- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07683702
Effectiveness Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use (BIPAS Alcohol)
27. juni 2026 oppdatert av: Nisha Gottfredson O'Shea, RTI International
Type I Hybrid Implementation Effectiveness Cluster Randomized Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use
Many parents are permissive about children's alcohol use (e.g., they allow sips of alcohol); this leniency increases the risk that children will experience serious alcohol-related consequences as they become teenagers.
This promising digital intervention that teaches parents about their influence and provides skills and tools they need to discourage underage alcohol use.
Studieoversikt
Status
Har ikke rekruttert ennå
Intervensjon / Behandling
Detaljert beskrivelse
Drinking before age 14, or "early-onset alcohol use" (EOAU), is a serious and highly prevalent risk behavior that often begins at home, with sips of alcohol provided by parents.
By age 11, nearly one-quarter of U.S. children have already sipped alcohol.
This research has identified specific parenting beliefs and behaviors that are not being adequately addressed in family-based interventions.
This research shows that many parents who provide alcohol have the mistaken belief that doing so teaches children how to drink in moderation; other parents report simply not having given thought to the risks.
Even in the context of other protective factors, adolescents whose parents had permissive beliefs about alcohol use exhibited quicker escalations in alcohol involvement across adolescence than did those whose parents had less permissive beliefs.
The investigators developed and piloted an intervention program called Better Informed Parents Keeping Adolescents Safe from Alcohol (BIPAS Alcohol), which is a universal, theory-informed, digital intervention for parents of incoming middle schoolers that is delivered via mobile devices.
Findings from the pilot study demonstrated that BIPAS is highly acceptable to parents and can be delivered at low cost.
Furthermore, preliminary results show that BIPAS Alcohol is effective across a range of cognitive and behavioral outcomes, including parental provision of sips of alcohol to their children.
Building on this research, the current application has the following aims.
Aim 1: Expand the reach of BIPAS Alcohol by translating it into Spanish while maintaining fidelity to key intervention content; Aim 2: Use a rigorous national cluster-randomized trial with 2,000 parent-child dyads (N = 4,000 total) to assess the effects of BIPAS Alcohol on EOAU, secondary outcomes (e.g., children's alcohol use susceptibility), and hypothesized mediators that are the target of the intervention (e.g., parental permissive beliefs about adolescent alcohol use) relative to an attention control condition; and Aim 3: Evaluate implementation outcomes, including program reach, participant engagement and experience, and delivery cost.
Aim 3 will include qualitative interviews to identify implementation supports that address factors that inhibit engagement.
Across all aims, the investigators will examine variability in mechanisms and outcomes across multiple dimensions, including parent language, educational attainment, and alcohol use status.
By rigorously testing the effectiveness of a universal digital intervention with the potential for widespread reach, this study will provide novel evidence for reducing EOAU and its associated consequences.
Furthermore, findings regarding implementation supports for reaching families will provide insights into how best to support engagement more broadly across other digital parenting interventions.
Studietype
Intervensjonell
Registrering (Antatt)
4000
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Marina Pearsall, MPH
- Telefonnummer: 9849991617
- E-post: mpearsall@rti.org
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
Inclusion Criteria:
- Be age 18 or older and
- Be the parent or guardian of a child in or entering 5th or 6th grade
- Cohabitate part-time (averaging at least 2 days/week) or more with index child
- Consent to being randomized to study arm
- Be able to complete study activities in Spanish or English
- Own or have regular access to a smartphone that can download apps
- Be willing to turn on app notifications for the study app
- Consent to having their child complete surveys privately
Exclusion Criteria:
- Another child from the same family/household is already participating
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: BIPAS Alcohol intervention group
BIPAS Alcohol intervention
|
Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use
Andre navn:
|
|
Ingen inngripen: Control group
Does not receive intervention
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adolescent alcohol quantity frequency (AQF)
Tidsramme: From enrollment to 24 months
|
Frequency and amount of drinking over the past 30 days
|
From enrollment to 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent alcohol attitudes and beliefs
Tidsramme: From enrollment to 24 months
|
Questionnaire responses to items focusing on parent's beliefs about anticipated effects of alcohol consumption.
Response options are: strongly agree; disagree; agree; and strongly agree.
|
From enrollment to 24 months
|
|
Parental allowance of sipping
Tidsramme: From enrollment to 24 months
|
Questionnaire responses to item asking if parent allows child to sip alcohol.
Response options are: never; rarely; sometimes; often; very often.
|
From enrollment to 24 months
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Nisha Gottfredson O'Shea, PhD, RTI International
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
1. september 2026
Primær fullføring (Antatt)
1. september 2029
Studiet fullført (Antatt)
1. september 2029
Datoer for studieregistrering
Først innsendt
19. juni 2026
Først innsendt som oppfylte QC-kriteriene
27. juni 2026
Først lagt ut (Faktiske)
6. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juli 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
27. juni 2026
Sist bekreftet
1. juni 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- R01AA031980 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-planbeskrivelse
Primary outcome variables for individual participants will be shared on the NIMH Data Archive
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- ICF
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .