Maternal BehaviorMaRISA+NCT05747599
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
A study testing Intervention with contingent incentives and text-based support in people with Maternal Behavior and Alcohol Drinking, run by RTI International at 1 site in South Africa.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Maternal Behavior, Alcohol Drinking, Fetal Conditions
- What is being tested?
- Intervention with contingent incentives and text-based support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Apr 2023to 31 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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.
Who cannot join
- (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.
- Women who participated in interviews.
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Intervention with contingent incentives and text-based support
- Medical subject headings
- Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with contingent incentives and text-based supportBehavioural
Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Contingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components Receives: Behavioral: Intervention with contingent incentives and text-based support |
| Usual Care | Active comparator | Community treatment referrals Receives: Behavioral: Intervention with contingent incentives and text-based support |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3-month postpartum
Secondary outcomes (3)
Number of Days in the Past 7-day Cannabis Use While Breastfeeding
The number of days in the past 7 days that participants used cannabis while breastfeeding.
Measured: 3-month postpartum
Number of Days in the Past 7-day Tobacco Use While Breastfeeding
The number of days in the past 7 days that participants used tobacco while breastfeeding.
Measured: 3-month postpartum
Number of Days in the Past 7-day Alcohol Use While Breastfeeding
The number of days in the past 7 days that participants used alcohol while breastfeeding.
Measured: 3-month postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start1 Apr 2023
- Primary completion10 Sep 2024
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Maternal BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- RTI International
- Sponsor type
- University, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Responsible party
- Principal investigator, Yukiko Washio, RTI International
- Investigators
- Yukiko Washio, PhD, Principal investigator, RTI International
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05747599
- Sponsor's protocol ID
- EC025-11/2022
- Acronym
- MaRISA+
- Status last verified
- Feb 2025
- First submitted
- 30 Jan 2023
- Last updated
- 28 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
- ClinicalTrials.gov ID
- NCT05747599
- Acronym / sponsor ID
- MaRISA+ / EC025-11/2022
- Conditions
- Maternal Behavior, Alcohol Drinking, Fetal Conditions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- RTI InternationalUniversity, hospital or other
- Collaborators
- Medical Research Council, South Africa
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 10 Sep 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 28 Feb 2023 (actual)
- Results
- Posted 10 Feb 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Intervention with contingent incentives and text-based supportContingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components |
| Usual Care | Active comparator | Behavioral: Intervention with contingent incentives and text-based supportCommunity treatment referrals |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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),
Key exclusion criteria (2 listed)
- (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.
- Women who participated in interviews.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with contingent incentives and text-based supportContingent incentives on abstinence from alcohol, tobacco, and cannabis; Text-based support based on educational components | Behavioural | Intervention, Usual Care |
Primary outcome
Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG)
Time frame: 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)
Time frame: 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 Participants With Negative Urinalysis for Cannabis Metabolite (THC)
Time frame: 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 Days in the Past 7-day Alcohol Use
Time frame: 3-month postpartum
The number of days in the past 7 days that participants used alcohol.
Number of Days in the Past 7-day Tobacco Use
Time frame: 3-month postpartum
The number of days in the past 7 days that participants used tobacco.
Number of Days in the Past 7-day Cannabis Use
Time frame: 3-month postpartum
The number of days in the past 7 days that participants used cannabis.
3 secondary outcomes
Number of Days in the Past 7-day Cannabis Use While Breastfeeding
Time frame: 3-month postpartum
Number of Days in the Past 7-day Tobacco Use While Breastfeeding
Time frame: 3-month postpartum
Number of Days in the Past 7-day Alcohol Use While Breastfeeding
Time frame: 3-month postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. After the main findings are published, we welcome other researchers who want to analyze the data in other ways.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yukiko Washio, PhD principal investigator
RTI International
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with contingent incentives and text-based support in people with Maternal Behavior and Alcohol Drinking, run by RTI International at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Negative Urinalysis for Alcohol Metabolite (EtG) (time frame: 3-month postpartum). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2025.