DepressionNCT00951821
Concurrent Treatment for Depressed Parents and DepressedAdolescents
A study testing Concurrent treatment and Adolescent treatment only in people with Depression and Suicide, run by Brown University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Depression, Suicide
- What is being tested?
- Concurrent treatment and Adolescent treatment only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2009to Dec 2013
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
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.
Read the 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.
- Conditions
- Depression, Suicide
- Being tested
- Concurrent treatment, Adolescent treatment only
- Keywords
- Suicidal Ideation, Suicide Attempts
- Medical subject headings
- Depression, Suicide, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Concurrent treatmentBehavioural
Also called CBT for adolescents and parents
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 onlyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Concurrent treatment | Experimental | Concurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy. Receives: Behavioral: Concurrent treatment |
| Adolescent treatment only | Active comparator | Adolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy. Receives: Behavioral: Adolescent treatment only |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (1)
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: Measured at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by Brown UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brown University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Anthony Spirito, Brown University
- Investigators
- Anthony Spirito, PhD, Principal investigator, Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00951821
- Sponsor's protocol ID
- R34MH082211
- Other IDs
- R34MH082211, DSIR 84 CTS, NCT00951821
- Status last verified
- Mar 2015
- First submitted
- 3 Aug 2009
- Last updated
- 31 Aug 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concurrent Treatment for Parents and Adolescents Who Attempt Suicide
- ClinicalTrials.gov ID
- NCT00951821
- Acronym / sponsor ID
- R34MH082211
- Conditions
- Depression, Suicide
- Keywords
- Suicidal Ideation, Suicide Attempts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2009
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Aug 2009 (estimated)
- Results
- Posted 31 Aug 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Concurrent treatment | Experimental | Behavioral: Concurrent treatmentConcurrent treatment - experimental condition: Adolescent participants and their parents will receive concurrent cognitive behavioral therapy. |
| Adolescent treatment only | Active comparator | Behavioral: Adolescent treatment onlyAdolescent treatment only - Active Comparator: Only adolescent participants will receive cognitive behavioral therapy. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Concurrent treatmentAlso: CBT for adolescents and parentsIndividual 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. | Behavioural | Concurrent treatment |
| Adolescent treatment onlyIndividual 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 | Behavioural | Adolescent treatment only |
Primary outcome
Beck Depression Inventory - Adolescent Report, Change in Symptom Level
Time frame: 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.
1 secondary outcome
Beck Suicide Scale - Adolescent Response
Time frame: Measured at 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Depression
Recruiting
Unified Protocol in Penitentiary Facilities
Depression Disorders, Anxiety
Not yet recruiting
Preventive and Personalized Digital Emotion Regulation Skills Intervention to Reduce Depression and Anxiety in Youths With Adverse Childhood Experiences
Adverse Childhood Experience, Depression / Major Depressive Disorder
Not yet recruitingObservational study
Functional Impact of Psychological Symptoms in Patients With Superior Semicircular Canal Dehiscence Syndrome (SSCD): a National Cross-sectional Study
Superior Semicircular Canal Dehiscence
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Recruiting
Cultural Adaptation of an Online Parenting Intervention to Reduce the Risk of Depression and Anxiety in Adolescents
Risk of Depression and Anxiety
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anthony Spirito, PhD principal investigator
Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concurrent treatment and Adolescent treatment only in people with Depression and Suicide, run by Brown University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beck Depression Inventory - Adolescent Report, Change in Symptom Level (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2015.