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Screening and Brief Advice to Reduce Teen Substance Use

1 de agosto de 2019 actualizado por: John R Knight, MD, Boston Children's Hospital

The purpose of this study is to test the effectiveness of a brief intervention for alcohol and drug use in adolescents that a primary care doctor can give in his/her office. The study will be conducted in nine primary care offices in three New England states, and in ten pediatric offices in Prague, Czech Republic (CZR).

We hypothesize that:

  1. Among 12-18 year old well care patients who screen positive for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing drug and alcohol use;
  2. Among 12-18 year old well care patients who screen negative for drug/alcohol use, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing initiation of drug and alcohol use as measured by self-reports of substance use;
  3. Among 12-18 year old well care patients who are at risk for riding with an impaired driver or driving while impaired, the experimental intervention administered by trained primary care providers will be more effective than standard care in decreasing Riding/Driving risk behavior as measured by a standardized scale.

Descripción general del estudio

Descripción detallada

We are trying to find out the best way for doctors to talk with their adolescent patients about alcohol and drug use. Adolescents 12-18 who are coming to their doctor's office for a routine well-care or follow-up visit will be invited to participate in the study. Participants do not have to have ever used alcohol or drugs. All participants will answer a computerized questionnaire about alcohol and drug use three times. The first one will be at the time of a doctor's visit. The second time will be three months later and the third time a year later. Adolescents who agree to be in the study during the first year will be in the 'control' group. Their doctor will talk to them about drugs and alcohol the same as he/she usually does for all his/her patients. Those who agree to be in the study during the second year will be in the 'intervention' group. Everyone in the 'intervention' group will receive some advice on the computer about their alcohol and drug use. Their doctor will also give them some specific advice about drug and alcohol use. The researchers have chosen what that advice will be, and all doctors involved in the study will give advice according to the study protocol. Participants and their parents will also be given educational information about alcohol and drugs. We will test the effectiveness of the intervention by comparing drug and alcohol use between those who are in the 'control' group, and those who are in the 'intervention' group.

We we will also validate the Czech version of the CRAFFT screen before conducting the effectiveness trial outlined above in the Czech Republic.

Tipo de estudio

Intervencionista

Inscripción (Actual)

2695

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Prague, Chequia
        • Center for the Evaluation, Prevention, and Research of Substance Abuse
    • Massachusetts
      • Boston, Massachusetts, Estados Unidos, 02111
        • Tufts-New England Medical Center
      • Cambridge, Massachusetts, Estados Unidos, 02139
        • Cambridge Pediatrics
      • Worcester, Massachusetts, Estados Unidos, 01605
        • Fallon Clinic
    • New Hampshire
      • Concord, New Hampshire, Estados Unidos, 03301
        • Capital Region Family Health Center
    • Vermont
      • Milton, Vermont, Estados Unidos, 05468
        • Milton Family Practice

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

12 años a 18 años (Niño, Adulto)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

12-18 year old patients coming for well care or follow-up visits to one of the study sites, All levels of substance use, Able to read and understand English

Exclusion Criteria:

Will not be available for 12 month follow-up period, Medically unstable at the time of the visit

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Control - New England, USA
Control participants will receive "care as usual" from their provider
Experimental: cSBA - New England, USA
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Otros nombres:
  • SBIRT
Sin intervención: Control - Prague, CZR
Control participants will receive "care as usual" from their provider
Experimental: cSBA - Prague, CZR
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking points" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Participants who are in the experimental arm will complete the CRAFFT screen on the computer and receive information on the computer regarding the health effects of substance use. Their provider will be given the results of their CRAFFT screen and a list of suggested "talking point" which they will use to guide a discussion with the patient about drug and alcohol use. Participants and their families will also receive educational brochures about substance use.
Otros nombres:
  • SBIRT

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - New England, USA
Periodo de tiempo: Past-90-days at 3 months post-baseline
Among the 12-18 year old primary care patients who reported past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Past-90-days at 3 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users, New England, USA
Periodo de tiempo: Past-90-days at 3 months post-baseline
Among the 12-18 year old primary care patients who did NOT report past-12-month drug or alcohol use at baseline in New England, USA, this analysis reports the number who subsequently reported past-90-day drug or alcohol use at the 3 months post-baseline assessment.
Past-90-days at 3 months post-baseline
Past-12-month Substance Use at 12 Months Among Baseline Substance Users, New England, USA
Periodo de tiempo: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Past-12-months at 12 months post-baseline
Past-12-month Substance Use at 12 Months, Baseline Substance Non-Users, New England, USA
Periodo de tiempo: Past-12-months at 12 months post-baseline
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 12 months post-baseline assessment in New England, USA
Past-12-months at 12 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Users - Prague, CZR
Periodo de tiempo: Past-90-days at 3 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Past-90-days at 3 months post-baseline
Past-90-day Substance Use at 3 Months Among Baseline Substance Non-Users - Prague, CZR
Periodo de tiempo: Past-90-days at 3 months post-baseline
Of those participants who reported NO past-12-month drug or alcohol use at baseline,the number reporting past-90-day drug or alcohol use at 3 months post-baseline assessment in Prague, Czech Republic
Past-90-days at 3 months post-baseline
Past-12-Month Substance Use at 12 Months Among Baseline Substance Users - Prague, CZR
Periodo de tiempo: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Past-12-months at 12 months post-baseline
Past-12-Month Substance Use at 12 Months Among Baseline Substance Non-Users - Prague, CZR
Periodo de tiempo: Past-12-months at 12 months post-baseline
Of those participants who reported past-12-month drug or alcohol use at baseline,the number reporting past-12-month drug or alcohol use at 12 months post-baseline assessment in Prague, Czech Republic
Past-12-months at 12 months post-baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Any Risky Riding or Driving at 3 Months - New England, USA
Periodo de tiempo: Past-90-days at 3 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - New England
Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - New England, USA
Periodo de tiempo: Past-90-days at 12 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - New England
Past-90-days at 12 months post-baseline
Any Risky Riding or Driving at 3 Months - Prague, CZR
Periodo de tiempo: Past-90-days at 3 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 3 months post-baseline assessment - Prague, Czech Republic
Past-90-days at 3 months post-baseline
Any Risky Riding or Driving at 12 Months - Prague, CZR
Periodo de tiempo: Past-90-days at 12 months post-baseline
Any past-90-day self-reported Riding with a driver who had used alcohol or other drugs or Driving after having used alcohol or other drugs at 12 months post-baseline assessment - Prague, Czech Republic
Past-90-days at 12 months post-baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: John R Knight, M.D., Boston Children's Hospital

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de diciembre de 2005

Finalización primaria (Actual)

1 de diciembre de 2008

Finalización del estudio (Actual)

1 de febrero de 2010

Fechas de registro del estudio

Enviado por primera vez

27 de septiembre de 2005

Primero enviado que cumplió con los criterios de control de calidad

27 de septiembre de 2005

Publicado por primera vez (Estimar)

28 de septiembre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

14 de agosto de 2019

Última actualización enviada que cumplió con los criterios de control de calidad

1 de agosto de 2019

Última verificación

1 de agosto de 2019

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • NIDA-R01DA0118848

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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