FASD Prevention R33 (R33)
14. September 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
184
Phase
- Phase 2
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Yukiko Washio, PhD
- Telefonnummer: (215) 871-6100
- E-Mail: yukikowa@pcom.edu
Studienorte
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Cape Town, Südafrika
- University of Cape Town
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Kontakt:
- Heather Jaspan, MD, PhD
- Telefonnummer: +27 21 650 9111
- E-Mail: hbjaspan@gmail.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Nein
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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Aktiver 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.
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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.
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Experimental: 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.
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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.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Urinalysis results for alcohol use
Zeitfenster: From enrollment to the end of treatment at 3 months postpartum
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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.
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From enrollment to the end of treatment at 3 months postpartum
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Urinalysis results for tobacco use
Zeitfenster: From enrollment to the end of treatment at 3 months postpartum
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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.
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From enrollment to the end of treatment at 3 months postpartum
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Urinalysis results for cannabis use
Zeitfenster: From enrollment to the end of treatment at 3 months postpartum
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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.
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From enrollment to the end of treatment at 3 months postpartum
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Birth weight
Zeitfenster: Birth
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Birth weight
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Birth
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Gestational age at birth
Zeitfenster: Birth
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Gestational age at birth
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Birth
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Head circumference
Zeitfenster: Birth
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Head circumference
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Birth
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Apgar score
Zeitfenster: Birth
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Apgar score
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Birth
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NICU admission
Zeitfenster: Birth to 3 months postpartum
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NICU admission and length of stay
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Birth to 3 months postpartum
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Infant weight at 3 months
Zeitfenster: 3 months postpartum
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Infant weight at 3 months
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3 months postpartum
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Infant height at 3 months
Zeitfenster: 3 months postpartum
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Infant height at 3 months
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3 months postpartum
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
1. Februar 2027
Primärer Abschluss (Geschätzt)
31. Januar 2029
Studienabschluss (Geschätzt)
30. Juni 2029
Studienanmeldedaten
Zuerst eingereicht
11. September 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. September 2026
Zuerst gepostet (Tatsächlich)
18. September 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
18. September 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. September 2026
Zuletzt verifiziert
1. September 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- H26-046
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
JA
Beschreibung des IPD-Plans
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.
IPD-Sharing-Zeitrahmen
After study outcomes are published for 3 years
IPD-Sharing-Zugriffskriterien
those with the permission of the principal investigator and the team investigators
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ICF
- ANALYTIC_CODE
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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