- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04038190
En beteendeaktiveringsintervention som administreras i en orienteringskurs för förstaårsstudenter
En klusterrandomiserad prövning av en beteendeaktiveringsintervention administrerad i en orienteringskurs för förstaårsstudenter
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Övergången från gymnasiet till högskolan är en utvecklingskänslig period med stor risk för eskalering av alkoholbruk. Även om riskfyllt drickande är ett vanligt problem bland förstaårsstudenter, är engagemanget i behandlingstjänster mycket lågt. Låga engagemang med behandlingsresurser kan uppstå eftersom interventioner riktar sig direkt till drickandet vid en tidpunkt då elever kan vara ointresserade av att ändra sitt drickande. Dessutom, med ett riktat fokus på alkoholanvändning, tar nuvarande insatser inte heller upp problemen hos inkommande förstaårsstudenter, såsom stress och sömn. Tillvägagångssätt som tar itu med de problem som eleverna är mest oroade över, som också indirekt minskar drickandet, kan vara särskilt effektiva.
Beteendeaktivering (BA) är en intervention som indirekt tar itu med psykopati genom att vägleda individer att identifiera mål i deras liv och uppmuntra individer att engagera sig i förstärkande aktiviteter som är i linje med deras mål (Lejuez et al, 2001). Även om BA ursprungligen användes för att behandla depression, har BA använts effektivt på droganvändning eftersom BA verkar på samma förstärkningsprocess som är inblandad i problemdrickande. BA tar upp drickande utan specifik hänvisning till alkoholanvändning genom att fokusera på engagemang i att förstärka aktiviteter som är i linje med elevernas mål. En pilotstudie gav en första indikation på att en kort BA-intervention administrerad i en terminslång orienteringskurs för förstaårsstudenter resulterade i en signifikant minskning av alkoholrelaterade problem, jämfört med standardorientering (Reynolds et al. 2011). Anmärkningsvärt är att tillvägagångssättet aldrig tog upp frågan om drickande om det inte togs upp av en student själv.
Syftet med studien är att genomföra en fullständigt driven kluster randomiserad testning BA som administreras i en terminslång (16 veckor) nybörjarorienteringskurs, jämfört med en standardorienteringskurs i 540 förstaårsstudenter fördelade på 36 kursavsnitt (18 avsnitt vardera av BA och standardorienteringsformat). En bedömning efter 5 månader efter behandling kommer att mäta effekternas varaktighet. Mediationsanalyser kommer att testa verkningsmekanismer och moderationsanalyser kommer att undersöka faktorer relaterade till effektivitet. Ett slumpmässigt urval av 20% av deltagarna kommer att genomföra en 17 månader lång uppföljning, som kommer att ske i slutet av deras andra år på college, för att undersöka långsiktiga effekter. Med denna föreslagna R01 kommer utredarna att testa en lovande intervention med BA som tar itu med faktorer som begränsar deltagandet i andra program genom att inte rikta in sig på alkohol direkt och genom att integrera en intervention i högskolans läroplan, med den extra fördelen av att testa medlare för att vägleda framtida arbete. Denna ansökan representerar ett första steg mot att utveckla en interventionskurs som skulle kunna spridas brett för att ta itu med det ihållande dricksproblemet och dess många konsekvenser.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
-
-
Kansas
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Lawrence, Kansas, Förenta staterna, 66046
- University of Kansas
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-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Beskrivning
Inklusionskriterier:
- Nybörjarstudenter inskrivna i UNIV 101 förstaårsseminariekurser vid University of Kansas tilldelade studien
Exklusions kriterier:
- Ingen
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Beteendeaktiveringskurs
Beteendeaktiverande kurstillstånd administrerat i ett orienteringsseminarium för förstaårsstudenter
|
Beteendeaktivering (BA) är en intervention som indirekt tar itu med psykopati genom att vägleda individer att identifiera mål i deras liv och uppmuntra individer att engagera sig i förstärkande aktiviteter som är i linje med deras mål (Lejuez et al, 2001).
Även om BA ursprungligen användes för att behandla depression, har BA använts effektivt på droganvändning eftersom BA verkar på samma förstärkningssystem som är gemensamt för många sjukdomar (Daughters et al., 2018).
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Inget ingripande: Standard orienteringskurs
Standard kursvillkor för förstaårsorienteringsseminarium
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Alcohol Consumption (AUDIT-C Score)
Tidsram: 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)
Tidsram: 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)
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Alcohol-related Problems (AUDIT-P) Score
Tidsram: 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.
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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)
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Exceeding Clinical Cutoff of 8+ for Hazardous/Harmful Drinking on the AUDIT
Tidsram: 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)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Depression
Tidsram: 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)
|
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Binge Eating
Tidsram: 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.
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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)
|
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Stress
Tidsram: 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)
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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Delay Discounting Rate
Tidsram: 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.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Total Reinforcement Ratio (TRR) Between Alcohol-related and Alcohol-free Sources of Reinforcement
Tidsram: 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.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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Moderation of Treatment Effects (AUDIT Total) Based on Coping-motivated Drinking
Tidsram: 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)
Tidsram: 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.
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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)
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Moderation of Treatment Effects (AUDIT-C) by Sex
Tidsram: 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.
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During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
|
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Moderation of Treatment Effects (AUDIT-P) by Sex
Tidsram: 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)
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Tera L Fazzino, PhD, University of Kansas
Publikationer och användbara länkar
Allmänna publikationer
- Fazzino TL, Lejuez CW, Yi R. A behavioral activation intervention administered in a 16-week freshman orientation course: Study protocol. Contemp Clin Trials. 2020 Mar;90:105950. doi: 10.1016/j.cct.2020.105950. Epub 2020 Jan 23.
- Jun D, Fazzino TL. Associations between Alcohol-Free Sources of Reinforcement and the Frequency of Alcohol and Cannabis Co-Use among College Freshmen. Int J Environ Res Public Health. 2023 Feb 7;20(4):2884. doi: 10.3390/ijerph20042884.
- Exum AC, Sutton CA, Bellitti JS, Yi R, Fazzino TL. Delay discounting and substance use treatment outcomes: A systematic review focused on treatment outcomes and discounting methodology. J Subst Use Addict Treat. 2023 Jun;149:209037. doi: 10.1016/j.josat.2023.209037. Epub 2023 Apr 16.
- Fazzino TL, Kunkel A, Bellitti J, Romine RS, Yi R, McDaniel C, Lejuez CW. Engagement with Activity Monitoring During a Behavioral Activation Intervention: A Randomized Test of Monitoring Format and Qualitative Evaluation of Participant Experiences. Behav Change. 2023 Jun;40(2):103-116. doi: 10.1017/bec.2022.7. Epub 2022 Jun 16.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY00143954
- 1R01AA027791-01 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
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