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En adfærdsaktiveringsintervention administreret i et College Freshman-orienteringskursus

26. maj 2026 opdateret af: University of Kansas

Et klynge-randomiseret forsøg med en adfærdsaktiveringsintervention administreret i et college Freshman-orienteringskursus

Overgangen fra gymnasiet til gymnasiet er en udviklingsmæssigt følsom periode, der er høj risiko for eskalering af alkoholforbrug. Selvom risikofyldt drikkeri er et almindeligt problem blandt nybegyndere, er engagementet i behandlingstilbud meget lavt. Den foreslåede undersøgelse vil teste en adfærdsaktiverende intervention, der adresserer faktorer, der begrænser deltagelse i standardbehandlingsydelser ved at målrette alkoholforbrug indirekte, ved direkte at adressere de bekymringer, der er mest relevante for kommende førsteårsstuderende, og ved at integrere en intervention i kollegiets læseplan.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Detaljeret beskrivelse

Overgangen fra gymnasiet til gymnasiet er en udviklingsmæssigt følsom periode, der er høj risiko for eskalering af alkoholforbrug. Selvom risikofyldt drikkeri er et almindeligt problem blandt nybegyndere, er engagementet i behandlingstilbud meget lavt. Lav grad af engagement med behandlingsressourcer kan forekomme, fordi interventioner retter sig direkte mod drikkeri på et tidspunkt, hvor eleverne kan være uinteresserede i at ændre deres drikkeri. Desuden, med et målrettet fokus på alkoholbrug, adresserer de nuværende interventioner heller ikke bekymringerne hos kommende nybegyndere, såsom stress og søvn. Tilgange, der adresserer de problemer, eleverne er mest bekymrede over, og som også indirekte reducerer drikkeri, kan være særligt effektive.

Behavioural Activation (BA) er en intervention, der indirekte adresserer psykopati ved at vejlede individer til at identificere mål i deres liv og opmuntre individer til at engagere sig i forstærkende aktiviteter, der stemmer overens med deres mål (Lejuez et al, 2001). Mens BA oprindeligt blev brugt til at behandle depression, er BA blevet effektivt anvendt til stofbrug, fordi BA virker på den samme forstærkende proces, der er involveret i problemdrikning. BA behandler drikkeri uden specifik henvisning til alkoholbrug ved at fokusere på engagement i at styrke aktiviteter, der stemmer overens med elevernes mål. Et pilotstudie gav en indledende indikation af, at en kort BA-intervention administreret i et semesterlangt førsteårsorienteringskursus resulterede i et signifikant fald i drikkerelaterede problemer sammenlignet med standardorientering (Reynolds et al. 2011). Det er bemærkelsesværdigt, at tilgangen aldrig rejste spørgsmålet om at drikke, medmindre den blev rejst af en studerende selv.

Formålet med undersøgelsen er at udføre en fuldt powered klynge randomiseret forsøgstest BA administreret i et semesterlangt (16 ugers) førsteårsorienteringskursus sammenlignet med et standardorienteringskursus i 540 førsteårsstuderende fordelt på 36 kursusafsnit (18 sektioner hver af de BA og standard orienteringsformat). En 5-måneders efterbehandlingsvurdering vil måle virkningernes holdbarhed. Mediationsanalyser vil teste virkningsmekanismer, og moderationsanalyser vil undersøge faktorer relateret til effektivitet. En tilfældig stikprøve på 20 % af deltagerne vil gennemføre en 17 måneders opfølgning, som vil finde sted i slutningen af ​​deres andet år på college, for at undersøge langsigtede effekter. Med denne foreslåede R01 vil efterforskerne teste en lovende intervention med BA, der adresserer faktorer, der begrænser deltagelse i andre programmer ved ikke at målrette alkohol direkte og ved at integrere en intervention i colleges pensum, med den ekstra fordel af at teste mediatorer til at guide det fremtidige arbejde. Denne applikation repræsenterer et første skridt i retning af at udvikle et interventionskursus, der kunne udbredes bredt for at løse det vedvarende college-drikproblem og dets mange konsekvenser.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

