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FASD Prevention R33 (R33)

14 september 2026 uppdaterad av: Yukiko Washio, Philadelphia College of Osteopathic Medicine

Adapting and Testing Behavioral Intervention to Prevent Fetal Alcohol Spectrum Disorders and Adverse Infant Outcomes (R33)

This R33 application proposes to adapt and test an evidence-based behavioral intervention to decrease polysubstance use (i.e., alcohol and tobacco/cannabis) during pregnancy and lactation and prevent adverse clinical outcomes, including fetal alcohol spectrum disorder (FASD) in South Africa (SA). SA has a long history of social and health disparities, resulting in the world's highest rate of 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Beräknad)

184

Fas

  • Fas 2

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Sydafrika
      • Cape Town, Sydafrika
        • University of Cape Town
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Beskrivning

Inclusion Criteria:

  • (1) be pregnant, (2) intend to breastfeed, (3) test positive for alcohol use by urinalysis (i.e., EtG), (4) test positive for tobacco or cannabis use by urinalysis (i.e., cotinine and THC), (5) have an independent access to a mobile phone, (6) plan to remain in the area during pregnancy and 3 months postpartum.

Exclusion Criteria:

  • Report serious medical problems threatening their current pregnancy or current suicidal thoughts or attempts in the past month.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Förebyggande
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: Usual Care
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Beteende: Usual Care
Participants will receive community referrals to treatment programs as needed and will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample and fill out timeline follow-back. R200 will be provided for sample provision. Research staff will make referrals to treatment programs in the community as needed.
Experimentell: Intervention
Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.
Beteende: Intervention
Participants will receive text-based support on health promotion and referral content based on educational components. Participants will be asked to meet research staff on a monthly basis at the clinic to provide a urine sample, fill out timeline follow back on self-reported alcohol and tobacco/cannabis use, and receive contingent incentives if abstinence is verified.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Urinalysis results for alcohol use
Tidsram: From enrollment to the end of treatment at 3 months 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 with ≥150 ng/mL for EtG as a cutoff value.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for tobacco use
Tidsram: From enrollment to the end of treatment at 3 months 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 with ≥ 80ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum
Urinalysis results for cannabis use
Tidsram: From enrollment to the end of treatment at 3 months 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 with ≥50 ng/mL as a cutoff.
From enrollment to the end of treatment at 3 months postpartum

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Birth weight
Tidsram: Birth
Birth weight
Birth
Gestational age at birth
Tidsram: Birth
Gestational age at birth
Birth
Head circumference
Tidsram: Birth
Head circumference
Birth
Apgar score
Tidsram: Birth
Apgar score
Birth
NICU admission
Tidsram: Birth to 3 months postpartum
NICU admission and length of stay
Birth to 3 months postpartum
Infant weight at 3 months
Tidsram: 3 months postpartum
Infant weight at 3 months
3 months postpartum
Infant height at 3 months
Tidsram: 3 months postpartum
Infant height at 3 months
3 months postpartum

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Philadelphia College of Osteopathic Medicine

Samarbetspartners

University of Cape Town
RTI International

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 februari 2027

Primärt slutförande (Beräknad)

31 januari 2029

Avslutad studie (Beräknad)

30 juni 2029

Studieregistreringsdatum

Först inskickad

11 september 2026

Först inskickad som uppfyllde QC-kriterierna

14 september 2026

Första postat (Faktisk)

18 september 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

18 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

14 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • H26-046

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

A limited data set in which names and other personal health identifiers are removed will be supplied to researchers on request. The data will be made available after the publication of the study results. Analytic files will be collected in Redcap and then prepared in SPSS, R, SAS, or STATA, with online codebooks giving the variable name, label, type, format, positions, consistency codes, and, if applicable, values and value labels. Requesting access to data will involve drafting an abstract, checking the feasibility relative to the available data, and then seeking the permission of the principal investigator and the team for review, if appropriate. The data sets will be ready for use and can be converted to other analytic tools.

Tidsram för IPD-delning

After study outcomes are published for 3 years

Kriterier för IPD Sharing Access

those with the permission of the principal investigator and the team investigators

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF
  • ANALYTIC_CODE

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

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