DepressionPhase 1INVESTNCT01732601
Intensive Outpatient Services for Teens
A Phase 1 study testing Intensive Outpatient CBT in people with Depression and Suicide, run by Brown University at 1 site in United States.
Trial summary
This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Depression, Suicide
- What is being tested?
- Intensive Outpatient CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2012to 1 Jan 2018
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Current Mood Disorder and suicidal ideation and one of the following
- NSSI
- Suicide Attempt
- Substance Use
Who cannot join
- Intelligence Quotient < 80
- Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
- Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intensive Outpatient Protocol for High Risk Suicidal Teens
This study will identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.
Read the detailed description
Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and inpatient psychiatric hospitalization in this country. These expensive contacts with the health care system effectively address acute suicidality for many adolescents but there is a significant subset of suicidal patients that have continued suicidality. This study will target teens that are at risk for re-hospitalization based on continued suicidal ideation, their mood and another risk factor such as self-harm or substance use. These risk factors have been shown to increase risk for continued suicidal behavior and expensive contacts with the health care system. This protocol has been designed to determine whether Intensive Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood disorder, suicidal ideation, and substance use, will result in better treatment outcomes compared to standard care in the community. The Intensive CBT condition will be delivered by a team of two licensed mental health therapists over the course of one year and will work with both the teen and parent. The standard care condition will receive treatment in the community. One hundred-and fifty adolescents (38 a year) will be recruited from several inpatient and partial hospital locations. Each adolescent will receive a thorough baseline assessment to determine whether they are appropriate for the study and will be assigned to either the Intensive CBT condition or treatment within the community. Both groups of teens will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing over time.
- Conditions
- Depression, Suicide
- Being tested
- Intensive Outpatient CBT, Standard Care
- Keywords
- Suicide Attempt, Suicidal Ideation, NSSI, Substance Use
- Medical subject headings
- Depression, Suicide, Suicide, Attempted, Suicidal Ideation, Substance-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive Outpatient CBTBehavioural
Also called Intensive CBT for High Risk Teens with a mood disorder
Sessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year.
Standard CareBehavioural
Also called Treatment as Usual
Treatment at step-down facilities
| Study group | Role | What they receive |
|---|---|---|
| Intensive Outpatient CBT | Experimental | Intensive CBT for both parents and adolescents as well as family sessions to increase communication. Receives: Behavioral: Intensive Outpatient CBT |
| Standard Care | Active comparator | Standard Treatment in the Community Receives: Behavioral: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Suicide attempts
Self-report by parents or teens of a suicide attempt occurring in the follow-up period
Measured: Measured at 18 months from Baseline
Secondary outcomes (1)
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
Depressed mood as determined by clinical interview
Measured: Measured at 18 months from Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2012 (estimated)
- Study start1 Sep 2012
- Primary completion1 Oct 2017
- Study completion1 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 140 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
- NCT01732601
- Sponsor's protocol ID
- 1R01MH097703-01
- Other IDs
- 1R01MH097703-01
- Acronym
- INVEST
- Status last verified
- Jan 2018
- First submitted
- 13 Nov 2012
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Esposito-Smythers C, Wolff JC, Liu RT, Hunt JI, Adams L, Kim K, Frazier EA, Yen S, Dickstein DP, Spirito A. Family-focused cognitive behavioral treatment for depressed adolescents in suicidal crisis with co-occurring risk factors: a randomized trial. J Child Psychol Psychiatry. 2019 Oct;60(10):1133-1141. doi: 10.1111/jcpp.13095. Epub 2019 Jul 21.
PubMed 31328281
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensive Outpatient Protocol for High Risk Suicidal Teens
- ClinicalTrials.gov ID
- NCT01732601
- Acronym / sponsor ID
- INVEST / 1R01MH097703-01
- Conditions
- Depression, Suicide
- Keywords
- Suicide Attempt, Suicidal Ideation, NSSI, Substance Use
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Brown UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 1 Jan 2018 (actual)
- First posted
- 26 Nov 2012 (estimated)
- Results
- Not posted in the source record
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 identify the effectiveness of an intensive treatment program for teens who are at high risk for harming themselves.
Detailed description
Suicidal ideation and behavior are the primary reasons for emergency psychiatric care and inpatient psychiatric hospitalization in this country. These expensive contacts with the health care system effectively address acute suicidality for many adolescents but there is a significant subset of suicidal patients that have continued suicidality. This study will target teens that are at risk for re-hospitalization based on continued suicidal ideation, their mood and another risk factor such as self-harm or substance use. These risk factors have been shown to increase risk for continued suicidal behavior and expensive contacts with the health care system. This protocol has been designed to determine whether Intensive Cognitive Behavioral Therapy (CBT), which was designed to treat adolescents with a mood disorder, suicidal ideation, and substance use, will result in better treatment outcomes compared to standard care in the community. The Intensive CBT condition will be delivered by a team of two licensed mental health therapists over the course of one year and will work with both the teen and parent. The standard care condition will receive treatment in the community. One hundred-and fifty adolescents (38 a year) will be recruited from several inpatient and partial hospital locations. Each adolescent will receive a thorough baseline assessment to determine whether they are appropriate for the study and will be assigned to either the Intensive CBT condition or treatment within the community. Both groups of teens will receive follow-up assessments at 6, 12, and 18 months to identify how they are doing over time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive Outpatient CBT | Experimental | Behavioral: Intensive Outpatient CBTIntensive CBT for both parents and adolescents as well as family sessions to increase communication. |
| Standard Care | Active comparator | Behavioral: Standard CareStandard Treatment in the Community |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Current Mood Disorder and suicidal ideation and one of the following
- NSSI
- Suicide Attempt
- Substance Use
Key exclusion criteria (3 listed)
- Intelligence Quotient < 80
- Diagnosis of psychotic disorder, pervasive developmental disorder, obsessive-compulsive disorder, bulimia nervosa or anorexia nervosa
- Adolescent use of illicit "hard" substances such as cocaine, heroine, and opiates 13 or more times over the prior 90 days
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 |
|---|---|---|
| Intensive Outpatient CBTAlso: Intensive CBT for High Risk Teens with a mood disorderSessions will be delivered 1-2 times a week for the first 4-6 weeks, based on need, and then weekly until 6 months. Therapy can continue up until one year. | Behavioural | Intensive Outpatient CBT |
| Standard CareAlso: Treatment as UsualTreatment at step-down facilities | Behavioural | Standard Care |
Primary outcome
Suicide attempts
Time frame: Measured at 18 months from Baseline
Self-report by parents or teens of a suicide attempt occurring in the follow-up period
1 secondary outcome
Depressed mood as assessed by the Children's Depression Rating Scale - Revised
Time frame: Measured at 18 months from Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Derived from this study: PubMed 31328281Esposito-Smythers C, Wolff JC, Liu RT, Hunt JI, Adams L, Kim K, Frazier EA, Yen S, Dickstein DP, Spirito A. Family-focused cognitive behavioral treatment for depressed adolescents in suicidal crisis with co-occurring risk factors: a randomized trial. J Child Psychol Psychiatry. 2019 Oct;60(10):1133-1141. doi: 10.1111/jcpp.13095. Epub 2019 Jul 21.
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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 Phase 1 study testing Intensive Outpatient CBT 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 4 inclusion and 3 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 23 Jan 2018. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Suicide attempts (time frame: Measured at 18 months from Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01732601, which also lists 1 linked publication.
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 23 Jan 2018.