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Bending Adolescent Depression Trajectories Through Personalized Prevention

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ClinicalTrials.gov Identifier: NCT01948167
Recruitment Status : Active, not recruiting
First Posted : September 23, 2013
Last Update Posted : September 26, 2018
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
University of Denver
Rutgers University
University of Illinois at Urbana-Champaign
Information provided by (Responsible Party):
Children's Hospital of Philadelphia

Brief 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.

Condition or disease Intervention/treatment Phase
Depression Behavioral: Interpersonal Psychotherapy- Adolescent Skills Training Behavioral: Coping with Stress Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bending Adolescent Depression Trajectories Through Personalized Prevention
Study Start Date : September 2013
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Interpersonal Psychotherapy- Adolescent Skills Training
Interpersonal Psychotherapy- Adolescent Skills Training
Behavioral: Interpersonal Psychotherapy- Adolescent Skills Training
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.
Other Names:
  • IPT-AST
  • Teen Talk

Experimental: Coping with Stress
Coping with Stress
Behavioral: Coping with Stress
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.
Other Name: CWS




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.


Secondary Outcome Measures :
  1. Children's Depression Inventory (CDI) [ Time Frame: Post intervention (approximately 3 months after baseline) ]
    Self-reported depression scores

  2. Children's Depression Inventory (CDI) [ Time Frame: 6-months post-intervention ]
    Self-reported depression scores

  3. Children's Depression Inventory (CDI) [ Time Frame: 12-months post-intervention ]
    Self-reported depression scores

  4. Children's Depression Inventory (CDI) [ Time Frame: 18-months post-intervention ]
    Self-reported depression scores

  5. Children's Depression Inventory (CDI) [ Time Frame: 24-months post-intervention ]
    Self-reported depression scores

  6. Children's Depression Inventory (CDI) [ Time Frame: 30-months post-intervention ]
    Self-reported depression scores

  7. Children's Depression Inventory (CDI) [ Time Frame: 36-months post-intervention ]
    Self-reported depression scores

  8. Children's Global Assessment Scale (CGAS) [ Time Frame: Post Intervention (approximately 3 months following baseline) ]
    Assesses global functioning

  9. Children's Global Assessment Scale (CGAS) [ Time Frame: 6-months followup ]
    Assesses global functioning

  10. Children's Global Assessment Scale (CGAS) [ Time Frame: 12-months followup ]
    Assesses global functioning

  11. Children's Global Assessment Scale (CGAS) [ Time Frame: 18-months followup ]
    Assesses global functioning

  12. Children's Global Assessment Scale (CGAS) [ Time Frame: 24-months followup ]
    Assesses global functioning

  13. Children's Global Assessment Scale (CGAS) [ Time Frame: 30-months followup ]
    Assesses global functioning

  14. Children's Global Assessment Scale (CGAS) [ Time Frame: 36-months followup ]
    Assesses global functioning



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Currently in the 6th to 11th grades
  • Adolescent and parent must be English-speaking
  • Parental consent and adolescent consent

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01948167


Locations
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United States, Colorado
University of Denver
Denver, Colorado, United States, 80208
United States, Illinois
University of Illinois Urbana Champaign
Champaign, Illinois, United States, 61820
United States, New Jersey
Rutgers University
Piscataway, New Jersey, United States, 08854
United States, Pennsylvania
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19146
Sponsors and Collaborators
Children's Hospital of Philadelphia
National Institute of Mental Health (NIMH)
University of Denver
Rutgers University
University of Illinois at Urbana-Champaign
Investigators
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Principal Investigator: Jami F Young, Ph.D. Children's Hospital of Philadelphia

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Responsible Party: Children's Hospital of Philadelphia
ClinicalTrials.gov Identifier: NCT01948167     History of Changes
Other Study ID Numbers: 17-013831
R01MH077178 ( U.S. NIH Grant/Contract )
First Posted: September 23, 2013    Key Record Dates
Last Update Posted: September 26, 2018
Last Verified: September 2018

Keywords provided by Children's Hospital of Philadelphia:
Depression
Prevention
Adolescents

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders