Family-Based Drug Services for Young Disaster Victims

NCT ID: NCT01859000

Last Updated: 2013-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Substance Abuse Families Trauma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Multidimensional Family Therapy

Intervention Type OTHER

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.

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).

Group Type OTHER

Group CBT

Intervention Type OTHER

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).

Interventions

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Multidimensional Family Therapy

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

Group CBT

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).

Intervention Type OTHER

Other Intervention Names

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MDFT

Eligibility Criteria

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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
Minimum Eligible Age

13 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Cynthia Rowe

Research Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cynthia Rowe, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami Miller School of Medicine

Miami, Florida, United States

Site Status

The Center for Family and Youth Services

Luling, Louisiana, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 20919759 (View on PubMed)

Other Identifiers

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R01DA021887

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20057675

Identifier Type: -

Identifier Source: org_study_id

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