- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01859000
Family-Based Drug Services for Young Disaster Victims (Katrina)
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Florida
-
Miami, Florida, Forenede Stater, 33136
- University of Miami Miller School of Medicine
-
-
Louisiana
-
Luling, Louisiana, Forenede Stater, 70070
- The Center for Family and Youth Services
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Faktoriel opgave
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: 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.
|
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.
Andre navne:
|
Andet: 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).
|
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).
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Substance use
Tidsramme: Intake through the 12-month follow-up
|
The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
|
Intake through the 12-month follow-up
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Delinquency
Tidsramme: One year prior to intake through the 12-month follow-up
|
Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
|
One year prior to intake through the 12-month follow-up
|
Trauma Symptoms
Tidsramme: Screening through the 12-month follow-up
|
Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
|
Screening through the 12-month follow-up
|
School Problems
Tidsramme: One year prior to intake through the 12-month follow-up
|
School records will be obtained for each youth enrolled in the study.
|
One year prior to intake through the 12-month follow-up
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Cynthia Rowe, Ph.D., University of Miami
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 20057675
- R01DA021887 (U.S. NIH-bevilling/kontrakt)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
Kliniske forsøg med Trauma
-
John SontichRekruttering
-
Children's Hospital of PhiladelphiaRekrutteringForhåbning | Trauma; KomplikationerForenede Stater
-
University Hospital, GrenobleAfsluttet
-
Arrowhead Regional Medical CenterAfsluttetTraumeskade | Trauma Blunt | Vaskulært traumeForenede Stater
-
Humacyte, Inc.Aktiv, ikke rekrutterendeTrauma | Traumeskade | Traume, multiple | Trauma BluntUkraine
-
Methodist Health SystemRekrutteringPenetrerende Trauma Registry og Open Source DataForenede Stater
-
Centre de recherche du Centre hospitalier universitaire...Canadian Institutes of Health Research (CIHR); Université de SherbrookeAfsluttetSund og rask | Spinal traume | Højhastighedsbrud | Kranielt traumaCanada
-
Chang, Steve S., M.D.Santa Barbara Cottage Hospital; Accumetrics, Inc.AfsluttetHovedskade Trauma BluntForenede Stater
-
University of FloridaMassachusetts General Hospital; National Institutes of Health (NIH); National...AfsluttetMultipel organsvigt | Trauma; KomplikationerForenede Stater
-
Karakter Kinder- en JeugdpsychiatrieIkke rekrutterer endnu
Kliniske forsøg med Multidimensional Family Therapy
-
Nemours Children's ClinicWashington University School of MedicineAfsluttet
-
Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongAfsluttetOrdblindhed | Specialundervisning | Børn med særlige behovHong Kong
-
Nemours Children's ClinicAfsluttetDiabetes mellitus, type 2 | Fedme hos børnForenede Stater
-
Hong Kong Baptist UniversityUniversity Grants Committee, Hong KongAfsluttetAttention-deficit/Hyperactivity Disorder | Specialundervisning | Attention Deficit Disorder | Børn med særlige behov | HyperaktivitetsforstyrrelseHong Kong
-
Nemours Children's ClinicAfsluttetDiabetes mellitus, type 2 | Fedme hos børnForenede Stater
-
University of BathAfsluttetHjerte-kar-sygdomme | Type 2 diabetes mellitus | Motorisk aktivitetDet Forenede Kongerige
-
Columbia UniversityNational Institute on Minority Health and Health Disparities (NIMHD)Rekruttering
-
University of MichiganAfsluttetKvinder med BRCA 1 eller BRCA 2 mutation | Ikke-testede kvindelige familiemedlemmerForenede Stater
-
Johns Hopkins UniversityNational Institute on Disability, Independent Living, and Rehabilitation... og andre samarbejdspartnereAfsluttetDepression | Livskvalitet | Plejerbyrde | Mild kognitiv svækkelse | Handicap Fysisk | Demens, mild | Svækkelse, kognitivForenede Stater
-
University of TalcaNational Fund for Research and Development in Health, ChileIkke rekrutterer endnu