572

Fase

  • Fase 2

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Kansas
      • Lawrence, Kansas, Forenede Stater, 66046
        • University of Kansas

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

17 år og ældre (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Beskrivelse

Inklusionskriterier:

  • College freshmen tilmeldt UNIV 101 freshman seminar kurser ved University of Kansas tildelt undersøgelsen

Ekskluderingskriterier:

  • Ingen

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: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Adfærdsaktiveringskursus
Adfærdsaktiveringskursustilstand administreret i et orienteringsseminar for førsteårsstuderende på college
Behavioural Activation (BA) er en intervention, der indirekte adresserer psykopati ved at vejlede individer til at identificere mål i deres liv og opmuntre individer til at engagere sig i forstærkende aktiviteter, der stemmer overens med deres mål (Lejuez et al, 2001). Mens BA oprindeligt blev brugt til at behandle depression, er BA blevet anvendt effektivt til stofbrug, fordi BA virker på det samme forstærkningssystem, der er fælles for mange lidelser (Daughters et al., 2018).
Ingen indgriben: Standard orienteringskursus
Standard førsteårs orientering seminar kursus tilstand

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Alcohol Consumption (AUDIT-C Score)
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-Use Disorders Identification Test- Consumption Questions (AUDIT-C), which are the first three items of the AUDIT 10-item measure that asses frequency of drinking, typical quantity, and frequency of heavy drinking occasions (Saunders et al, 1993; Bush et al, 1998; DeMartini et al 2012). Responses are on a likert scale ranging from 0-4. The 3 items are summed for a total score with a possible range of 0-12, with higher scores indicating riskier drinking behavior.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
The Time Line Follow Back-Computerized (TLFB-C) assessment was used to measure alcohol consumption in the past 30 days (Sobell & Sobell, 2008), or since the prior measurement period. The measure was used to obtain the number of days during which individuals engaged in high-intensity drinking of 8+ drinks for males or 10+ drinks for females per drinking occasion. The number of days participants engaged in high intensity drinking was summed per measurement period, and converted to a rate to reflect the number of high intensity drinking days out of the number of days in the measurement period (high intensity drinking days/days in measurement period). The rate was used because there could be slightly different numbers of days across measurement periods, depending on when participants completed the assessment.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-related Problems (AUDIT-P) Score
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Alcohol-Use Disorders Identification Test- Problem questions (AUDIT-P) are the last 7 items of the full AUDIT that assess increased salience of drinking, morning drinking, guilt after drinking, blackouts, alcohol-related injuries, and drinking that others are concerned about (Saunders et al, 1993; O'Hare & Sherrer, 2005). Responses are on a likert scale ranging from 0-4. The 7 items were summed for a total score on the AUDIT-P, with a possible range of 0-28, with higher scores indicating greater alcohol-related problems.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
The Alcohol-Use Disorders Identification Test (AUDIT) is designed to assess hazardous alcohol use and alcohol-related problems. The AUDIT has 10 items (Saunders et al, 1993) and responses are on a likert scale ranging from 0-4. The 10 items are summed for a total score with a possible range of 0-40, with higher scores indicating greater likelihood of hazardous drinking behavior. A total score of 8 or higher was used as a binary variable to identify participants with hazardous drinking (score 8+). Outcome was the proportion of respondents exceeding the clinical cut point.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Depression
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Depression was measured using the Depression Anxiety Stress Scale (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The measure provides scales for depression, anxiety, and stress and conceptualizes the difference between normal and clinical populations as a matter of degree. The depression scale assesses dysphoria, hopelessness, devaluation of life, self-deprecation, lack of interest / involvement, anhedonia and inertia with 7 items. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater depression.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Binge Eating
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Binge eating was measured with the Eating Pathology Symptoms Inventory (EPSI; Forbush et al., 2013). The binge eating subscale was used in the study, which includes items on overeating and loss of control eating. The binge eating subscale has 8 items with Likert scale responses from 0=never to 4= very often. Items are summed for a scale score ranging from 0-32. Higher scores indicate more frequent experiences with binge eating behavior.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Stress
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)
Stress was measured using the Depression Anxiety Stress Scale-21 (DASS-21), a 21 item measure designed to assess depression, anxiety and stress (Lovibond & Lovibond, 1995). The stress scale score was used to assess stress. Items are on a 4-point Likert scale ranging from 0-3 and can be summed for a scale score ranging from 0-21. Higher scores indicate greater stress.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3); post-treatment follow up assessment at and 5 months (all participants) and 17 months (for participants in cohorts 1-3)

