Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
Primary Purpose
Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
IPT-AST
Group Counseling
Sponsored by
About this trial
This is an interventional prevention trial for Depression focused on measuring Depression, Prevention, Adolescents
Eligibility Criteria
Inclusion Criteria:
- In 7th-10th grades at intake
- Center for Epidemiologic Studies Depression Scale(CES-D) Score > 16
- At least 2 symptoms on the K-SADS depression section (score of 2 or 3), one of which is either depressed mood, irritability, or anhedonia
- Adolescent must be English-speaking
- Parent speaks English or Spanish
Exclusion Criteria:
- CES-D Score < 15
- Fewer than 2 depression symptoms on the K-SADS (score of 2 or 3) or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia
- Suicide attempt or self-mutilation in the past year, current active suicidal ideation, and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior
- Presence of current Major Depressive Disorder, dysthymia, substance abuse, schizophrenia, bipolar disorder, conduct disorder, or psychosis
Sites / Locations
- Rutgers University
- Children's Hospital of Philadelphia
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
IPT-AST
Group Counseling
Arm Description
Interpersonal Psychotherapy-Adolescent Skills Training
Group Counseling
Outcomes
Primary Outcome Measures
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder Not Otherwise Specified (NOS) on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Secondary Outcome Measures
Children's Depression Rating Scale-Revised (CDRS-R)
Scores on the CDRS-R
Children's Depression Rating Scale-Revised
Children's Depression Rating Scale-Revised
Children's Depression Rating Scale-Revised
Children's Depression Rating Scale-Revised
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Children's Global Assessment Scale
Children's Global Assessment Scale
Children's Global Assessment Scale
Children's Global Assessment Scale
Full Information
NCT ID
NCT01201382
First Posted
September 13, 2010
Last Updated
April 5, 2021
Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), Rutgers University
1. Study Identification
Unique Protocol Identification Number
NCT01201382
Brief Title
Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
Official Title
Depression Prevention Initiative - A Study of IPT-AST in School Settings
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospital of Philadelphia
Collaborators
National Institute of Mental Health (NIMH), Rutgers University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a randomized controlled trial comparing Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) to group counseling (GC) for the prevention of depression in adolescents. The project will: (1) identify adolescents with elevated depressive symptoms but who do not meet criteria for a current mood disorder diagnosis; (2) randomize eligible adolescents to either IPT-AST (N = 100) or GC (N = 100); (3) assess depressive symptoms, depressive disorders, global functioning, interpersonal functioning, comorbid conditions and school related indices at baseline, mid-intervention, post-intervention, and at 6-, 12-, 18-, and 24-month follow-up; (4) examine the effects of IPT-AST on depression and various domains of functioning at each time point; and (5) conduct analyses to examine potential mediators and moderators of the association between IPT-AST and depression outcomes. This study will yield data on the efficacy of IPT-AST relative to GC for the prevention of depressive symptoms and depressive disorders. It will also provide information about the mechanisms of action of IPT-AST and determine for whom IPT-AST is most effective.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Prevention, Adolescents
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
185 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IPT-AST
Arm Type
Experimental
Arm Description
Interpersonal Psychotherapy-Adolescent Skills Training
Arm Title
Group Counseling
Arm Type
Active Comparator
Arm Description
Group Counseling
Intervention Type
Behavioral
Intervention Name(s)
IPT-AST
Other Intervention Name(s)
Interpersonal Psychotherapy-Adolescent Skills Training
Intervention Description
A school-based group prevention program that includes 2 individual pre-group sessions, 8 weekly 90 minute group sessions, an individual mid-group session and 4 booster sessions
Intervention Type
Behavioral
Intervention Name(s)
Group Counseling
Other Intervention Name(s)
Usual group counseling
Intervention Description
Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions
Primary Outcome Measure Information:
Title
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder Not Otherwise Specified (NOS) on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Description
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation
Time Frame
Post intervention (approximately 3 months post baseline)
Title
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time Frame
6-months post-intervention
Title
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time Frame
12-months post-intervention
Title
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time Frame
18-months post-intervention
Title
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time Frame
24-months post-intervention
Secondary Outcome Measure Information:
Title
Children's Depression Rating Scale-Revised (CDRS-R)
Description
Scores on the CDRS-R
Time Frame
Post intervention (approximately 3 months after baseline)
Title
Children's Depression Rating Scale-Revised
Time Frame
6-months post-intervention
Title
Children's Depression Rating Scale-Revised
Time Frame
12-months post-intervention
Title
Children's Depression Rating Scale-Revised
Time Frame
18-months post-intervention
Title
Children's Depression Rating Scale-Revised
Time Frame
24 months post-intervention
Title
Children's Global Assessment Scale (CGAS)
Description
Assesses global functioning
Time Frame
Post intervention (approximately 3 months following baseline)
Title
Children's Global Assessment Scale
Time Frame
6-months post-intervention
Title
Children's Global Assessment Scale
Time Frame
12-months post-intervention
Title
Children's Global Assessment Scale
Time Frame
18-months post-intervention
Title
Children's Global Assessment Scale
Time Frame
24-months post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
In 7th-10th grades at intake
Center for Epidemiologic Studies Depression Scale(CES-D) Score > 16
At least 2 symptoms on the K-SADS depression section (score of 2 or 3), one of which is either depressed mood, irritability, or anhedonia
Adolescent must be English-speaking
Parent speaks English or Spanish
Exclusion Criteria:
CES-D Score < 15
Fewer than 2 depression symptoms on the K-SADS (score of 2 or 3) or 2 or more symptoms on the K-SADS with no report of depressed mood, irritability, or anhedonia
Suicide attempt or self-mutilation in the past year, current active suicidal ideation, and/or history of a clinically significant suicidal behavior (i.e., with intent to die and high medical lethality) or repeated patterns of self-injurious behavior
Presence of current Major Depressive Disorder, dysthymia, substance abuse, schizophrenia, bipolar disorder, conduct disorder, or psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jami F Young, Ph.D.
Organizational Affiliation
Children's Hospital of Philadelphia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rutgers University
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
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