Suicidal and Self-injurious BehaviorED_SMARTNCT07092345
An Adaptive Intervention to Increase Engagement to Community-Based Care After an ED Admission
A study testing adaptive intervention in people with Suicidal and Self-injurious Behavior and Linkage to Care, run by Rhode Island Hospital at 1 site in United States.
Trial summary
The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Suicidal and Self-injurious Behavior, Linkage to Care
- What is being tested?
- adaptive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2025to Mar 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Youth 8 to 17 years
- Youth presenting to the ED with suicide and self-injurious behavior
- Youth living at home with at least one legal guardian/caregiver
Who cannot join
- Youth presenting to the ED with psychosis, sexual assault, child abuse
- Youth in police custody,
- Youth with an active investigation with the department of child and youth services (DCYF)
- Youth unable to assent due to severity of illness or developmental disabilities,
- Youth who cannot communicate in English or Spanish,
- Youth without a caregiver/legal guardian who can provide consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Mary Kathryn Cancilliere, PhD, 401-444-7443, marykathryn.cancilliere@brownhealth.org
About this study
Official title: An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior
The goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.
Read the detailed description
This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.
- Being tested
- adaptive intervention
- Keywords
- suicidality, self-injurious behavior, adaptive intervention, emergency department, caregivers, youth
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adaptive interventionBehavioural
We will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only.
| Study group | Role | What they receive |
|---|---|---|
| Psychosocial | Experimental | Digitally delivered psychosocial Receives: Behavioral: adaptive intervention |
| Psychosocial with text messages | Experimental | Digitally delivered psychosocial with text messages Receives: Behavioral: adaptive intervention |
| Psychosocial with text messages and family navigator | Experimental | Digitally delivered psychosocial with text messages and human family navigator Receives: Behavioral: adaptive intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility
Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)
Measured: 3-month & 6-month follow-up assessments
Child and Adolescent Service Assessment (CASA)
Youth Attendance to Community-based Mental Health Care. CASA question and caregiver report of youth attendance in behavioral health care/community-based mental health services (yes or no) after discharge from emergency department admission.
Measured: 3-month and 6-month follow-up assessments
Intervention Acceptability
Client Satisfaction Questionnaire. An 8-item questionnaire that provides (positive \& negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.
Measured: 3-month and 6-month follow-up assessments
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start17 Mar 2025
- Primary completionJan 2029 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Suicidal and Self-injurious BehaviorStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Adaptive intervention via Sequential Multiple Assignment Randomized Trial (SMART) design
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rhode Island Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07092345
- Sponsor's protocol ID
- 2037770
- Other IDs
- K23MH136332
- Acronym
- ED_SMART
- Status last verified
- Aug 2026
- First submitted
- 17 Mar 2025
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cancilliere MK, Ramanathan A, Hoffman P, Jencks J, Spirito A, Donise K. Characteristics of a Pediatric Emergency Psychiatric Telephone Triage Service. Pediatr Emerg Care. 2022 Oct 1;38(10):494-501. doi: 10.1097/PEC.0000000000002831. Epub 2022 Aug 18.
PubMed 35981327Spirito A, Simon V, Cancilliere MK, Stein R, Norcott C, Loranger K, Prinstein MJ. Outpatient psychotherapy practice with adolescents following psychiatric hospitalization for suicide ideation or a suicide attempt. Clin Child Psychol Psychiatry. 2011 Jan;16(1):53-64. doi: 10.1177/1359104509352893. Epub 2010 Apr 19.
PubMed 20404070Cancilliere MK, Donise K. A Comparison of Acute Mental Health Presentations to Emergency Services Before and During the COVID-19 Pandemic. R I Med J (2013). 2022 May 2;105(4):9-15.
PubMed 35476729Cancilliere MK, Guthrie KM, Donise K, Lin T, Orchowski L, Spirito A. Development of an Emergency Department Family Navigator and Text Message Intervention for Caregivers to Reduce Youth Risk of Suicide and Self-injurious Behavior. R I Med J (2013). 2024 Aug 1;107(8):28-38.
PubMed 39058987
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Adaptive Intervention to Increase Engagement to Community-based Care After an ED Admission: For Youth at Risk for Suicide and Self-injurious Behavior
- ClinicalTrials.gov ID
- NCT07092345
- Acronym / sponsor ID
- ED_SMART / 2037770
- Keywords
- suicidality, self-injurious behavior, adaptive intervention, emergency department, caregivers, youth
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 186 participants (estimated)
- Lead sponsor
- Rhode Island HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 17 Mar 2025 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Jul 2025 (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 goal of this study is to develop a feasible brief, family-based adaptive intervention, via SMART design, for youth with suicidal and non-suicidal self-injurious behavior (SSIB) to increase community-based mental health (MH) care attendance and reduce SSIB risk post emergency department (ED) admission. The intervention will focus to increase understanding on youth MH literacy, MH communication, and MH engagement. Integrating an adaptive intervention via a SMART design in the ED could address subsequent barriers to youth obtaining appropriate level of community-based MH care and therefore reduce ED readmissions.
