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| ID | Type | Description | Link |
|---|---|---|---|
| R34MH082211 | U.S. NIH Grant/Contract | View source | |
| DSIR 84 CTS | |||
| NCT00951821 | Registry Identifier | Clinical Trials.Gov |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Concurrent treatment | Experimental | Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy. |
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| Adolescent treatment only | Active Comparator | Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at 12 months |
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Inclusion Criteria for Adolescents:
Inclusion Criteria for Primary Caretakers:
Exclusion Criteria for Adolescents:
Exclusion Criteria for Primary Caretakers:
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| Name | Affiliation | Role |
|---|---|---|
| Anthony Spirito, PhD | Brown University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brown University | Providence | Rhode Island | 02912 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | intent to treat | Posted | Mean | Standard Error | change in BDI (-60 to 60 possible range) | 12 months |
|
I year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Concurrent Treatment | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Inpatient Hospitalization; ED visit | Psychiatric disorders | Non-systematic Assessment | Evaluated or admitted secondary to suicidal ideation and/or behavior |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Behavior problems involving legal authorities | Psychiatric disorders | Non-systematic Assessment | Fire setting; vanda,ism |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anthony Spirito | Brown University | 401-444-1929 | anthony_spirito@brown.edu |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D013405 | Suicide |
| D059020 | Suicidal Ideation |
| D013406 | Suicide, Attempted |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D016728 | Self-Injurious Behavior |
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| 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 |
|
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | A standard self-report form was used for adolescents to self-identify race and ethnicity | Count of Participants | Participants |
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| Region of Enrollment | Northeast | Number | participants |
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| Beck Depression Inventory | Higher scores indicate greater depression; full range 0 to 60. | Mean | Full Range | units on a scale |
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| Beck Suicide Ideation Scale | Higher scores indicate greater suicidal ideation; full range 0 to 38 | Mean | Full Range | units on a scale |
|
| OG001 | 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 |
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| 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. | intent to treat | Posted | Mean | Standard Error | units on a scale | Measured at 12 months |
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| 5 |
| 16 |
| 2 |
| 16 |
| EG001 | Adolescent Treatment Only | 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 | 2 | 8 | 1 | 8 |
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