Depression, Suicide
Conditions
Keywords
Suicidal Ideation, Suicide Attempts
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.
Detailed description
Depression, like many psychiatric disorders, has a genetic component that makes it more likely that members of the same family will have the disorder. Depression in parents, particularly mothers, may put the children at greater risk for depression. When an adolescent whose parent is depressed develops depression himself or herself, treating both the parent and the adolescent may be more effective than treating only the adolescent. This study will test a depression treatment that targets depressed suicidal adolescents with a parent or primary caretaker who is also depressed and has a history of suicidality. Participation in this study will last 6 months. Participants will be randomly assigned to receive either concurrent parent and adolescent treatment or adolescent only treatment. For those assigned to concurrent treatment, both the adolescent participants and one of their parents will receive individual cognitive behavioral therapy (CBT) counseling sessions and joint family counseling sessions. In the adolescent only treatment condition, adolescent participants will receive individual CBT sessions, but parents will not, and both will receive joint family sessions. Counseling sessions will last 1 hour and occur weekly for 3 months, and then every other week for 3 months. CBT identifies and attempts to change problematic thought patterns. All participants will receive medication consultation if necessary. Participants will complete assessments at baseline, post-treatment, and 6 months after completing treatment. These assessments will include questionnaires and interviews about depression, suicidal thoughts, mood regulation, behavioral problems, and family. At post-treatment and the 6-month follow-up, participants will also be asked to give feedback about the counseling, medication consultation, and their satisfaction.
Interventions
BEHAVIORALConcurrent 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.
BEHAVIORALAdolescent 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
Sponsors
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
for Adolescents: * 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) Inclusion Criteria for Primary Caretakers: * Speaks English * Current diagnosis of MDD and a history of suicidality
Exclusion criteria
for Adolescents: * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Beck Depression Inventory - Adolescent Report, Change in Symptom Level | 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Suicide Scale - Adolescent Response | Measured at 12 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 16 |
| 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 | 8 |
| Total | 24 |
Baseline characteristics
| Characteristic | Concurrent Treatment | Total | Adolescent Treatment Only |
|---|---|---|---|
| Age, Continuous | 14.69 years STANDARD_DEVIATION 1.78 | 14.45 years STANDARD_DEVIATION 1.72 | 14.0 years STANDARD_DEVIATION 1.69 |
| Beck Depression Inventory | 29.32 units on a scale | 24.65 units on a scale | 19.13 units on a scale |
| Beck Suicide Ideation Scale | 9.81 units on a scale | 8.12 units on a scale | 5.75 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 22 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 5 Participants | 2 Participants |
| Race (NIH/OMB) White | 10 Participants | 15 Participants | 5 Participants |
| Region of Enrollment United States | 16 participants | 24 participants | 8 participants |
| Sex: Female, Male Female | 14 Participants | 20 Participants | 6 Participants |
| Sex: Female, Male Male | 2 Participants | 4 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 2 / 16 | 1 / 8 |
| serious Total, serious adverse events | 5 / 16 | 2 / 8 |
Outcome results
Primary
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.
Time frame: 12 months
Population: intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Concurrent Treatment | Beck Depression Inventory - Adolescent Report, Change in Symptom Level | -17.5 change in BDI (-60 to 60 possible range) | Standard Error 2.8 |
| Adolescent Treatment Only | Beck Depression Inventory - Adolescent Report, Change in Symptom Level | -14.1 change in BDI (-60 to 60 possible range) | Standard Error 3.4 |
p-value: 0.4695% CI: [-12.1, 5.5]Mixed Models Analysis
Secondary
Beck Suicide Scale - Adolescent Response
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.
Time frame: Measured at 12 months
Population: intent to treat
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Concurrent Treatment | Beck Suicide Scale - Adolescent Response | -1.7 units on a scale | Standard Error 1.4 |
| Adolescent Treatment Only | Beck Suicide Scale - Adolescent Response | -2.1 units on a scale | Standard Error 1.3 |
p-value: 0.7595% CI: [-2.36, 3.06]Mixed Models Analysis