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

NCT05747599 | Completed Results DMC

• 1 other identifier: EC025-11/2022
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Maternal Behavior; Alcohol Drinking; Fetal Conditions

Outcome Measures

Primary Outcomes (6)

• Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG)

  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.

  3-month postpartum

• Number of Participants With Negative Urinalysis for Nicotine Metabolite (Cotinine)

  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.

  3-month postpartum

• Number of Participants With Negative Urinalysis for Cannabis Metabolite (THC)

  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.

  3-month postpartum

• Number of Days in the Past 7-day Alcohol Use

  The number of days in the past 7 days that participants used alcohol.

  3-month postpartum

• Number of Days in the Past 7-day Tobacco Use

  The number of days in the past 7 days that participants used tobacco.

  3-month postpartum

• Number of Days in the Past 7-day Cannabis Use

  The number of days in the past 7 days that participants used cannabis.

  3-month postpartum

Secondary Outcomes (3)

• Number of Days in the Past 7-day Cannabis Use While Breastfeeding

  3-month postpartum

• Number of Days in the Past 7-day Tobacco Use While Breastfeeding

  3-month postpartum

• Number of Days in the Past 7-day Alcohol Use While Breastfeeding

  3-month postpartum

Other Outcomes (4)

• Birth Weight (g)

  at birth

• Birth Length (cm)

  at birth

• Gestational Age (Weeks)

  at birth

Study Arms (2)

Intervention

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

Community treatment referrals

Behavioral: Intervention with contingent incentives and text-based support

Interventions

Intervention with contingent incentives and text-based support BEHAVIORAL

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

Intervention; Usual Care

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- (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.

Sponsors & Collaborators

• RTI International: lead
• Medical Research Council, South Africa: collaborator

Study Sites (1)

South African Medical Research Council

Cape Town, South Africa

Location

MeSH Terms

Conditions

Alcohol Drinking

Interventions

Methods

Condition Hierarchy (Ancestors)

Drinking Behavior; Behavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

• Title: Yukiko Washio, PhD
• Organization: RTIInternational

ywashio@rti.org

9194852794

Study Officials

• Yukiko Washio, PhD

  RTI International

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 30, 2023
• First Posted: February 28, 2023
• Study Start: April 1, 2023
• Primary Completion: September 10, 2024
• Study Completion: October 31, 2024
• Last Updated: February 28, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR

Locations

ZA (1)