- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT01859000
Family-Based Drug Services for Young Disaster Victims (Katrina)
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a 2 (treatments) by 5 (time points), repeated measures intent-to-treat randomized control design with multiple dependent variables. The sample includes a total of 150 ethnically diverse adolescents who are clinically referred for substance abuse treatment throughout St. Charles Parish, a New Orleans area parish that was heavily impacted by Hurricane Katrina. The parish has high rates of teen substance abuse as documented in school surveys (State of Louisiana Office for Addictive Disorders, 2002, 2004). Eligible youth, who meet American Society of Addiction Medicine (ASAM) criteria for outpatient substance abuse treatment and report trauma symptoms related to Hurricane Katrina, will be randomized to a family-based treatment (MDFT) or group CBT. Both treatments will be delivered approximately twice weekly over 4 months. Assessments of youth and family functioning across several domains will be conducted at intake, 2, 4, 6, and 12 month follow-up. Measuring multiple domains at several assessment points within and following treatment (Brown, 2004) will enable investigators to examine trajectories of change as well as mediators and moderators of treatment effects.
The study has four aims:
Aim 1: To explore links between hurricane-related stress and trauma and youths' substance abuse.
Hypothesis 1: Severity of youths' substance use at intake to treatment will be predicted by level of exposure to Hurricane Katrina, stressful life events following Katrina, trauma symptoms, and coping.
Aim 2: To investigate in a community based randomized control trial the effectiveness of a family-based intervention (MDFT) vs. group CBT for teen substance abusers impacted by Hurricane Katrina.
Hypothesis 2a: Family-based treatment (MDFT) will more effectively reduce youths' substance abuse, delinquency, trauma, and school problems up to one year post-intake than a group CBT approach.
Hypothesis 2b: Family-based treatment (MDFT) will more effectively reduce parents' stress and family conflict up to one year post-intake than group CBT.
Hypothesis 2c: Youth assigned to MDFT will be less likely to meet diagnostic criteria for PTSD at 12 month post-intake than group CBT.
Aim 3: To examine teen and parent coping as mediators of treatment effects.
Hypothesis 3a: Youth in MDFT will develop more effective coping strategies than those in group CBT through improved parental coping and parenting practices, and lower family conflict, as well as directly through intervention effects.
Hypothesis 3b: Youth in MDFT will achieve greater reductions in substance abuse and trauma symptoms than those in group treatment through more effective coping during the 12 month follow-up period.
Aim 4: To explore moderators of treatment effects based on post-Katrina stress and trauma symptoms.
Hypothesis 4: The advantage of MDFT over group CBT in decreasing substance abuse will be more pronounced with youth who report higher levels of disaster-related stress and trauma symptoms at intake.
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
Florida
-
Miami, Florida, Estados Unidos, 33136
- University of Miami Miller School of Medicine
-
-
Louisiana
-
Luling, Louisiana, Estados Unidos, 70070
- The Center for Family and Youth Services
-
-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Between ages of 13 and 17
- Meet ASAM criteria for outpatient substance abuse treatment
- At least mild trauma symptoms on PTSD-Reaction Index
- Not receiving any other behavioral treatment
- Parent/guardian willing to participate in the study/treatment
- Parent informed consent and youth informed assent to participate in the study
Exclusion Criteria:
- Mental retardation or pervasive developmental disorders
- Psychotic disorder as indicated by record review
- current suicidality as indicated by verbalization of ideation + intent + plan in interview
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación factorial
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
---|---|
Experimental: Multidimensional Family Therapy
MDFT is a multi-systems family-based approach (Liddle, 2002a) designed to address the multiple developmental disruptions and symptoms that result from interacting individual, family, peer, and community risk factors (Liddle, 2002a).
MDFT assesses and intervenes at multiple levels and in multiple domains of the adolescent's life -- individual, familial and extrafamilial.
|
MDFT assesses and intervenes in four domains to address comorbid substance abuse and trauma symptoms: 1) adolescent, 2) parent, 3) family, and 4) external systems.
MDFT therapists will address trauma symptoms among both teens and parents, aiming to improve coping and reduce the impact of stress on the family.
Consistent with a multidimensional approach, MDFT trauma-focused interventions address the needs of both youth and their parents, and MDFT therapists seek collaboration and advocacy from school and court personnel.
Otros nombres:
|
Otro: Group CBT
The group treatment employed in the proposed study is a state-of-the-art peer group-based CBT model.
The treatment will be based on established guidelines for CBT therapy for teen substance abuse (CSAT, 1999; Waldron & Kaminer, 2004) as well as trauma (La Greca & Silverman, in press).
The treatment adopts a risk and protective factor framework, seeking to reduce substance use both by targeting cognitions about use directly and by focusing on accompanying problem behaviors such as poor academic performance and limited social skills (Hawkins et al, 1992).
|
Trauma symptoms will be addressed using techniques designed to reduce cognitions that maintain anxiety and depressive symptoms and improve coping, such as cognitive restructuring, gradual exposure, and helping teens to understand and accept reminders of the event and ongoing stressors (Pynoos et al, 1998).
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Substance use
Periodo de tiempo: Intake through the 12-month follow-up
|
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
|
Intake through the 12-month follow-up
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Delinquency
Periodo de tiempo: One year prior to intake through the 12-month follow-up
|
Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
|
One year prior to intake through the 12-month follow-up
|
Trauma Symptoms
Periodo de tiempo: Screening through the 12-month follow-up
|
Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
|
Screening through the 12-month follow-up
|
School Problems
Periodo de tiempo: One year prior to intake through the 12-month follow-up
|
School records will be obtained for each youth enrolled in the study.
|
One year prior to intake through the 12-month follow-up
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Cynthia Rowe, Ph.D., University of Miami
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
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 (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
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
Otros números de identificación del estudio
- 20057675
- R01DA021887 (Subvención/contrato del NIH de EE. UU.)
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. .
Ensayos clínicos sobre Multidimensional Family Therapy
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)TerminadoTrastorno de ansiedadCanadá
-
Ray HershbergerNational Heart, Lung, and Blood Institute (NHLBI); National Human Genome Research...Activo, no reclutando
-
Federal University of Minas GeraisMedical Research Council; University of Southampton; Federal University of the...Inscripción por invitaciónDiabetes mellitus | Hipertensión arterialBrasil
-
NeuroTronik Inc.DesconocidoInsuficiencia cardiaca | Insuficiencia cardíaca agudaParaguay
-
Qu ShenThe First Affiliated Hospital of Xiamen UniversityAún no reclutandoCalidad de vida | Rehabilitación | Estudio piloto | Sobreviviente de cáncer colorrectal
-
Mental Health Services in the Capital Region, DenmarkTrygFonden, Denmark; Sektion for Tværsektoriel forskning - Region HovedstadenReclutamientoNiño | Crianza de los hijos | Resiliencia | Trastorno mental | Prevención | FamiliaDinamarca
-
University of Roma La SapienzaTerminadoImplante dental fallido | Mucositis BucalItalia
-
Iran University of Medical SciencesTerminadoLumbalgia MecánicaIrán (República Islámica de
-
NeuroTronik Inc.DesconocidoTerapia de estimulación autónoma del gasto cardíaco para la insuficiencia cardíaca aguda (COAST-AHF)Insuficiencia cardíaca agudaPanamá
-
Norwegian Centre for Ageing and HealthThe Research Council of Norway; Kavli Research Center for Ageing and DementiaTerminado