DepressionNCT01948167
Bending Adolescent Depression Trajectories Through Personalized Prevention
A study testing Interpersonal Psychotherapy- Adolescent Skills Training and Coping with Stress in people with Depression, run by Children's Hospital of Philadelphia at 4 sites in United States.
Trial summary
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression
- What is being tested?
- Interpersonal Psychotherapy- Adolescent Skills Training and Coping with Stress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 205 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2013to Aug 2019
- 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
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Who cannot join
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Illinois Urbana Champaign
Champaign, Illinois, 61820
University of Denver
Denver, Colorado, 80208
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Rutgers University
Piscataway, New Jersey, 08854
About this study
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
Read the detailed description
Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.
- Conditions
- Depression
- Being tested
- Interpersonal Psychotherapy- Adolescent Skills Training, Coping with Stress
- 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.
Interpersonal Psychotherapy- Adolescent Skills TrainingBehavioural
Also called IPT-AST, Teen Talk
A group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence.
Coping with StressBehavioural
Also called CWS
A group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs.
| Study group | Role | What they receive |
|---|---|---|
| Interpersonal Psychotherapy- Adolescent Skills Training | Experimental | Interpersonal Psychotherapy- Adolescent Skills Training Receives: Behavioral: Interpersonal Psychotherapy- Adolescent Skills Training |
| Coping with Stress | Experimental | Coping with Stress Receives: Behavioral: Coping with Stress |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of a Major Depressive Episode or Dysthymia 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 or Dysthymia 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: 6-months post-intervention
Presence of A Major Depressive Episode or Dysthymia 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: 12-months post-intervention
Presence of A Major Depressive Episode or Dysthymia 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: 18-months post-intervention
Presence of A Major Depressive Episode or Dysthymia 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: 24-months post-intervention
Presence of A Major Depressive Episode or Dysthymia 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: 30-months post-intervention
Presence of A Major Depressive Episode or Dysthymia 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: 36-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: Post intervention (approximately 3 months after baseline)
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 6-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 12-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 18-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 24-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 30-months post-intervention
Children's Depression Inventory (CDI)
Self-reported depression scores
Measured: 36-months post-intervention
Secondary outcomes (7)
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 6-months followup
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 12-months followup
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 18-months followup
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 24-months followup
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 30-months followup
Children's Global Assessment Scale (CGAS)
Assesses global functioning
Measured: 36-months followup
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2019
- Study completionAug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 205 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), University of Denver, Rutgers University, University of Illinois at Urbana-Champaign
- Responsible party
- Sponsor
- Investigators
- Jami F Young, Ph.D., Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01948167
- Sponsor's protocol ID
- 17-013831
- Other IDs
- R01MH077178
- Status last verified
- Mar 2021
- First submitted
- 18 Sep 2013
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jones JD, Schwartz KTG, Davis M, Gallop R, Hankin BL, Young JF. Cognitive and interpersonal moderators of two evidence-based depression prevention programs. J Consult Clin Psychol. 2024 Jul;92(7):432-444. doi: 10.1037/ccp0000886. Epub 2024 Apr 18.
PubMed 38635190Young JF, Jones JD, Gallop R, Benas JS, Schueler CM, Garber J, Hankin BL. Personalized Depression Prevention: A Randomized Controlled Trial to Optimize Effects Through Risk-Informed Personalization. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1116-1126.e1. doi: 10.1016/j.jaac.2020.11.004. Epub 2020 Nov 13.
PubMed 33189876
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bending Adolescent Depression Trajectories Through Personalized Prevention
- ClinicalTrials.gov ID
- NCT01948167
- Acronym / sponsor ID
- 17-013831
- Conditions
- Depression
- Keywords
- Depression, Prevention, Adolescents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), University of Denver, Rutgers University, University of Illinois at Urbana-Champaign
- Study start
- Sep 2013
- Primary completion
- Aug 2019 (actual)
- Study completion
- Aug 2019 (actual)
- First posted
- 23 Sep 2013 (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.
Investigators will combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence.
