Clinical trial NCT01859000: Family-Based Drug Services for Young Disaster Victims
Official title: Family-Based Drug Services for Young Disaster Victims
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance Abuse
Families
Trauma
Keywords: Adolescents
Hurricane Katrina
Family-based treatment
Multidimensional Family Therapy
Group CBT
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2013-05-21
Enrollment: 80
Sex: ALL
Minimum age (years): 13
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Substance use
timeFrame: Intake through the 12-month follow-up
Secondary outcomes:
measure: Delinquency
timeFrame: One year prior to intake through the 12-month follow-up
measure: Trauma Symptoms
timeFrame: Screening through the 12-month follow-up
measure: School Problems
timeFrame: One year prior to intake through the 12-month follow-up
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Miller School of Medicine
state: Florida
city: Luling
country: United States
facility: The Center for Family and Youth Services
state: Louisiana
Study officials:
affiliation: University of Miami
name: Cynthia Rowe, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rowe CL, La Greca AM, Alexandersson A. Family and individual factors associated with substance involvement and PTS symptoms among adolescents in greater New Orleans after Hurricane Katrina. J Consult Clin Psychol. 2010 Dec;78(6):806-817. doi: 10.1037/a0020808.