NCT01859000

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2007

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
3.1 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 21, 2013

Completed
Last Updated

May 21, 2013

Status Verified

May 1, 2013

Enrollment Period

3.2 years

First QC Date

May 14, 2013

Last Update Submit

May 16, 2013

Conditions

Keywords

AdolescentsHurricane KatrinaFamily-based treatmentMultidimensional Family TherapyGroup CBT

Outcome Measures

Primary Outcomes (1)

  • Substance use

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

    Intake through the 12-month follow-up

Secondary Outcomes (3)

  • Delinquency

    One year prior to intake through the 12-month follow-up

  • Trauma Symptoms

    Screening through the 12-month follow-up

  • School Problems

    One year prior to intake through the 12-month follow-up

Study Arms (2)

Multidimensional Family Therapy

EXPERIMENTAL

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.

Other: Multidimensional Family Therapy

Group CBT

OTHER

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).

Other: Group CBT

Interventions

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.

Also known as: MDFT
Multidimensional Family Therapy

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).

Group CBT

Eligibility Criteria

Age13 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

The Center for Family and Youth Services

Luling, Louisiana, 70070, United States

Location

Related Publications (1)

  • 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.

    PMID: 20919759BACKGROUND

MeSH Terms

Conditions

Substance-Related DisordersWounds and Injuries

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental Disorders

Study Officials

  • Cynthia Rowe, Ph.D.

    University of Miami

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Associate Professor

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 21, 2013

Study Start

January 1, 2007

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

May 21, 2013

Record last verified: 2013-05

Locations