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Delay Discounting Rate
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Delay discounting was calculated from a computer adjusting delay discounting task that asked participants to choose between smaller immediate rewards and larger, delayed rewards. The reward used in the task was hypothetical money. Mazur's hyperbolic function, V = A/ 1 + kD, was used to estimate each participant's delay discounting rate (i.e., k) for use in analyses. For this formula, V is the discounted value of a delayed reward (i.e., indifference point), A is the reward amount, D is the delay in days, and k represents the estimated delay discounting rate. Greater k values indicated stronger discounting and a preference for immediate monetary rewards. K values across the sample ranged from -11.06 to 2.43. Negative values generally indicate stronger discounting, whereas positive values typically represent less steep discounting.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The Adolescent Reinforcement Survey Schedule - Alcohol Use Version assesses the frequency of past-month engagement in and enjoyment derived from 45 activities (Hallgren et al, 2016). Each question is posed twice - once to assess the frequency and enjoyment of the activity while using alcohol and the once to assess the frequency and enjoyment of the activity while not using alcohol. Items range from 0-4. Frequency and enjoyment items are summed to form respective scores. From these scales, two subscales are created for alcohol-related reinforcement and alcohol-free reinforcement, calculated as the cross product between frequency and enjoyment items for alcohol-related and alcohol-free questions. The two subscales were used to calculate the outcome, the total reinforcement ratio (TRR) between alcohol-related and alcohol-free reinforcement. The ratio has values between 0 and 1, with higher values indicating more relative enjoyment of activities when using alcohol.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Moderator: The Drinking Motives Questionnaire-Revised (DMQ-R) is designed to measure the relative frequency of drinking for four distinct reason motives: enhancement, social, conformity, and coping (Cooper, 1994; Cox & Klinger, 1988). The study used the coping motives scale, which contains 5 items. Items are assessed on a Likert scale ranging from 1-5 and are summed for form a scale score, which higher scores indicating greater endorsement of drinking to cope with stress/distress.

Outcome: The outcome used in the analysis was the Alcohol Use Disorder Identification Test (AUDIT) total score; we originally planned to use AUDIT-Consumption and AUDIT-Problems subscales for two separate analyses and outcomes (in parallel with other moderation analyses); however the models did not converge. Therefore, AUDIT total score was used as the outcome in analyses.

During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Grade Point Average (GPA)
Tidsramme: GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
Academic performance was measured using participant self-reported grade point average (GPA). College freshmen first received their GPA in the spring semester of college, which was at the 5 month follow up. Thus, we examined whether there were significant differences in GPA across treatment and control conditions at 5 month adn 17 month follow ups.
GPA was available and assessed during post-treatment follow up at and 5 months (all participants) and 17 months (for participants in Years 1-3)
Moderation of Treatment Effects (AUDIT-C) by Sex
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The moderator used in analyses was sex. The outcome was the Alcohol Use Disorder Identification Test- Consumption (AUDIT-C) subscale score.
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
Moderation of Treatment Effects (AUDIT-P) by Sex
Tidsramme: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
The moderator in the model was sex. The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) subscale score
During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: Tera L Fazzino, PhD, University of Kansas

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

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 (Faktiske)

5. september 2019

Primær færdiggørelse (Faktiske)

30. maj 2025

Studieafslutning (Faktiske)

30. maj 2025

Datoer for studieregistrering

Først indsendt

27. juni 2019

Først indsendt, der opfyldte QC-kriterier

26. juli 2019

Først opslået (Faktiske)

30. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

28. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. maj 2026

Sidst verificeret

1. december 2025

Mere information

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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 .

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