Una intervención de activación conductual administrada en un curso de orientación para estudiantes universitarios de primer año
Un ensayo aleatorizado por grupos de una intervención de activación conductual administrada en un curso de orientación para estudiantes universitarios de primer año
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
La transición de la escuela secundaria a la universidad es un período sensible al desarrollo que presenta un alto riesgo de aumentos en el consumo de alcohol. Aunque el consumo de riesgo de alcohol es un problema común entre los estudiantes de primer año, la participación en los servicios de tratamiento es muy baja. Pueden ocurrir bajas tasas de compromiso con los recursos de tratamiento porque las intervenciones se enfocan directamente en la bebida en un momento en que los estudiantes pueden no estar interesados en cambiar su forma de beber. Además, con un enfoque específico en el consumo de alcohol, las intervenciones actuales tampoco abordan las preocupaciones de los estudiantes de primer año, como el estrés y el sueño. Los enfoques que abordan los problemas que más preocupan a los estudiantes, que también reducen indirectamente el consumo de alcohol, pueden ser particularmente efectivos.
La activación conductual (BA) es una intervención que aborda indirectamente la psicopatía al guiar a las personas a identificar objetivos en sus vidas y alentar a las personas a participar en actividades de refuerzo que se alineen con sus objetivos (Lejuez et al, 2001). Si bien inicialmente se usó para tratar la depresión, BA se ha aplicado de manera eficaz al uso de sustancias porque BA actúa en el mismo proceso de refuerzo implicado en los problemas con la bebida. BA aborda el consumo de alcohol sin una referencia específica al consumo de alcohol centrándose en la participación en actividades de refuerzo que se alinean con las metas de los estudiantes. Un estudio piloto proporcionó una indicación inicial de que una intervención breve de BA administrada en un curso de orientación para estudiantes de primer año de un semestre de duración resultó en una disminución significativa de los problemas relacionados con la bebida, en comparación con la orientación estándar (Reynolds et al. 2011). En particular, el enfoque nunca planteó el tema de la bebida a menos que lo planteara un estudiante.
El propósito del estudio es llevar a cabo un ensayo aleatorizado por conglomerados totalmente potenciado que evalúe la BA administrada en un curso de orientación para estudiantes de primer año de un semestre de duración (16 semanas), en comparación con un curso de orientación estándar en 540 estudiantes de primer año distribuidos en 36 secciones del curso (18 secciones cada una de las BA y formato de orientación estándar). Una evaluación posterior al tratamiento de 5 meses medirá la durabilidad de los efectos. Los análisis de mediación probarán los mecanismos de acción y los análisis de moderación examinarán los factores relacionados con la eficacia. Una muestra aleatoria del 20 % de los participantes completará un seguimiento de 17 meses, que tendrá lugar al final de su segundo año de universidad, para examinar los efectos a largo plazo. Con este R01 propuesto, los investigadores probarán una intervención prometedora con BA que aborda los factores que limitan la participación en otros programas al no enfocarse directamente en el alcohol y al integrar una intervención en el plan de estudios universitario, con el beneficio adicional de probar mediadores para guiar el trabajo futuro. Esta aplicación representa un primer paso hacia el desarrollo de un curso de intervención que podría difundirse ampliamente para abordar el persistente problema de la bebida en la universidad y sus muchas consecuencias.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
Contactos y Ubicaciones
Ubicaciones de estudio
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Kansas
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Lawrence, Kansas, Estados Unidos, 66046
- University of Kansas
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de inclusión:
- Estudiantes universitarios de primer año inscritos en cursos de seminario de primer año UNIV 101 en la Universidad de Kansas asignados al estudio
Criterio de exclusión:
- Ninguno
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Curso de Activación Conductual
Condición del curso de activación conductual administrado en un seminario de orientación para estudiantes universitarios de primer año
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La activación conductual (BA) es una intervención que aborda indirectamente la psicopatía al guiar a las personas a identificar objetivos en sus vidas y alentar a las personas a participar en actividades de refuerzo que se alineen con sus objetivos (Lejuez et al, 2001).
Si bien inicialmente se usó para tratar la depresión, BA se ha aplicado de manera eficaz al uso de sustancias porque BA actúa sobre el mismo sistema de refuerzo común a muchos trastornos (Daughters et al., 2018).
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Sin intervención: Curso de Orientación Estándar
Condición estándar del curso del seminario de orientación para estudiantes de primer año
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Alcohol Consumption (AUDIT-C Score)
Periodo de tiempo: 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-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.
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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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Rate of High-intensity Drinking (2+ Times in Excess of NIAAA Low Risk Drinking Guidelines for Males and Females)
Periodo de tiempo: 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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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.
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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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Alcohol-related Problems (AUDIT-P) Score
Periodo de tiempo: 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-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
Periodo de tiempo: 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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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.
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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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Depression
Periodo de tiempo: 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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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.
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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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Binge Eating
Periodo de tiempo: 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 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
Periodo de tiempo: 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 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.
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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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Delay Discounting Rate
Periodo de tiempo: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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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
Periodo de tiempo: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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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
Periodo de tiempo: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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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)
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Grade Point Average (GPA)
Periodo de tiempo: 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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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
Periodo de tiempo: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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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
Periodo de tiempo: During treatment assessment at baseline (Visit 1), 2 months (Visit 2), 4 months (Visit 3)
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The moderator in the model was sex.
The outcome was the Alcohol Use Disorder Identification Test-Problems (AUDIT-P) 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Tera L Fazzino, PhD, University of Kansas
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Desordenes mentales
- Hiperfagia
- Signos y Síntomas Digestivos
- Síntomas de comportamiento
- Trastornos relacionados con sustancias
- Trastornos inducidos químicamente
- Trastornos relacionados con el alcohol
- Condiciones Patológicas, Signos y Síntomas
- Comportamiento
- Signos y síntomas
- Bulimia
- Alcoholismo
- Depresión
Otros números de identificación del estudio
- STUDY00143954
- 1R01AA027791-01 (Subvención/contrato del NIH de EE. UU.)
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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