Detailed description
This adaptive intervention allows for two stages of randomization to address treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only condition or the psychosocial with digital health communication via text messages condition. If after two weeks, youth are identified as non-response, then dyads will be re-randomized to 2nd-stage intervention(s) that will include the use of a family navigation model.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Adaptive intervention via Sequential Multiple Assignment Randomized Trial (SMART) design
| Arm | Type | Receives |
|---|---|---|
| Psychosocial | Experimental | Behavioral: adaptive interventionDigitally delivered psychosocial |
| Psychosocial with text messages | Experimental | Behavioral: adaptive interventionDigitally delivered psychosocial with text messages |
| Psychosocial with text messages and family navigator | Experimental | Behavioral: adaptive interventionDigitally delivered psychosocial with text messages and human family navigator |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Youth 8 to 17 years
- Youth presenting to the ED with suicide and self-injurious behavior
- Youth living at home with at least one legal guardian/caregiver
Key exclusion criteria (6 listed)
- Youth presenting to the ED with psychosis, sexual assault, child abuse
- Youth in police custody,
- Youth with an active investigation with the department of child and youth services (DCYF)
- Youth unable to assent due to severity of illness or developmental disabilities,
- Youth who cannot communicate in English or Spanish,
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 |
|---|---|---|
| adaptive interventionWe will utilize an adaptive interventions via Sequential Multiple Assignment Randomized Trial (SMART) design provide a tailored, stepped-care approach for the type, intensity, and dose of treatment, thus, providing the most intensive care to only those who need it, particularly treatment non-response. First, youth and caregivers (dyads) will be randomized to receive 1st-stage interventions in the ED, either the digital psychosocial-only (PS) condition or the psychosocial with digital health communication (PS+text) condition. If identified as non-response at 2-weeks, then dyads will be re-randomized to 2nd-stage intervention(s). Specifically, the PS condition non-responders will be re-randomized to the PS+text condition or the PS+text+FN condition. The 1st-stage PS+text condition non-responders will receive the PS+text+FN condition only. | Behavioural | Psychosocial, Psychosocial with text messages, Psychosocial with text messages and family navigator |
Primary outcome
Intervention Feasibility
Time frame: 3-month & 6-month follow-up assessments
Recruitment rate (% of ppl who agree to be in the study), Study completion (% of ppl who complete entire study)
Child and Adolescent Service Assessment (CASA)
Time frame: 3-month and 6-month follow-up assessments
Youth Attendance to Community-based Mental Health Care. CASA question and caregiver report of youth attendance in behavioral health care/community-based mental health services (yes or no) after discharge from emergency department admission.
Intervention Acceptability
Time frame: 3-month and 6-month follow-up assessments
Client Satisfaction Questionnaire. An 8-item questionnaire that provides (positive \& negative) feedback from user opinion. Higher scores = greater satisfaction with intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Background: PubMed 35981327Cancilliere MK, Ramanathan A, Hoffman P, Jencks J, Spirito A, Donise K. Characteristics of a Pediatric Emergency Psychiatric Telephone Triage Service. Pediatr Emerg Care. 2022 Oct 1;38(10):494-501. doi: 10.1097/PEC.0000000000002831. Epub 2022 Aug 18.
- Background: PubMed 20404070Spirito A, Simon V, Cancilliere MK, Stein R, Norcott C, Loranger K, Prinstein MJ. Outpatient psychotherapy practice with adolescents following psychiatric hospitalization for suicide ideation or a suicide attempt. Clin Child Psychol Psychiatry. 2011 Jan;16(1):53-64. doi: 10.1177/1359104509352893. Epub 2010 Apr 19.
- Background: PubMed 35476729Cancilliere MK, Donise K. A Comparison of Acute Mental Health Presentations to Emergency Services Before and During the COVID-19 Pandemic. R I Med J (2013). 2022 May 2;105(4):9-15.
- Background: PubMed 39058987Cancilliere MK, Guthrie KM, Donise K, Lin T, Orchowski L, Spirito A. Development of an Emergency Department Family Navigator and Text Message Intervention for Caregivers to Reduce Youth Risk of Suicide and Self-injurious Behavior. R I Med J (2013). 2024 Aug 1;107(8):28-38.
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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.
Hasbro Children's Hospital
Providence, United States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing adaptive intervention in people with Suicidal and Self-injurious Behavior and Linkage to Care, run by Rhode Island Hospital 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 6 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: looking for participants now, as of the sponsor's last update on 14 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intervention Feasibility (time frame: 3-month & 6-month follow-up assessments). The study lists 3 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 NCT07092345, which also lists 4 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 14 Aug 2026.