Suicidal IdeationNCT03527459
Implementing an IPTS Treatment Approach to Improve Outcomes in Suicidal Youth
A study testing SPARC B and SPARC A in people with Suicidal Ideation and Depression, run by University of Texas Southwestern Medical Center at 1 site in United States.
Trial summary
The purpose of this project is to evaluate a set of interventions derived from a theory of suicide that supplements a clinical program and compare their effects on outcomes to the outcomes of the unsupplemented program. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicidal Ideation, Depression
- What is being tested?
- SPARC B and SPARC A
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 123 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2017to 1 Jun 2019
- Phase
- Interventional
- 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
- adolescents, ages 12 - 17
- enrolled in the SPARC program at Children's Medical Center of Dallas
- completed at least 5 SPARC group therapy sessions
Who cannot join
- adolescents who have previously received treatment in the control arm of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth
The purpose of this project is to evaluate a set of interventions derived from a theory of suicide that supplements a clinical program and compare their effects on outcomes to the outcomes of the unsupplemented program. This study proposes to evaluate the effect of these interventions on reducing specific negative cognitions associated with depression and suicide ideation in an intensive outpatient program for suicidal youth (Suicide Prevention and Resilience at Children's, SPARC).
Read the detailed description
The trial will be conducted in a program where half of the clients are enrolled into either the original program (SPARC A which has a general focus on negative cognitions) or SPARC B (which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness). The program is already structured so that each patient consistently attends either a morning or an afternoon track, with different therapists running each track. This allows for separate programs in each track. Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time. The investigators propose to take advantage of this partial introduction by assessing relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. The investigators have no data to indicate that one program will be better than the other. The investigation will, however, allow the investigators to assess whether this innovation in fact is effective. Patients will not be randomized at the individual level, but rather their time slot (usually decided based on opening within the program) will place them into either SPARC A or SPARC B. The two programs are of identical length with numerous features in common, differing only in the specificity of the exercises and examples and their relevance to perceived burdensomeness. Routine assessments at entry and discharge from the program will not change based on study enrollment. However, suicide ideation, depressive symptoms, and negative cognitions (perceived burdensomeness and thwarted belongingness) will be more formally assessed at the one-month follow-up meeting or phone call which will add approximately 10 minutes to the contact.
- Conditions
- Suicidal Ideation, Depression
- Being tested
- SPARC B, SPARC A
- Medical subject headings
- Suicidal Ideation, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPARC BBehavioural
SPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness.
SPARC ABehavioural
SPARC A is an existing clinical program with a general focus on negative cognitions.
| Study group | Role | What they receive |
|---|---|---|
| SPARC A | Active comparator | SPARC A is an existing clinical program which has a general focus on negative cognitions. Receives: Behavioral: SPARC A |
| SPARC B | Experimental | SPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions. Receives: Behavioral: SPARC B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
change in perceived burdensomeness
Measured: through program completion, an average of 6 weeks
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
suicide ideation (self-report)
Measured: through program completion, an average of 6 weeks
Secondary outcomes (5)
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
change in depressive symptoms
Measured: through program completion, an average of 6 weeks
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
change in perceived burdensomeness
Measured: 1 month after program completion
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
change in suicide ideation (self-report)
Measured: 1 month after program completion
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
change in depressive symptoms
Measured: 1 month after program completion
Concise Health Risk Tracking Self Report (CHRT-SR)
change in suicide ideation (self-report)
Measured: between program completion, an average of 6 weeks, and 1 month after program completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study start14 Nov 2017
- Primary completion7 Mar 2019
- Study completion1 Jun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Suicidal IdeationStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Half of the clients in the SPARC clinical program are enrolled into either the original program or SPARC B (which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness). The program is already structured so that each patient consistently attends either a morning or an afternoon track, with different therapists running each track. This allows for separate programs in each track. Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time. We will assess relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. Our investigation will allow us to assess whether this innovation is effective. Patients will not be randomized at the individual level, but rather their time slot (usually decided based on opening within the program) will place them into either SPARC A or SPARC B.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 123 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunita Stewart, University of Texas Southwestern Medical Center
- Investigators
- Sunita M. Stewart, PhD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527459
- Sponsor's protocol ID
- GA2016-010
- Status last verified
- Oct 2019
- First submitted
- 2 May 2018
- Last updated
- 1 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bernstein IH, Rush AJ, Trivedi MH, Hughes CW, Macleod L, Witte BP, Jain S, Mayes TL, Emslie GJ. Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents. Int J Methods Psychiatr Res. 2010 Dec;19(4):185-94. doi: 10.1002/mpr.321.
PubMed 20683845Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
PubMed 21733476Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19.
PubMed 21928908
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Implementing an Interpersonal Theory of Suicide Treatment Approach to Improve Outcomes in Suicidal Youth
- ClinicalTrials.gov ID
- NCT03527459
- Acronym / sponsor ID
- GA2016-010
- Conditions
- Suicidal Ideation, Depression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 123 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- 7 Mar 2019 (actual)
- Study completion
- 1 Jun 2019 (actual)
- First posted
- 17 May 2018 (actual)
- 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.
