Ignite Creation Date:
2024-05-05 @ 4:51 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00329199
Status:
TERMINATED
Last Update Posted:
2007-08-20
First Post:
2006-05-22
Brief Title:
Pennsylvania Adolescent Intervention Research Study PAIRStudy
Sponsor:
Pennsylvania Department of Health
Organization:
Pennsylvania Department of Health
Study Overview
Official Title:
TRIAD Project Pennsylvania Adolescent Intervention Research Study PAIRStudy Project 3a
Status:
TERMINATED
Status Verified Date:
2007-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Trial was rewritten and will no longer focus on the link between smoking and depression
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 andor 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
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 adolescents will be asked to complete a brief set of questionnaires that will help monitor their progress and safety
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 adolescents will be asked to complete a brief set of questionnaires that will help monitor their progress and safety
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None