Detailed description
Investigators will innovatively combine risk factor research and evidence-based prevention programs, to advance knowledge on personalized approaches to prevention that may be able to better "bend trajectories" of depression that surge throughout adolescence. A randomized controlled trial will examine the benefits of matching youth to two depression prevention programs of Interpersonal Psychotherapy-Adolescent Skills Training (IPT-AST) and Coping with Stress (CWS) for the prevention of depression in adolescents. These two programs are designed to address distinct risk factors for depression - CWS addresses cognitive risks and IPT-AST addresses interpersonal risks. A total of 210 participants across two sites, University of Denver and Rutgers University, will be stratified on cognitive and interpersonal risk and randomized to the two conditions. The goals of the study are to (1) demonstrate that prevention programs can modify depression trajectories among youth by examining within person changes in trajectories over time (three years before and three years after the prevention programs) and by comparing trajectories of prevention youth with changes in same aged cohorts; (2) evaluate a personalized prevention approach to bending depression trajectories by matching and mismatching youth to either CWS or IPT-AST based on individual risk profiles; (3) examine mechanisms of bending depression trajectories and test whether the prevention programs operate via their hypothesized processes; and (4) explore how genetic susceptibility, emotion regulation, and temperament may affect individual response to IPT-AST and CWS. By implementing evidence-based prevention programs after 3-years of prospective naturalistic data collection, this study will contribute essential data on personalized medicine and altering developmental trajectories of first-onset depression.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interpersonal Psychotherapy- Adolescent Skills Training | Experimental | Behavioral: Interpersonal Psychotherapy- Adolescent Skills TrainingInterpersonal Psychotherapy- Adolescent Skills Training |
| Coping with Stress | Experimental | Behavioral: Coping with StressCoping with Stress |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Currently in the 6th to 11th grades
- Adolescent and parent must be English-speaking
- Parental consent and adolescent consent
Key exclusion criteria (3 listed)
- Presence of current Major Depressive Disorder, dysthymia, bipolar disorder, or significant psychosis
- Suicide attempt in the past week or significant suicidal ideation in the past week
- Presence of significant psychopathology or significant pervasive developmental delays that would make the group inappropriate
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 |
|---|---|---|
| Interpersonal Psychotherapy- Adolescent Skills TrainingAlso: IPT-AST, Teen TalkA group prevention program that includes a 60-minute pre-group session, 8 weekly 90-minute group sessions, a 60-minute mid-group session, and 3 60-minute booster sessions. IPT-AST focuses on psychoeducation and interpersonal skill-building to decrease interpersonal conflict and increase interpersonal support and competence. | Behavioural | Interpersonal Psychotherapy- Adolescent Skills Training |
| Coping with StressAlso: CWSA group prevention program that consists of 8 acute 90-minute group sessions, 2 parent group sessions, and 3 continuation sessions lasting 60 minutes each. Participants are taught to apply cognitive techniques to their personal thoughts, with the goal of generating effective counterarguments to unrealistic negative beliefs. | Behavioural | Coping with Stress |
Primary outcome
Presence of a Major Depressive Episode or Dysthymia 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 or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 6-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 12-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 18-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 24-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 30-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Presence of A Major Depressive Episode or Dysthymia on the Schedule for Affective Disorders for School Aged Children - Present and Life Time Version (K-SADS-PL)
Time frame: 36-months post-intervention
Presence of a depression diagnosis as measured by a semi-structured diagnostic evaluation.
Children's Depression Inventory (CDI)
Time frame: Post intervention (approximately 3 months after baseline)
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 6-months post-intervention
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 12-months post-intervention
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 18-months post-intervention
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 24-months post-intervention
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 30-months post-intervention
Self-reported depression scores
Children's Depression Inventory (CDI)
Time frame: 36-months post-intervention
Self-reported depression scores
7 secondary outcomes
Children's Global Assessment Scale (CGAS)
Time frame: Post Intervention (approximately 3 months following baseline)
Children's Global Assessment Scale (CGAS)
Time frame: 6-months followup
Children's Global Assessment Scale (CGAS)
Time frame: 12-months followup
Children's Global Assessment Scale (CGAS)
Time frame: 18-months followup
Children's Global Assessment Scale (CGAS)
Time frame: 24-months followup
Children's Global Assessment Scale (CGAS)
Time frame: 30-months followup
Children's Global Assessment Scale (CGAS)
Time frame: 36-months followup
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 4 Mar 2021.
- Derived from this study: PubMed 38635190Jones JD, Schwartz KTG, Davis M, Gallop R, Hankin BL, Young JF. Cognitive and interpersonal moderators of two evidence-based depression prevention programs. J Consult Clin Psychol. 2024 Jul;92(7):432-444. doi: 10.1037/ccp0000886. Epub 2024 Apr 18.
- Derived from this study: PubMed 33189876Young JF, Jones JD, Gallop R, Benas JS, Schueler CM, Garber J, Hankin BL. Personalized Depression Prevention: A Randomized Controlled Trial to Optimize Effects Through Risk-Informed Personalization. J Am Acad Child Adolesc Psychiatry. 2021 Sep;60(9):1116-1126.e1. doi: 10.1016/j.jaac.2020.11.004. Epub 2020 Nov 13.
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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
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interpersonal Psychotherapy- Adolescent Skills Training and Coping with Stress in people with Depression, run by Children's Hospital of Philadelphia at 4 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 3 inclusion and 3 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 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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 or Dysthymia 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 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01948167, which also lists 2 linked publications.
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 4 Mar 2021; AzTrials last refreshed its copy on 29 Oct 2026.