Suicide, AttemptedPhase 2NCT00071617
Youth-Nominated Support Team Intervention for Suicidal Adolescents
A Phase 2 study testing Youth-Nominated Support Team in people with Suicide, Attempted, run by University of Michigan at 1 site in United States.
Trial summary
This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide. Read more about this study
- Who is it for?
- Ages 13 to 17 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Youth-Nominated Support Team
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 448 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2002to Dec 2008
- Phase
- Phase 2
- 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 13 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Hospitalization in a participating psychiatric facility
- Suicidal ideation, intent, or attempt
Who cannot join
- Severe physical or cognitive impairment that makes informed consent, nominations, or participation in assessments impossible
Trial locations and contacts
1 site in 1 country.
United States1 site
Child and Adolescent Psychiatry Hospital, University of Michigan
Ann Arbor, Michigan, 48109
About this study
Official title: Youth Support Team Intervention for Suicidal Adolescents
This study will attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.
Read the detailed description
Despite substantial knowledge about adolescent suicide risk factors, few studies have been conducted to identify effective interventions for suicidal adolescents.
Youth-Nominated Support Team (YST) is an intervention designed to help suicidal adolescents after hospitalization. It is a psychoeducational social network intervention that targets poor treatment adherence and difficulties with social support. YST is designed to be a supplement to traditional or usual treatments.
Participants are randomly assigned to receive either treatment as usual (TAU) or TAU plus YST for 3 months. Adolescents who receive TAU plus YST nominate three or four adults from their family, school, and community settings to function as support persons. The support persons participate in a psychoeducation session that focuses on the adolescent's psychiatric disorder(s), individualized treatment plan, importance of treatment adherence, and suicide risk factors. They also maintain regular contact with the adolescent to support treatment adherence and progress toward treatment goals. Adolescents have assessments at 6 weeks, 3 months, 6 months, and 12 months. Internalizing behavior problems, perceived social support, treatment adherence, adaptive functioning, severity of depression and anxiety, severity and frequency of suicidal thoughts, and suicide attempts are assessed.
- Conditions
- Suicide, Attempted
- Being tested
- Youth-Nominated Support Team
- Keywords
- Suicide, Adolescence
- Medical subject headings
- Suicide, Attempted, Suicide
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Youth-Nominated Support TeamBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Youth-Nominated Support Team | Experimental | Adolescents nominate up to 4 caring adults from family, school, community settings. These adults participate in psychoeducation sessions regarding adolescent's treatment plan and support needs. They maintain regular, supportive contact with the adolescent for 3 months -- with ongoing consultation and support check-ins from study clinical staff. Receives: Behavioral: Youth-Nominated Support Team |
| Enhanced Treatment as Usual | No intervention | Adolescents in this condition receive study assessments and risk management services (at time of assessments) only |
What is being measured
The primary outcome is the main question the study is designed to answer.
suicidal ideation - Suicidal Ideation Questionnaire-JR
Type, frequency, and severity of suicidal thoughts
Measured: 3 month
Secondary outcomes (1)
Depression - Children's Depression Rating Scale-Revised
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2003 (estimated)
- Study startNov 2002
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 448 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cheryl A. King, University of Michigan
- Investigators
- Cheryl A. King, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00071617
- Sponsor's protocol ID
- R01MH063881
- Other IDs
- R01MH063881, DSIR 84-CTS
- Status last verified
- Nov 2013
- First submitted
- 29 Oct 2003
- Last updated
- 11 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
PubMed 33677832King CA, Arango A, Kramer A, Busby D, Czyz E, Foster CE, Gillespie BW; YST Study Team. Association of the Youth-Nominated Support Team Intervention for Suicidal Adolescents With 11- to 14-Year Mortality Outcomes: Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2019 May 1;76(5):492-498. doi: 10.1001/jamapsychiatry.2018.4358.
