Concurrent Treatment for Depressed Parents and DepressedAdolescents

NCT00951821 | Completed Results DMC

• 3 other identifiers: R34MH082211DSIR 84 CTSNCT00951821
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will develop an integrated treatment for adolescents who are depressed and suicidal and their parents who are depressed and have a history of suicidality.

Conditions

Depression; Suicide

Keywords

Suicidal Ideation; Suicide Attempts

Outcome Measures

Primary Outcomes (1)

• Beck Depression Inventory - Adolescent Report, Change in Symptom Level

  self-report measure of depressed mood - range of scores 0 to 60; higher scores indicate worse depression. The data in this outcome refer to change from baseline to 12 month follow-up, per the adolescent self-report.

  12 months

Secondary Outcomes (1)

• Beck Suicide Scale - Adolescent Response

  Measured at 12 months

Study Arms (2)

Concurrent treatment

EXPERIMENTAL

Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.

Behavioral: Concurrent treatment

Adolescent treatment only

ACTIVE COMPARATOR

Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.

Behavioral: Adolescent treatment only

Interventions

Concurrent treatment BEHAVIORAL

Individual CBT sessions for parents and adolescents plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase. The techniques used to teach cognitive restructuring and problem solving to parents will be similar to those taught to the adolescents, except emotion regulation skills will be added to the parent treatment.

Also known as: CBT for adolescents and parents

Concurrent treatment

Adolescent treatment only BEHAVIORAL

Individual CBT for adolescents only plus combined parent-adolescent family sessions, delivered weekly for 3 months in the acute phase and bimonthly for 3 months in the maintenance phase

Adolescent treatment only

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Lives at home with at least one parent or guardian
• Speaks English
• Must have made a suicide attempt and be diagnosed with major depressive disorder (MDD)
• Speaks English
• Current diagnosis of MDD and a history of suicidality

You may not qualify if:

• Judged to have developmental or cognitive delays or psychotic disorders on the basis of a standard psychiatric exam
• Diagnosis of bipolar disorder or a substance dependence (people with a diagnosis of substance abuse are eligible)
• Only one adolescent per family is eligible
• Diagnosis of bipolar disorder or substance dependence
• If taking antidepressants, not on a stable dose for 3 months

Sponsors & Collaborators

• Brown University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (1)

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Depression; Suicide; Suicidal Ideation; Suicide, Attempted

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Self-Injurious Behavior

Limitations and Caveats

The outcome data from this study must be considered within the context of its limitations including the small sample size which reduces both the power to detect differences between groups as well as the stability of findings.

Results Point of Contact

• Title: Anthony Spirito
• Organization: Brown University

anthony_spirito@brown.edu

401-444-1929

Study Officials

• Anthony Spirito, PhD

  Brown University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 4, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 31, 2015
• Results First Posted: August 31, 2015

Record last verified: 2015-03

Locations

US (1)