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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00619411
Other study ID # 5549
Secondary ID
Status Completed
Phase Phase 1
First received February 11, 2008
Last updated March 8, 2012
Start date November 2007
Est. completion date May 2009

Study information

Verified date March 2012
Source New York State Psychiatric Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date May 2009
Est. primary completion date May 2009
Accepts healthy volunteers No
Gender Both
Age group 12 Years to 18 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Interpersonal Therapy for Depressed Adolescents & Parents
15 weekly psychotherapy sessions

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
New York State Psychiatric Institute Columbia University

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical Global Improvement (CGI), Hamilton Rating Scale for Depression (HRSD), Center for Epidemiological Studies - Depression Scale (CES-D) baseline, week 5, 10, 15 No
Secondary 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 No
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