PubMed 30725077
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Youth Support Team Intervention for Suicidal Adolescents
- ClinicalTrials.gov ID
- NCT00071617
- Acronym / sponsor ID
- R01MH063881
- Conditions
- Suicide, Attempted
- Keywords
- Suicide, Adolescence
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 448 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Nov 2002
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 30 Oct 2003 (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 attempt to improve treatment adherence and reduce suicide risk among adolescents who are at risk for attempting suicide.
Detailed description
Despite substantial knowledge about adolescent suicide risk factors, few studies have been conducted to identify effective interventions for suicidal adolescents.
Youth-Nominated Support Team (YST) is an intervention designed to help suicidal adolescents after hospitalization. It is a psychoeducational social network intervention that targets poor treatment adherence and difficulties with social support. YST is designed to be a supplement to traditional or usual treatments.
Participants are randomly assigned to receive either treatment as usual (TAU) or TAU plus YST for 3 months. Adolescents who receive TAU plus YST nominate three or four adults from their family, school, and community settings to function as support persons. The support persons participate in a psychoeducation session that focuses on the adolescent's psychiatric disorder(s), individualized treatment plan, importance of treatment adherence, and suicide risk factors. They also maintain regular contact with the adolescent to support treatment adherence and progress toward treatment goals. Adolescents have assessments at 6 weeks, 3 months, 6 months, and 12 months. Internalizing behavior problems, perceived social support, treatment adherence, adaptive functioning, severity of depression and anxiety, severity and frequency of suicidal thoughts, and suicide attempts are assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Youth-Nominated Support Team | Experimental | Behavioral: Youth-Nominated Support TeamAdolescents nominate up to 4 caring adults from family, school, community settings. These adults participate in psychoeducation sessions regarding adolescent's treatment plan and support needs. They maintain regular, supportive contact with the adolescent for 3 months -- with ongoing consultation and support check-ins from study clinical staff. |
| Enhanced Treatment as Usual | No intervention | –Adolescents in this condition receive study assessments and risk management services (at time of assessments) only |
Who may qualify
- Ages
- 13 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Hospitalization in a participating psychiatric facility
- Suicidal ideation, intent, or attempt
Key exclusion criteria (1 listed)
- Severe physical or cognitive impairment that makes informed consent, nominations, or participation in assessments impossible
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 |
|---|---|---|
| Youth-Nominated Support Team | Behavioural | Youth-Nominated Support Team |
Primary outcome
suicidal ideation - Suicidal Ideation Questionnaire-JR
Time frame: 3 month
Type, frequency, and severity of suicidal thoughts
1 secondary outcome
Depression - Children's Depression Rating Scale-Revised
Time frame: 3 months
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 11 Nov 2013.
- Derived from this study: PubMed 33677832Witt KG, Hetrick SE, Rajaram G, Hazell P, Taylor Salisbury TL, Townsend E, Hawton K. Interventions for self-harm in children and adolescents. Cochrane Database Syst Rev. 2021 Mar 7;3(3):CD013667. doi: 10.1002/14651858.CD013667.pub2.
- Derived from this study: PubMed 30725077King CA, Arango A, Kramer A, Busby D, Czyz E, Foster CE, Gillespie BW; YST Study Team. Association of the Youth-Nominated Support Team Intervention for Suicidal Adolescents With 11- to 14-Year Mortality Outcomes: Secondary Analysis of a Randomized Clinical Trial. JAMA Psychiatry. 2019 May 1;76(5):492-498. doi: 10.1001/jamapsychiatry.2018.4358.
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Suicide
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.
Cheryl A. King, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Youth-Nominated Support Team in people with Suicide, Attempted, run by University of Michigan 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 2 inclusion and 1 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 11 Nov 2013. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
suicidal ideation - Suicidal Ideation Questionnaire-JR (time frame: 3 month). 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 NCT00071617, which also lists 2 linked publications.
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 11 Nov 2013.