeding.

Other

Measure	Time frame	Description
Birth Weight (g)	at birth	birth weight of infants among participants who entered the study during pregnancy
Head Circumference (cm)	at birth	Head circumference of infants among participants who entered the study during pregnancy
Gestational Age (Weeks)	at birth	Gestational age of infants among participants who entered the study during pregnancy
Birth Length (cm)	at birth	birth length of infants among participants who entered the study during pregnancy

Countries

South Africa

Participant flow

Participants by arm

Arm	Count
Contingent Incentives + Text-based Support Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components Intervention with contingent incentives and text-based support: Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components	48
Total	48

Baseline characteristics

Characteristic	Contingent Incentives + Text-based Support
Age, Continuous	30 years STANDARD_DEVIATION 6
Education 12 years or less	44 Participants
Education More than 12 years	4 Participants
Marital Status Living with a partner	19 Participants
Marital Status Married	9 Participants
Marital Status Not living with a partner	16 Participants
Marital Status Others	4 Participants
Race/Ethnicity, Customized Black	17 Participants
Race/Ethnicity, Customized Mixed	31 Participants
Sex: Female, Male Female	48 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 48
other Total, other adverse events	2 / 48
serious Total, serious adverse events	2 / 48