Suicide, AttemptedNCT05340296
Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
A study testing Acute Youth Connect in people with Suicide, Attempted, run by University of Rochester at 1 site in United States.
Trial summary
The purpose of this pilot study is to refine and then assess the feasibility, acceptability, and target engagement of Acute Youth Connect - a network health intervention for adolescents leaving acute psychiatric care with suicide-related concerns. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Suicide, Attempted
- What is being tested?
- Acute Youth Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2022to 6 Oct 2023
- 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
Youth subjects will be included if:
- Youth subject is being discharged from the Child and Adolescent Partial Hospital Service (CAPHS) in the URMC Department of Psychiatry.
- Youth subject endorses past year suicide attempt OR past year suicidal ideation at time of partial hospitalization, as assessed on standardized intake questionnaire used by CAPHS.
- Youth subject has a cellular phone, with an active service plan, that is capable of sending and receiving standard SMS text messages.
- Youth subject is aged 12 - 18 at time of enrollment.
Youth subjects will be excluded if:
- Youth subject has medical or psychiatric comorbidities that impair ability to assent (e.g., active psychotic or manic episode, cognitive impairment).
- Youth subject patient or guardian does not speak fluent English, as meeting translation costs is not possible in this study.
- Youth subject is unable to name at least 2 trusted adults (at least 1 of which is not a parent or caregiver) they would like to serve on their support team.
- Youth is unable or unwilling to share their suicide-related safety plan
Parent / legal guardian subjects will be included if:
- Adult subject is at least 21 years of age.
Adult support team subjects will be included if:
- Adult subject is nominated by a youth subject to serve on their adult support team
- Adult subject is approved by youth subject's parent or legal guardian
- Adult subject has a cellular phone, with an active service plan, that is capable of sending and receiving standard SMS text messages.
- Adult subject is at least 21 years of age.
Adult support team subjects will be excluded if:
- Adult subject has medical or psychiatric comorbidities that impair ability to consent (e.g., active psychotic or manic episode, cognitive impairment).
- Adult subject does not speak fluent English, as meeting translation costs is not possible in this study.
- Adult reports being unable to be in contact with youth at least once per week, for the 12 weeks of the intervention
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
The purpose of this pilot study is to refine and then assess the feasibility, acceptability, and target engagement of Acute Youth Connect - a network health intervention for adolescents leaving acute psychiatric care with suicide-related concerns.
Read the detailed description
This pilot study includes only one arm of subjects, all of whom will receive Acute Youth Connect, in addition to treatment as usual. The Acute Youth Connect treatment protocol lasts for 12 weeks following discharge, for a total intervention period of roughly 13 weeks including pre-discharge consent and nomination of supports. Patients will be assessed at baseline, mid-intervention, immediately post-intervention, and 12 weeks following the scheduled intervention completion.
Feedback from the first 5-10 patients will be used to modify the treatment protocol to improve patient acceptability. All remaining patients will receive this refined treatment protocol.
At the time of registration, the Acute Youth Connect treatment protocol is as follows. Adolescents in acute psychiatric care (partial hospitalization) will be screened for eligibility approximately one week before discharge. After patient assent and parental consent are received, the patient and a parent/caregiver will together nominate 3-4 trusted adults in the patient's life to serve as a post-discharge support team. The nominees will then be contacted, consented, and receive a 45-90 minute training on how to provide social support to the patient. Each adult support will also receive weekly (3-15 minute) check in calls from study staff to monitor progress and resolve any concerns related to the patient's progress. In addition, each patient will attend 3 interactive sessions with a study interventionist, and will be encouraged to bring an adult from their support team to participate as well. These sessions will be evenly spaced throughout the post-discharge intervention period. Adolescents will receive weekly reflection-prompting text messages to practice skills taught in the interactive sessions.
- Conditions
- Suicide, Attempted
- Being tested
- Acute Youth Connect
- Keywords
- suicide, suicide attempt, suicide ideation, adolescent, social network
- 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.
Acute Youth ConnectBehavioural
This intervention is being piloted will be revised with feedback from the first 5-10 patients who complete it. At the time of registration, the protocol is as follows: Roughly one week prior to discharge, the patient and a parent/caregiver will together nominate 3-4 trusted adults in the patient's life to serve as their post-discharge support team. Consenting nominees will then attend a 45-90 minute training on how to provide social support to the patient. Each adult support will also receive weekly (3-15 minute) check in calls from study staff to monitor progress and concerns. Each patient will also attend 3 interactive sessions with a study interventionist, and will be encouraged to bring an adult from their support team. These sessions will be evenly spaced throughout the post-discharge intervention period. Adolescents will receive weekly reflection-prompting text messages to practice skills taught in the interactive sessions.
| Study group | Role | What they receive |
|---|---|---|
| Acute Youth Connect + TAU | Experimental | Subjects will receive 12 weeks of post-discharge Acute Youth Connect intervention, in addition to regular post-discharge treatment as usual. Receives: Behavioral: Acute Youth Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of youth who complete the intervention
Youth subjects who complete all three interactive sessions will be marked as "treatment completers."
