Family-Based Drug Services for Young Disaster Victims — Katrina  

Trauma Clinical Trial

Official title: Family-Based Drug Services for Young Disaster Victims

Status Completed

Clinical Trial Summary

This protocol seizes this rare scientific opportunity to test an integrative family based model to address youths' coexisting substance abuse and trauma in the wake of Hurricane Katrina. The study would address a number of gaps in the current evidence base related to understanding and treating comorbid teen drug abuse and trauma that may be initiated or exacerbated in the wake of disasters such as Hurricane Katrina. This study would compare two promising interventions for youth with comorbid trauma and substance abuse, family-based treatment and group Cognitive Behavioral Therapy (CBT), potentially yielding new and vital information about effective treatment for substance abusing youth following traumatic events.

Clinical Trial Description

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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Families
• Substance Abuse
• Trauma

• NCT number: NCT01859000
• Study type: Interventional
• Source: University of Miami
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Completion date: April 2010