DepressionNCT01201382
Depression Prevention Initiative - A Study of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) in School Settings
A study testing IPT-AST and Group Counseling in people with Depression, run by Children's Hospital of Philadelphia at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- IPT-AST and Group Counseling
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 185 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2010to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Rutgers University
Piscataway, New Jersey, 08854
About this study
Official title: Depression Prevention Initiative - A Study of IPT-AST in School Settings
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.
- Conditions
- Depression
- Being tested
- IPT-AST, Group Counseling
- Keywords
- Depression, Prevention, Adolescents
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPT-ASTBehavioural
Also called Interpersonal Psychotherapy-Adolescent Skills Training
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
Group CounselingBehavioural
Also called Usual group counseling
Usual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions
| Study group | Role | What they receive |
|---|---|---|
| IPT-AST | Experimental | Interpersonal Psychotherapy-Adolescent Skills Training Receives: Behavioral: IPT-AST |
| Group Counseling | Active comparator | Group Counseling Receives: Behavioral: Group Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Post intervention (approximately 3 months post baseline)
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Measured: 6-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Measured: 12-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Measured: 18-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Measured: 24-months post-intervention
Secondary outcomes (10)
Children's Depression Rating Scale-Revised (CDRS-R)
Scores on the CDRS-R
Measured: Post intervention (approximately 3 months after baseline)
Children's Depression Rating Scale-Revised
Measured: 6-months post-intervention
Children's Depression Rating Scale-Revised
Measured: 12-months post-intervention
Children's Depression Rating Scale-Revised
Measured: 18-months post-intervention
Children's Depression Rating Scale-Revised
Measured: 24 months post-intervention
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: Post intervention (approximately 3 months following baseline)
Children's Global Assessment Scale
Measured: 6-months post-intervention
Children's Global Assessment Scale
Measured: 12-months post-intervention
Children's Global Assessment Scale
Measured: 18-months post-intervention
Children's Global Assessment Scale
Measured: 24-months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startOct 2010
- Primary completionJun 2015
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 185 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers University
- Responsible party
- Sponsor
- Investigators
- Jami F Young, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201382
- Sponsor's protocol ID
- MH087481
- Other IDs
- R01MH087481
- Status last verified
- Apr 2021
- First submitted
- 13 Sep 2010
- Last updated
- 8 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression Prevention Initiative - A Study of IPT-AST in School Settings
- ClinicalTrials.gov ID
- NCT01201382
- Acronym / sponsor ID
- MH087481
- Conditions
- Depression
- Keywords
- Depression, Prevention, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 185 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Rutgers University
- Study start
- Oct 2010
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 14 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPT-AST | Experimental | Behavioral: IPT-ASTInterpersonal Psychotherapy-Adolescent Skills Training |
| Group Counseling | Active comparator | Behavioral: Group CounselingGroup Counseling |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IPT-ASTAlso: Interpersonal Psychotherapy-Adolescent Skills TrainingA 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 | Behavioural | IPT-AST |
| Group CounselingAlso: Usual group counselingUsual group counseling as delivered by school counselors; 1 pre-group session, 1 mid-group session, 8 90-minute group sessions, 4 booster sessions | Behavioural | Group Counseling |
Primary outcome
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)
Time frame: Post intervention (approximately 3 months post baseline)
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
Time frame: 6-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time frame: 12-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time frame: 18-months post-intervention
Presence of a Major Depressive Episode, Dysthymia or Depressive Disorder NOS on the K-SADS-PL
Time frame: 24-months post-intervention
10 secondary outcomes
Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Post intervention (approximately 3 months after baseline)
Children's Depression Rating Scale-Revised
Time frame: 6-months post-intervention
Children's Depression Rating Scale-Revised
Time frame: 12-months post-intervention
Children's Depression Rating Scale-Revised
Time frame: 18-months post-intervention
Children's Depression Rating Scale-Revised
Time frame: 24 months post-intervention
Children's Global Assessment Scale (CGAS)
Time frame: Post intervention (approximately 3 months following baseline)
Children's Global Assessment Scale
Time frame: 6-months post-intervention
Children's Global Assessment Scale
Time frame: 12-months post-intervention
Children's Global Assessment Scale
Time frame: 18-months post-intervention
Children's Global Assessment Scale
Time frame: 24-months post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jami F Young, Ph.D. principal investigator
Children's Hospital of Philadelphia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPT-AST and Group Counseling in people with Depression, run by Children's Hospital of Philadelphia at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: Post intervention (approximately 3 months post baseline)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2021.