NCT00619411

Brief Summary

The purpose of this study is to examine the feasibility and acceptability of an adaptation of Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) that includes greater and more structured involvement of the parents in the treatment.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2007

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

November 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 11, 2008

Completed
10 days until next milestone

First Posted

Study publicly available on registry

February 21, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

March 9, 2012

Status Verified

March 1, 2012

Enrollment Period

1.5 years

First QC Date

February 11, 2008

Last Update Submit

March 8, 2012

Conditions

Keywords

Major DepressionDysthymic DisorderAdjustment DisorderWith Depressed MoodDepressiveDisorder NotOtherwiseSpecifiedAdolescentPsychotherapy

Outcome Measures

Primary Outcomes (1)

  • Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)

    baseline, week 5, 10, 15

Secondary Outcomes (1)

  • Global Assessment Scale for Children (C-GAS), Social Adjustment Scale - Self-report (SAS-SR), Conflict Behavior Questionnaire (CBQ-20), Observational assessment of parent-adolescent communication

    baseline, week 5, 10, 15

Study Arms (1)

I

EXPERIMENTAL
Behavioral: Interpersonal Therapy for Depressed Adolescents & Parents

Interventions

15 weekly psychotherapy sessions

I

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Meets diagnostic criteria for major depression, dysthymic disorder, depressive disorder not otherwise specified, or adjustment disorder with depressed mood
  • Score between 10 and 28 on the HRSD
  • Score of 65 or less on the C-GAS
  • English-speaking adolescent
  • Parental or legal guardian consent to participate

You may not qualify if:

  • Actively suicidal
  • Score greater than 28 on the HRSD
  • Mentally retarded
  • Meets diagnostic criteria for current substance abuse, schizophrenia, bipolar disorder, psychosis, conduct disorder, or eating disorder
  • Currently in active treatment for depression
  • Taking antidepressant medication at the time of baseline assessment
  • Medical illness likely to complicate or interfere with treatment
  • Victim of ongoing or previously undisclosed child abuse
  • Parent psychiatrically hospitalized within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depressive Disorder, MajorDysthymic DisorderAdjustment Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersTrauma and Stressor Related Disorders

Study Officials

  • Meredith Gunlicks-Stoessel, Ph.D.

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

February 11, 2008

First Posted

February 21, 2008

Study Start

November 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

March 9, 2012

Record last verified: 2012-03