NCT01948167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
Completed

Started Sep 2013

Longer than P75 for not_applicable depression

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

September 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2019

Completed
Last Updated

March 4, 2021

Status Verified

March 1, 2021

Enrollment Period

5.9 years

First QC Date

September 18, 2013

Last Update Submit

March 2, 2021

Conditions

Depression

Keywords

DepressionPreventionAdolescents

Outcome Measures

Primary Outcomes (14)

  • 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.

    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.

    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.

    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.

    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.

    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.

    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.

    36-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    Post intervention (approximately 3 months after baseline)

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    6-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    12-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    18-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    24-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    30-months post-intervention

  • Children's Depression Inventory (CDI)

    Self-reported depression scores

    36-months post-intervention

Secondary Outcomes (7)

  • Children's Global Assessment Scale (CGAS)

    Post Intervention (approximately 3 months following baseline)

  • Children's Global Assessment Scale (CGAS)

    6-months followup

  • Children's Global Assessment Scale (CGAS)

    12-months followup

  • Children's Global Assessment Scale (CGAS)

    18-months followup

  • Children's Global Assessment Scale (CGAS)

    24-months followup

  • +2 more secondary outcomes

Study Arms (2)

Interpersonal Psychotherapy- Adolescent Skills Training

EXPERIMENTAL

Interpersonal Psychotherapy- Adolescent Skills Training

Behavioral: Interpersonal Psychotherapy- Adolescent Skills Training

Coping with Stress

EXPERIMENTAL

Coping with Stress

Behavioral: Coping with Stress

Interventions

Interpersonal Psychotherapy- Adolescent Skills TrainingBEHAVIORAL

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.

Also known as: IPT-AST, Teen Talk
Interpersonal Psychotherapy- Adolescent Skills Training
Coping with StressBEHAVIORAL

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.

Also known as: CWS
Coping with Stress

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

University of Denver

Denver, Colorado, 80208, United States

Location

University of Illinois Urbana Champaign

Champaign, Illinois, 61820, United States

Location

Rutgers University

Piscataway, New Jersey, 08854, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19146, United States

Location

Related Publications (2)

  • 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.

    PMID: 38635190DERIVED

  • Young 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.

    PMID: 33189876DERIVED

MeSH Terms

Conditions

Depression

Interventions

Coping Skills

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Jami F Young, Ph.D.

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 23, 2013

Study Start

September 1, 2013

Primary Completion

August 1, 2019

Study Completion

August 1, 2019

Last Updated

March 4, 2021

Record last verified: 2021-03

Locations

US(4)