Concurrent Treatment for Depressed Parents and DepressedAdolescents

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Anthony Spirito, Brown University
ClinicalTrials.gov Identifier:
NCT00951821
First received: August 3, 2009
Last updated: August 4, 2015
Last verified: March 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Depression
Suicide
Interventions: Behavioral: Concurrent treatment
Behavioral: Adolescent treatment only

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Concurrent Treatment

Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.

Concurrent cognitive behavioral therapy (CBT): 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.

Adolescent Treatment Only

Only adolescent participants will receive cognitive behavioral therapy.

Adolescent only cognitive behavioral therapy (CBT): 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


Participant Flow:   Overall Study
    Concurrent Treatment     Adolescent Treatment Only  
STARTED     16     8  
COMPLETED     16     8  
NOT COMPLETED     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Concurrent Treatment

Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.

Concurrent cognitive behavioral therapy (CBT): 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.

Adolescent Treatment Only

Only adolescent participants will receive cognitive behavioral therapy.

Adolescent only cognitive behavioral therapy (CBT): 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

Total Total of all reporting groups

Baseline Measures
    Concurrent Treatment     Adolescent Treatment Only     Total  
Number of Participants  
[units: participants]
  16     8     24  
Age  
[units: years]
Mean (Standard Deviation)
  14.69  (1.78)     14.0  (1.69)     14.45  (1.72)  
Gender  
[units: participants]
     
Female     14     6     20  
Male     2     2     4  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     0     0  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     1     0     1  
White     10     5     15  
More than one race     2     1     3  
Unknown or Not Reported     3     2     5  
Ethnicity (NIH/OMB) [1]
[units: participants]
     
Hispanic or Latino     1     1     2  
Not Hispanic or Latino     15     7     22  
Unknown or Not Reported     0     0     0  
Region of Enrollment [2]
[units: participants]
     
United States     16     8     24  
Beck Depression Inventory [3]
[units: units on a scale]
Mean (Full Range)
  29.32   (8 to 49)     19.13   (14 to 30)     24.65   (8 to 49)  
Beck Suicide Ideation Scale [4]
[units: units on a scale]
Mean (Full Range)
  9.81   (1 to 29)     5.75   (0 to 15)     8.12   (0 to 29)  
[1] A standard self-report form was used for adolescents to self-identify race and ethnicity
[2] Northeast
[3] Higher scores indicate greater depression; full range 0 to 60.
[4] Higher scores indicate greater suicidal ideation; full range 0 to 38



  Outcome Measures
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1.  Primary:   Beck Depression Inventory - Adolescent Report, Change in Symptom Level   [ Time Frame: 12 months ]

2.  Secondary:   Beck Suicide Scale - Adolescent Response   [ Time Frame: Measured at 12 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Anthony Spirito
Organization: Brown University
phone: 401-444-1929
e-mail: anthony_spirito@brown.edu



Responsible Party: Anthony Spirito, Brown University
ClinicalTrials.gov Identifier: NCT00951821     History of Changes
Other Study ID Numbers: R34MH082211 ( US NIH Grant/Contract Award Number )
DSIR 84 CTS
Study First Received: August 3, 2009
Results First Received: February 20, 2015
Last Updated: August 4, 2015
Health Authority: United States: Federal Government