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Completed

NCT Number: NCT00883519

The Efficacy of Parent Involvement in the Treatment of Adolescent Depression

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).

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Key information

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

New York State Psychiatric Institute

New York, 10032, United States

About this study

The primary aim of this project is to examine whether adolescent depression and the family context within 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). Twenty-two families with adolescents (ages 12-17) who meet criteria for major depressive disorder, dysthymic disorder, depressive disorder NOS, or adjustment disorder with depressed mood and also report elevated levels of parent-adolescent relationship problems will be randomized to receive IPT-A or IPT-AP. Assessments will be administered at screening, baseline, week 4, week 8, week 12, week 16 (post-treatment), and 4 months post-treatment. Outcome measures will include depression symptoms, quality of parent-adolescent relationships, parents' and adolescents' communication skills (assessed through observational coding of a parent-adolescent conflict negotiation task), and adolescents' physiological stress responses to negotiating conflict with a parent (assessed through collection of salivary cortisol). Identifying the best approach to treating both the adolescent's depression and the family environment in which it develops and is maintained would have significant implications for the long-term outcomes of depressed adolescents and their families.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Interpersonal Psychotherapy for Depressed Adolescents

Behavioral

12 psychotherapy sessions delivered over 16 weeks

Interpersonal Psychotherapy for Depressed Adolescents and Parents

Behavioral

12 psychotherapy sessions delivered over 16 weeks

Primary outcomes

  1. Children's Depression Rating Scale

    Time frame: baseline, week 4, 8, 12, 16, 32

Sponsors and collaborators

Lead sponsor

New York State Psychiatric Institute

Other

Collaborators

  • Columbia University

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Apr 17, 2009
Registry last updated
Apr 13, 2012

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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