NCT00883519

Brief Summary

The primary aim of this study is to examine whether adolescent depression and the family context in which it develops is best treated using an individual adolescent intervention or an intervention that includes both the adolescent and the parents. This will be accomplished by conducting a randomized controlled pilot study of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) in comparison to Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for phase_1 major-depressive-disorder

Timeline
Completed

Started Jan 2009

Typical duration for phase_1 major-depressive-disorder

Geographic Reach
1 country

1 active site

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

January 1, 2009

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 17, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

April 16, 2009

Last Update Submit

April 12, 2012

Conditions

Outcome Measures

Primary Outcomes (1)

  • Children's Depression Rating Scale

    baseline, week 4, 8, 12, 16, 32

Study Arms (2)

IPT-A

ACTIVE COMPARATOR
Behavioral: Interpersonal Psychotherapy for Depressed Adolescents

IPT-AP

ACTIVE COMPARATOR
Behavioral: Interpersonal Psychotherapy for Depressed AdolescentsBehavioral: Interpersonal Psychotherapy for Depressed Adolescents and Parents

Interventions

12 psychotherapy sessions delivered over 16 weeks

IPT-AIPT-AP

12 psychotherapy sessions delivered over 16 weeks

IPT-AP

Eligibility Criteria

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

You may qualify if:

  • Ages 12-17
  • English speaking adolescent and parent
  • One parent/primary caregiver willing to participate in adolescent's treatment
  • Meets diagnostic criteria for Major Depressive Disorder, Dysthymic Disorder, Depressive Disorder NOS, or Adjustment Disorder with Depressed Mood
  • BDI-II \> 14
  • CDRS-R \> 36
  • CGAS \> 65
  • CBQ T score \>65

You may not qualify if:

  • Severe episode of Major Depressive Disorder (CDRS-R \> 85 and/or PI clinical assessment)
  • Current significant risk for suicide (active suicidal ideation with plan; active suicidal ideation without a plan if unable to contract for safety
  • Meets diagnostic criteria for substance abuse, schizophrenia, psychosis, bipolar disorder, conduct disorder, or eating disorder
  • mental retardation
  • medical illness likely to complicate or interfere with treatment
  • currently in active treatment for depression
  • currently taking medication for a psychiatric diagnosis other than ADHD or not on a stable dose of medication for ADHD (\<3 months)
  • Parent psychiatrically hospitalized within the past 3 months or parent psychopathology significantly severe to interfere with participation in their adolescent's treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderDepressionAdjustment Disorders

Interventions

Interpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersBehavioral SymptomsBehaviorTrauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 16, 2009

First Posted

April 17, 2009

Study Start

January 1, 2009

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

April 13, 2012

Record last verified: 2012-04

Locations