The purpose of this project is to evaluate a set of interventions derived from a theory of suicide that supplements a clinical program and compare their effects on outcomes to the outcomes of the unsupplemented program. This study proposes to evaluate the effect of these interventions on reducing specific negative cognitions associated with depression and suicide ideation in an intensive outpatient program for suicidal youth (Suicide Prevention and Resilience at Children's, SPARC).
Detailed description
The trial will be conducted in a program where half of the clients are enrolled into either the original program (SPARC A which has a general focus on negative cognitions) or SPARC B (which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness). The program is already structured so that each patient consistently attends either a morning or an afternoon track, with different therapists running each track. This allows for separate programs in each track. Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time. The investigators propose to take advantage of this partial introduction by assessing relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. The investigators have no data to indicate that one program will be better than the other. The investigation will, however, allow the investigators to assess whether this innovation in fact is effective. Patients will not be randomized at the individual level, but rather their time slot (usually decided based on opening within the program) will place them into either SPARC A or SPARC B. The two programs are of identical length with numerous features in common, differing only in the specificity of the exercises and examples and their relevance to perceived burdensomeness. Routine assessments at entry and discharge from the program will not change based on study enrollment. However, suicide ideation, depressive symptoms, and negative cognitions (perceived burdensomeness and thwarted belongingness) will be more formally assessed at the one-month follow-up meeting or phone call which will add approximately 10 minutes to the contact.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Half of the clients in the SPARC clinical program are enrolled into either the original program or SPARC B (which will overlap significantly with SPARC A but targets in some sessions specific negative cognitions of perceived burdensomeness). The program is already structured so that each patient consistently attends either a morning or an afternoon track, with different therapists running each track. This allows for separate programs in each track. Clinically justifiable innovations are routinely introduced into the program usually in a stepwise fashion in one or another part by one set of therapists at a time. We will assess relative impact of SPARC A and SPARC B on depressive symptoms and suicide ideation. Our investigation will allow us to assess whether this innovation is effective. Patients will not be randomized at the individual level, but rather their time slot (usually decided based on opening within the program) will place them into either SPARC A or SPARC B.
| Arm | Type | Receives |
|---|---|---|
| SPARC A | Active comparator | Behavioral: SPARC ASPARC A is an existing clinical program which has a general focus on negative cognitions. |
| SPARC B | Experimental | Behavioral: SPARC BSPARC B includes all aspects of the SPARC A clinical program, but targets negative cognitions of perceived burdensomeness in some sessions. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- adolescents, ages 12 - 17
- enrolled in the SPARC program at Children's Medical Center of Dallas
- completed at least 5 SPARC group therapy sessions
Key exclusion criteria (1 listed)
- adolescents who have previously received treatment in the control arm of the study
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 |
|---|---|---|
| SPARC BSPARC B includes all aspects of the SPARC A clinical program, as well as targeting negative cognitions of perceived burdensomeness. | Behavioural | SPARC B |
| SPARC ASPARC A is an existing clinical program with a general focus on negative cognitions. | Behavioural | SPARC A |
Primary outcome
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Time frame: through program completion, an average of 6 weeks
change in perceived burdensomeness
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Time frame: through program completion, an average of 6 weeks
suicide ideation (self-report)
5 secondary outcomes
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Time frame: through program completion, an average of 6 weeks
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012)
Time frame: 1 month after program completion
Concise Health Risk Tracking Self Report (CHRT-SR) (Trivedi et al., 2011)
Time frame: 1 month after program completion
Quick Inventory of Depressive Symptomatology - Adolescent Version Self-Report (QIDS-A-SR-16) (Bernstein et al., 2010)
Time frame: 1 month after program completion
Concise Health Risk Tracking Self Report (CHRT-SR)
Time frame: between program completion, an average of 6 weeks, and 1 month after program completion
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 1 Nov 2019.
- Background: PubMed 20683845Bernstein IH, Rush AJ, Trivedi MH, Hughes CW, Macleod L, Witte BP, Jain S, Mayes TL, Emslie GJ. Psychometric properties of the Quick Inventory of Depressive Symptomatology in adolescents. Int J Methods Psychiatr Res. 2010 Dec;19(4):185-94. doi: 10.1002/mpr.321.
- Background: PubMed 21733476Trivedi MH, Wisniewski SR, Morris DW, Fava M, Gollan JK, Warden D, Nierenberg AA, Gaynes BN, Husain MM, Luther JF, Zisook S, Rush AJ. Concise Health Risk Tracking scale: a brief self-report and clinician rating of suicidal risk. J Clin Psychiatry. 2011 Jun;72(6):757-64. doi: 10.4088/JCP.11m06837.
- Background: PubMed 21928908Van Orden KA, Cukrowicz KC, Witte TK, Joiner TE. Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the Interpersonal Needs Questionnaire. Psychol Assess. 2012 Mar;24(1):197-215. doi: 10.1037/a0025358. Epub 2011 Sep 19.
- Individual participant dataSharing planned: No
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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.
Sunita M. Stewart, PhD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SPARC B and SPARC A in people with Suicidal Ideation and Depression, run by University of Texas Southwestern Medical Center 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 3 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 1 Nov 2019. 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?
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?
Interpersonal Needs Questionnaire (INQ) (Van Orden et al., 2012) (time frame: through program completion, an average of 6 weeks). The study lists 2 primary outcomes in all. 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 NCT03527459, which also lists 3 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 1 Nov 2019; AzTrials last refreshed its copy on 6 Nov 2026.