Pennsylvania Adolescent Intervention Research Study (PAIRStudy)
| Tracking Information | |||||||||||||
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| First Received Date ICMJE | May 22, 2006 | ||||||||||||
| Last Updated Date | August 16, 2007 | ||||||||||||
| Start Date ICMJE | December 2006 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Reduction in depression as measured by the Hamilton Depression Rating Scale-17. | ||||||||||||
| Original Primary Outcome Measures ICMJE |
Reduction in number of cigarettes per week as measured by the Timeline Followback.; cessation as verified by saliva cotinine assay. | ||||||||||||
| Change History | Complete list of historical versions of study NCT00329199 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
Smoking initiation or cessation at week 52, as measured by the Timeline Follow-Back. | ||||||||||||
| Original Secondary Outcome Measures ICMJE |
Reduction in depression as measured by reduction in scores on the Hamilton Depression Rating Scale-17. | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | Pennsylvania Adolescent Intervention Research Study (PAIRStudy) | ||||||||||||
| Official Title ICMJE | TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) | ||||||||||||
| Brief Summary | Through the TRIAD Project: Pennsylvania Adolescent Intervention Research Study (PAIRStudy; Project 3a) we aim to test the efficacy of a brief treatment aimed at treating depression and family conflict among a population of adolescents with depression, and thereby reducing the future chance of these adolescents initiating smoking. We will examine Attachment-Based Family Therapy (ABFT) for the treatment of depression in comparison with Enhanced Usual Care for Depression (EUCd). Reduction of depression will be measured by a clinically significant reduction of score on the Hamilton Rating Scale for Depression. Second, we will examine how reduction of family conflict mediates the effect of ABFT on depression. The third aim will be an exploratory look at the potential prevention of the onset of smoking. Specifically, we will examine if reduction of depression and/or reductions in family conflict regardless of treatment type reduces the initiation of smoking or reduces smoking behavior at 52 weeks. These aims will be accomplished by randomizing 240 adolescents to one of two treatment conditions: a) Attachment-Based Family Therapy or b) Enhanced Usual Care for Depression. Patients randomized to the ABFT condition will receive 6-12 weeks of family therapy. Patients enrolled in the EUCd condition will be referred for outpatient psychological services at an agency that fits their geographic and financial needs. Research staff will help patients navigate the referral process. All participating therapists will have carried out the full, manualized treatment with 2-3 pilot cases prior to treating any randomized cases. |
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| Detailed Description | The TRIAD project aims to address the persistent and acute problem of depression in a population largely made up of low-income disadvantaged youth. There are numerous treatment studies available for depression, but few exist studying the treatment of depression via the reduction of family conflict. Through this clinical trial, we aim to investigate the efficacy of a treatment for depression for adolescents largely recruited through primary care. The primary aim of this study is to test whether Attachment-Based Family Therapy reduces depression more effectively than enhanced usual care for depression. Attachment-Based Family Therapy (ABFT) is a manualized therapy designed exclusively for anxious and depressed adolescents. Secondly, we intend to examine how reduction in family conflict mediates the effect of ABFT on depression. We will, furthermore, examine whether reduction in depression or reduction in family conflict, regardless of treatment type reduces the likelihood of smoking initiation at one year. These aims will be accomplished through a randomized clinical trial of 240 adolescents who meet criteria for a DSM-IV depressive disorder (Major Depressive Disorder, Dysthymia, or Depression NOS). Participants will be randomized into one of two treatment conditions. The two treatment conditions are as follows: Attachment-based Family Therapy for depression or Enhanced Usual Care for Depression. Treatment for Attachment-Based Family Therapy includes anywhere from 6-12 sessions. Some of the 6-12 sessions will include the patient and or the parent meeting alone with the therapists, others will include the family meeting together for family therapy sessions. The Enhanced Usual Care condition will include referrals to outside counseling or therapy, and the number of sessions will vary by patient and practitioner desire. In addition to their treatment sessions, patients and their parents will be required to complete intake, 6-week, 12-week, 26-week, and 52-week assessments. These assessments will include a large battery of self-report measures covering numerous topics around family conflict, risk-taking behavior (including smoking) and depression. The intake, 12, 26 and 52 week assessments will include a diagnostic interview. Additionally, bi-weekly for 12 weeks, adolescent's will be asked to complete a brief set of questionnaires that will help monitor their progress and safety. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 2 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Single Blind Primary Purpose: Treatment |
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| Condition ICMJE | Depression | ||||||||||||
| Intervention ICMJE | Behavioral: Attachment-Based Family Therapy | ||||||||||||
| Study Arm (s) | Not Provided | ||||||||||||
| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Terminated | ||||||||||||
| Estimated Enrollment ICMJE | 240 | ||||||||||||
| Completion Date | May 2007 | ||||||||||||
| Primary Completion Date | Not Provided | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||||||
| Ages | 12 Years to 18 Years | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT00329199 | ||||||||||||
| Other Study ID Numbers ICMJE | SAP#4100027295 | ||||||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||||||
| Responsible Party | Not Provided | ||||||||||||
| Study Sponsor ICMJE | Pennsylvania Department of Health | ||||||||||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | Pennsylvania Department of Health | ||||||||||||
| Verification Date | August 2007 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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