Clinical trial NCT00883519: The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Official title: The Efficacy of Parent Involvement in the Treatment of Adolescent Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Major Depressive Disorder
Dysthymic Disorder
Depressive Disorder NOS
Adjustment Disorder
Lead sponsor: New York State Psychiatric Institute
Sponsor class: OTHER
Collaborators: name: Columbia University
First posted: 2009-04-17
Enrollment: 15
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Children's Depression Rating Scale
timeFrame: baseline, week 4, 8, 12, 16, 32
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
Study officials:
References: