Trial Outcomes & Findings for Concurrent Treatment for Depressed Parents and DepressedAdolescents (NCT NCT00951821)
NCT ID: NCT00951821
Last Updated: 2015-08-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
24 participants
Primary outcome timeframe
12 months
Results posted on
2015-08-31
Participant Flow
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
16
|
8
|
|
Overall Study
COMPLETED
|
16
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Concurrent Treatment for Depressed Parents and DepressedAdolescents
Baseline characteristics by cohort
| Measure |
Concurrent Treatment
n=16 Participants
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
n=8 Participants
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
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
14.69 years
STANDARD_DEVIATION 1.78 • n=93 Participants
|
14.0 years
STANDARD_DEVIATION 1.69 • n=4 Participants
|
14.45 years
STANDARD_DEVIATION 1.72 • n=27 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=93 Participants
|
6 Participants
n=4 Participants
|
20 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=93 Participants
|
5 Participants
n=4 Participants
|
15 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
7 Participants
n=4 Participants
|
22 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=93 Participants
|
8 participants
n=4 Participants
|
24 participants
n=27 Participants
|
|
Beck Depression Inventory
|
29.32 units on a scale
n=93 Participants
|
19.13 units on a scale
n=4 Participants
|
24.65 units on a scale
n=27 Participants
|
|
Beck Suicide Ideation Scale
|
9.81 units on a scale
n=93 Participants
|
5.75 units on a scale
n=4 Participants
|
8.12 units on a scale
n=27 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: intent to treat
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.
Outcome measures
| Measure |
Concurrent Treatment
n=16 Participants
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
n=8 Participants
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
|
|---|---|---|
|
Beck Depression Inventory - Adolescent Report, Change in Symptom Level
|
-17.5 change in BDI (-60 to 60 possible range)
Standard Error 2.8
|
-14.1 change in BDI (-60 to 60 possible range)
Standard Error 3.4
|
SECONDARY outcome
Timeframe: Measured at 12 monthsPopulation: intent to treat
measure of suicidal ideation - scale ranges from 0 to 38 - higher scores indicate higher suicidal ideation. These data refer to adolescent respondents. The outcome is a change score so range is from -38 to 38.
Outcome measures
| Measure |
Concurrent Treatment
n=16 Participants
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
n=8 Participants
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
|
|---|---|---|
|
Beck Suicide Scale - Adolescent Response
|
-1.7 units on a scale
Standard Error 1.4
|
-2.1 units on a scale
Standard Error 1.3
|
Adverse Events
Concurrent Treatment
Serious events: 5 serious events
Other events: 2 other events
Deaths: 0 deaths
Adolescent Treatment Only
Serious events: 2 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Concurrent Treatment
n=16 participants at risk
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent treatment: 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
n=8 participants at risk
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
Adolescent treatment only: 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
|
|---|---|---|
|
Psychiatric disorders
Inpatient Hospitalization; ED visit
|
31.2%
5/16 • Number of events 7 • I year
|
25.0%
2/8 • Number of events 2 • I year
|
Other adverse events
| Measure |
Concurrent Treatment
n=16 participants at risk
Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy.
Concurrent treatment: 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
n=8 participants at risk
Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy.
Adolescent treatment only: 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
|
|---|---|---|
|
Psychiatric disorders
Behavior problems involving legal authorities
|
12.5%
2/16 • Number of events 2 • I year
|
12.5%
1/8 • Number of events 1 • I year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place