- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07683702
Effectiveness Trial of an mHealth Intervention to Help Parents Prevent Early Onset Alcohol Use (BIPAS Alcohol)
27. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
4000
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Marina Pearsall, MPH
- Telefonnummer: 9849991617
- E-mail: mpearsall@rti.org
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
- Ældre voksen
Tager imod sunde 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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: BIPAS Alcohol intervention group
BIPAS Alcohol intervention
|
Digital intervention for parents of rising middle schoolers to prevent early onset alcohol use
Andre navne:
|
|
Ingen indgriben: Control group
Does not receive intervention
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Nisha Gottfredson O'Shea, PhD, RTI International
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. september 2026
Primær færdiggørelse (Anslået)
1. september 2029
Studieafslutning (Anslået)
1. september 2029
Datoer for studieregistrering
Først indsendt
19. juni 2026
Først indsendt, der opfyldte QC-kriterier
27. juni 2026
Først opslået (Faktiske)
6. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
27. juni 2026
Sidst verificeret
1. juni 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- R01AA031980 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Primary outcome variables for individual participants will be shared on the NIMH Data Archive
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- ICF
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med BIPAS Alcohol
-
Auburn UniversityIkke rekrutterer endnuAlkohol drikkeForenede Stater
-
University of MichiganNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetLeversygdomme | Alkohol-relaterede lidelserForenede Stater
-
Sygehus LillebaeltUkendtBakterielle infektioner | Kirurgisk procedure, uspecificeret | Operation sår; InfektionDanmark
-
Yale UniversityNational Institute on Alcohol Abuse and Alcoholism (NIAAA)Afsluttet
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol; Brug, problemForenede Stater
-
University of WashingtonNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetAlkohol drikke | Problem med at drikkeForenede Stater
-
University of California, RiversideIkke rekrutterer endnuAlkohol; Skadelig brug | AlkoholbrugsforstyrrelseForenede Stater
-
Johnson & Johnson Consumer Inc. (J&JCI)Afsluttet
-
University of North Carolina, Chapel HillNational Institute on Alcohol Abuse and Alcoholism (NIAAA); Johns Hopkins... og andre samarbejdspartnereAktiv, ikke rekrutterende
-
Abby BraitmanNational Institute on Alcohol Abuse and Alcoholism (NIAAA)AfsluttetCollege studerende drikker