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Interpersonal Psychotherapy for Depressed Adolescents and Parents

Primary Purpose

Major Depression, Dysthymic Disorder, Adjustment Disorders

Status
Completed
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Interpersonal Therapy for Depressed Adolescents & Parents
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depression focused on measuring Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified, Adolescent, Psychotherapy

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    I

    Arm Description

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    February 11, 2008
    Last Updated
    March 8, 2012
    Sponsor
    New York State Psychiatric Institute
    Collaborators
    Columbia University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00619411
    Brief Title
    Interpersonal Psychotherapy for Depressed Adolescents and Parents
    Official Title
    An Open Clinical Trial of Interpersonal Psychotherapy for Depressed Adolescence and Parents
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2007 (undefined)
    Primary Completion Date
    May 2009 (Actual)
    Study Completion Date
    May 2009 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    New York State Psychiatric Institute
    Collaborators
    Columbia University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.
    Detailed Description
    Adolescent depression is a significant public health problem, and it increases the risk of poor psychosocial outcomes in adolescence and adulthood. Interpersonal Psychotherapy for Depressed Adolescents (IPT-A) has been found to be an effective treatment for reducing adolescents' depressive symptoms and improving their global and social functioning. The purpose of the current study is to examine the feasibility and acceptability of IPT-A when it is delivered with greater and more structured involvement of the parents in the treatment. Participants will receive 15 weeks of Interpersonal Psychotherapy for Depressed Adolescents and Parents (IPT-AP). Eight the therapy sessions are conducted with the adolescent individually, two are with the parent(s) individually, and five are conducted with the adolescent and parent(s) together. At the end of the 15 weeks, participants who have demonstrated at least a 50% reduction in depressive symptoms will participate in three booster sessions delivered on a monthly basis. All participants will be assessed at baseline, week 5, week 10, week 15 (post-treatment), and 3 months post-treatment to measure depressive symptoms, global and social functioning, and attitudes toward treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Major Depression, Dysthymic Disorder, Adjustment Disorders, Depressive Disorder Not Otherwise Specified
    Keywords
    Major Depression, Dysthymic Disorder, Adjustment Disorder, With Depressed Mood, Depressive, Disorder Not, Otherwise, Specified, Adolescent, Psychotherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    I
    Arm Type
    Experimental
    Intervention Type
    Behavioral
    Intervention Name(s)
    Interpersonal Therapy for Depressed Adolescents & Parents
    Intervention Description
    15 weekly psychotherapy sessions
    Primary Outcome Measure Information:
    Title
    Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D)
    Time Frame
    baseline, week 5, 10, 15
    Secondary Outcome Measure Information:
    Title
    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
    Time Frame
    baseline, week 5, 10, 15

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    12 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Meredith Gunlicks-Stoessel, Ph.D.
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Interpersonal Psychotherapy for Depressed Adolescents and Parents

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