Substance AbuseKatrinaNCT01859000
Family-Based Drug Services for Young Disaster Victims
A study testing Multidimensional Family Therapy and Group CBT in people with Substance Abuse and Families, run by University of Miami at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Substance Abuse, Families, Trauma
- What is being tested?
- Multidimensional Family Therapy and Group CBT
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Center for Family and Youth Services
Luling, Louisiana, 70070
University of Miami Miller School of Medicine
Miami, Florida, 33136
About this study
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.
Read the 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.
- Conditions
- Substance Abuse, Families, Trauma
- Being tested
- Multidimensional Family Therapy, Group CBT
- Keywords
- Adolescents, Hurricane Katrina, Family-based treatment, Multidimensional Family Therapy, Group CBT
- Medical subject headings
- Substance-Related Disorders, Wounds and Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multidimensional Family TherapyOther
Also called MDFT
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 CBTOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Group CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance use
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
Measured: Intake through the 12-month follow-up
Secondary outcomes (3)
Delinquency
Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
Measured: One year prior to intake through the 12-month follow-up
Trauma Symptoms
Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
Measured: Screening through the 12-month follow-up
School Problems
School records will be obtained for each youth enrolled in the study.
Measured: One year prior to intake through the 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2013 (estimated)
- Study startJan 2007
- Primary completionApr 2010
- Study completionApr 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Cynthia Rowe, University of Miami
- Investigators
- Cynthia Rowe, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01859000
- Sponsor's protocol ID
- 20057675
- Other IDs
- R01DA021887
- Acronym
- Katrina
- Status last verified
- May 2013
- First submitted
- 14 May 2013
- Last updated
- 21 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20919759
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Family-Based Drug Services for Young Disaster Victims
- ClinicalTrials.gov ID
- NCT01859000
- Acronym / sponsor ID
- Katrina / 20057675
- Conditions
- Substance Abuse, Families, Trauma
- Keywords
- Adolescents, Hurricane Katrina, Family-based treatment, Multidimensional Family Therapy, Group CBT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2007
- Primary completion
- Apr 2010 (actual)
- Study completion
- Apr 2010 (actual)
- First posted
- 21 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multidimensional Family Therapy | Experimental | Other: Multidimensional Family TherapyMDFT 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 CBT | Other | Other: Group CBTThe 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). |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multidimensional Family TherapyAlso: MDFTMDFT 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. | Other | Multidimensional Family Therapy |
| Group CBTTrauma 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). | Other | Group CBT |
Primary outcome
Substance use
Time frame: Intake through the 12-month follow-up
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
3 secondary outcomes
Delinquency
Time frame: One year prior to intake through the 12-month follow-up
Trauma Symptoms
Time frame: Screening through the 12-month follow-up
School Problems
Time frame: One year prior to intake through the 12-month follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2013.
- Background: PubMed 20919759Rowe 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cynthia Rowe, Ph.D. principal investigator
University of Miami
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multidimensional Family Therapy and Group CBT in people with Substance Abuse and Families, run by University of Miami at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Substance use (time frame: Intake through the 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01859000, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2013.