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Completed

NCT Number: NCT01948167

Bending Adolescent Depression Trajectories Through Personalized Prevention

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.

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Denver, Denver, Colorado, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Interpersonal Psychotherapy- Adolescent Skills Training

Behavioral

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

Coping with Stress

Behavioral

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 names: CWS

Primary outcomes

  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.

  8. Children's Depression Inventory (CDI)

    Time frame: Post intervention (approximately 3 months after baseline)

    Self-reported depression scores

  9. Children's Depression Inventory (CDI)

    Time frame: 6-months post-intervention

    Self-reported depression scores

  10. Children's Depression Inventory (CDI)

    Time frame: 12-months post-intervention

    Self-reported depression scores

  11. Children's Depression Inventory (CDI)

    Time frame: 18-months post-intervention

    Self-reported depression scores

  12. Children's Depression Inventory (CDI)

    Time frame: 24-months post-intervention

    Self-reported depression scores

  13. Children's Depression Inventory (CDI)

    Time frame: 30-months post-intervention

    Self-reported depression scores

  14. Children's Depression Inventory (CDI)

    Time frame: 36-months post-intervention

    Self-reported depression scores

Secondary outcomes

  1. Children's Global Assessment Scale (CGAS)

    Time frame: Post Intervention (approximately 3 months following baseline)

    Assesses global functioning

  2. Children's Global Assessment Scale (CGAS)

    Time frame: 6-months followup

    Assesses global functioning

  3. Children's Global Assessment Scale (CGAS)

    Time frame: 12-months followup

    Assesses global functioning

  4. Children's Global Assessment Scale (CGAS)

    Time frame: 18-months followup

    Assesses global functioning

  5. Children's Global Assessment Scale (CGAS)

    Time frame: 24-months followup

    Assesses global functioning

  6. Children's Global Assessment Scale (CGAS)

    Time frame: 30-months followup

    Assesses global functioning

  7. Children's Global Assessment Scale (CGAS)

    Time frame: 36-months followup

    Assesses global functioning

Sponsors and collaborators

Lead sponsor

Children's Hospital of Philadelphia

Other

Collaborators

  • National Institute of Mental Health (NIMH)
  • Rutgers University
  • University of Denver
  • University of Illinois at Urbana-Champaign

Registry information

Important dates

Study start
2013
Primary completion
2019
Study completion
2019
First posted
Sep 23, 2013
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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