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Family-Based Drug Services for Young Disaster Victims (Katrina)

Primary Purpose

Substance Abuse, Families, Trauma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multidimensional Family Therapy
Group CBT
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Substance Abuse focused on measuring Adolescents, Hurricane Katrina, Family-based treatment, Multidimensional Family Therapy, Group CBT

Eligibility Criteria

13 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Miami Miller School of Medicine
  • The Center for Family and Youth Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Multidimensional Family Therapy

Group CBT

Arm Description

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.

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).

Outcomes

Primary Outcome Measures

Substance use
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.

Secondary Outcome Measures

Delinquency
Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
Trauma Symptoms
Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
School Problems
School records will be obtained for each youth enrolled in the study.

Full Information

First Posted
May 14, 2013
Last Updated
May 16, 2013
Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01859000
Brief Title
Family-Based Drug Services for Young Disaster Victims
Acronym
Katrina
Official Title
Family-Based Drug Services for Young Disaster Victims
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
April 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Substance Abuse, Families, Trauma
Keywords
Adolescents, Hurricane Katrina, Family-based treatment, Multidimensional Family Therapy, Group CBT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multidimensional Family Therapy
Arm Type
Experimental
Arm Description
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.
Arm Title
Group CBT
Arm Type
Other
Arm Description
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).
Intervention Type
Other
Intervention Name(s)
Multidimensional Family Therapy
Other Intervention Name(s)
MDFT
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Group CBT
Intervention Description
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).
Primary Outcome Measure Information:
Title
Substance use
Description
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
Time Frame
Intake through the 12-month follow-up
Secondary Outcome Measure Information:
Title
Delinquency
Description
Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
Time Frame
One year prior to intake through the 12-month follow-up
Title
Trauma Symptoms
Description
Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
Time Frame
Screening through the 12-month follow-up
Title
School Problems
Description
School records will be obtained for each youth enrolled in the study.
Time Frame
One year prior to intake through the 12-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia Rowe, Ph.D.
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
The Center for Family and Youth Services
City
Luling
State/Province
Louisiana
ZIP/Postal Code
70070
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20919759
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.
Results Reference
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Family-Based Drug Services for Young Disaster Victims

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