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Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes (MaRISA+)

Primary Purpose

Maternal Behavior, Alcohol Drinking, Fetal Conditions

Status
Recruiting
Phase
Not Applicable
Locations
South Africa
Study Type
Interventional
Intervention
Intervention with contingent incentives and text-based support
Sponsored by
RTI International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Maternal Behavior

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • South African Medical Research CouncilRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention

Usual Care

Arm Description

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

Community treatment referrals

Outcomes

Primary Outcome Measures

Urinalysis for an alcohol metabolite (EtG)
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Urinalysis for cotinine
Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking.
Urinalysis for cannabis metabolite (THC)
Dichotomous positive results of cannabis use by urinalysis will be considered positive for recent cannabis use.
Blood analysis of alcohol metabolite (PEth)
Dichotomous positive results of alcohol use by blood test will be considered positive for recent drinking.
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"]).
Self-reported use on tobacco use
Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette).
Self-reported use on cannabis use
Self-reported use of daily tobacco by the number of cones/joints/pipes.
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"]).
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).
Self-reported use while breastfeeding on cannabis use
Self-reported use of daily tobacco by the number of cones/joints/pipes.

Secondary Outcome Measures

Gestational incidents
Gestational hypertension, gestational diabetes, or preeclampsia incidents
Infant weight (g) outcomes
The measure will be based on medical records and postpartum assessment.
Infant height (cm)
he measure will be based on medical records and postpartum assessment.
Infant head circumference (cm)
The measure will be based on medical records.
Gestational weeks at birth
The measure will be based on medical records.

Full Information

First Posted
January 30, 2023
Last Updated
July 4, 2023
Sponsor
RTI International
Collaborators
Medical Research Council, South Africa
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1. Study Identification

Unique Protocol Identification Number
NCT05747599
Brief Title
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Acronym
MaRISA+
Official Title
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
RTI International
Collaborators
Medical Research Council, South Africa

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maternal Behavior, Alcohol Drinking, Fetal Conditions

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
112 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
Community treatment referrals
Intervention Type
Behavioral
Intervention Name(s)
Intervention with contingent incentives and text-based support
Intervention Description
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
Primary Outcome Measure Information:
Title
Urinalysis for an alcohol metabolite (EtG)
Description
Dichotomous positive results of alcohol use by urinalysis will be considered positive for recent drinking.
Time Frame
3-month postpartum
Title
Urinalysis for cotinine
Description
Dichotomous positive results of tobacco use by urinalysis will be considered positive for recent smoking.
Time Frame
3-month postpartum
Title
Urinalysis for cannabis metabolite (THC)
Description
Dichotomous positive results of cannabis use by urinalysis will be considered positive for recent cannabis use.
Time Frame
3-month postpartum
Title
Blood analysis of alcohol metabolite (PEth)
Description
Dichotomous positive results of alcohol use by blood test will be considered positive for recent drinking.
Time Frame
3-month postpartum
Title
Self-reported use on alcohol use
Description
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"]).
Time Frame
3-month postpartum
Title
Self-reported use on tobacco use
Description
Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette).
Time Frame
3-month postpartum
Title
Self-reported use on cannabis use
Description
Self-reported use of daily tobacco by the number of cones/joints/pipes.
Time Frame
3-month postpartum
Title
Self-reported use while breastfeeding on alcohol use
Description
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"]).
Time Frame
3-month postpartum
Title
Self-reported use while breastfeeding on tobacco use
Description
Self-reported use of daily tobacco by the number of the number of puffs (8 puffs = 1 cigarette).
Time Frame
3-month postpartum
Title
Self-reported use while breastfeeding on cannabis use
Description
Self-reported use of daily tobacco by the number of cones/joints/pipes.
Time Frame
3-month postpartum
Secondary Outcome Measure Information:
Title
Gestational incidents
Description
Gestational hypertension, gestational diabetes, or preeclampsia incidents
Time Frame
during pregnancy (up to week 40) and at birth
Title
Infant weight (g) outcomes
Description
The measure will be based on medical records and postpartum assessment.
Time Frame
during 3-month postpartum
Title
Infant height (cm)
Description
he measure will be based on medical records and postpartum assessment.
Time Frame
during 3-month postpartum
Title
Infant head circumference (cm)
Description
The measure will be based on medical records.
Time Frame
during 3-month postpartum
Title
Gestational weeks at birth
Description
The measure will be based on medical records.
Time Frame
at birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yukiko Washio, PhD
Phone
9194852794
Email
ywashio@rti.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yukiko Washio, PhD
Organizational Affiliation
RTI International
Official's Role
Principal Investigator
Facility Information:
Facility Name
South African Medical Research Council
City
Cape Town
Country
South Africa
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Petal Petersen Williams, PhD
Phone
+27-21-938-0337
Email
petal.petersen@mrc.ac.za

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
After the main findings are published, we welcome other researchers who want to analyze the data in other ways.

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

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