Family-Based Drug Services for Young Disaster Victims (Katrina)
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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Florida
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Miami、Florida、アメリカ、33136
- University of Miami Miller School of Medicine
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Louisiana
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Luling、Louisiana、アメリカ、70070
- The Center for Family and Youth Services
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：階乗代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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.
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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.
他の名前：
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他の：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).
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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).
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Substance use
時間枠：Intake through the 12-month follow-up
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The Timeline Follow-Back Method, Personal Experiences Inventory and Urinalyses will be used to measure substance use.
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Intake through the 12-month follow-up
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Delinquency
時間枠：One year prior to intake through the 12-month follow-up
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Court records and the National Youth Survey Self-Report Delinquency Scale (SRD)will be used to assess delinquency.
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One year prior to intake through the 12-month follow-up
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Trauma Symptoms
時間枠：Screening through the 12-month follow-up
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Posttraumatic Stress Disorder Reaction Index Revised will be used to measure trauma symptoms with youth.
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Screening through the 12-month follow-up
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School Problems
時間枠：One year prior to intake through the 12-month follow-up
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School records will be obtained for each youth enrolled in the study.
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One year prior to intake through the 12-month follow-up
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Cynthia Rowe, Ph.D.、University of Miami
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。