Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05747599
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-28
First Post:
2023-01-30
Brief Title:
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Sponsor:
RTI International
Organization:
RTI International
Study Overview
Official Title:
Adapting and Testing a Behavioural Intervention to Prevent FASD and Adverse Infant Outcomes
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MaRISA
Brief Summary:
South Africa SA has a long history of social and health disparities resulting in the worlds highest rate of fetal alcohol spectrum disorder FASD 1111 per 1000 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 breastfeedingmaternal 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 US The Womens 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 ie 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
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 breastfeedingmaternal 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 US The Womens 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 ie 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None