Measured: Interactive sessions by the end of the 12-week intervention.
Text message responses
Text message prompts will be marked as "responded to" when a recipient produces at least one reply.
Measured: A text message must be responded to before the next text message prompt is sent (roughly one week).
Adult support team treatment completion
Adult support team members who complete their initial psychoeducation training session and complete 75% of their check-in phone calls will be marked as "treatment completers".
Measured: Psychoeducation sessions must be completed before week 4 after youth's discharge. Check-in calls must be completed in seperatecalendar weeks, all before the end of the 12-week intervention.
Secondary outcomes (4)
Change in weekly contact to supportive adults in their lives
Youth subjects will report a change in the average weekly contact with the members of their adult support team, compared to reported baseline contact.
Measured: Baseline to post-treatment, approximately 3 months
Change in weekly contact to supportive adults in their lives
Youth subjects will report a change in the average weekly contact with the members of their adult support team, compared to reported baseline contact.
Measured: Baseline to 3 months post-treatment, approximately 6 months
Utilization of intervention content
Rate of adolescents reporting using at least two of the three Acute Youth Connect cores (connection, balance, purpose) weekly or more.
Measured: Baseline to post-treatment, approximately 3 months
Utilization of intervention content
Rate of adolescents reporting using at least two of the three Acute Youth Connect cores (connection, balance, purpose) weekly or more.
Measured: Baseline to 3 months post-treatment, approximately 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2022
- Study start1 Jul 2022
- Primary completion6 Oct 2023
- Study completion6 Oct 2023
Why it stopped: No funds remained for additional recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Suicide, AttemptedStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- Not applicable
- Intervention model
- Single group
- Model description
- All subjects will receive Acute Youth Connect plus treatment as usual.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Responsible party
- Principal investigator, Ian Cero, University of Rochester
- Investigators
- Ian Cero, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05340296
- Sponsor's protocol ID
- STUDY00006651
- Other IDs
- 2KL2TR001999-05, https://osf.io/8pd54/
- Status last verified
- Apr 2024
- First submitted
- 3 Mar 2022
- Last updated
- 16 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no current plan to share IPD with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
- ClinicalTrials.gov ID
- NCT05340296
- Acronym / sponsor ID
- STUDY00006651
- Conditions
- Suicide, Attempted
- Keywords
- suicide, suicide attempt, suicide ideation, adolescent, social network
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No funds remained for additional recruitment
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Advancing Translational Sciences (NCATS)
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 6 Oct 2023 (actual)
- First posted
- 22 Apr 2022 (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 pilot study is to refine and then assess the feasibility, acceptability, and target engagement of Acute Youth Connect - a network health intervention for adolescents leaving acute psychiatric care with suicide-related concerns.
Detailed description
This pilot study includes only one arm of subjects, all of whom will receive Acute Youth Connect, in addition to treatment as usual. The Acute Youth Connect treatment protocol lasts for 12 weeks following discharge, for a total intervention period of roughly 13 weeks including pre-discharge consent and nomination of supports. Patients will be assessed at baseline, mid-intervention, immediately post-intervention, and 12 weeks following the scheduled intervention completion.
Feedback from the first 5-10 patients will be used to modify the treatment protocol to improve patient acceptability. All remaining patients will receive this refined treatment protocol.
At the time of registration, the Acute Youth Connect treatment protocol is as follows. Adolescents in acute psychiatric care (partial hospitalization) will be screened for eligibility approximately one week before discharge. After patient assent and parental consent are received, the patient and a parent/caregiver will together nominate 3-4 trusted adults in the patient's life to serve as a post-discharge support team. The nominees will then be contacted, consented, and receive a 45-90 minute training on how to provide social support to the patient. Each adult support will also receive weekly (3-15 minute) check in calls from study staff to monitor progress and resolve any concerns related to the patient's progress. In addition, each patient will attend 3 interactive sessions with a study interventionist, and will be encouraged to bring an adult from their support team to participate as well. These sessions will be evenly spaced throughout the post-discharge intervention period. Adolescents will receive weekly reflection-prompting text messages to practice skills taught in the interactive sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All subjects will receive Acute Youth Connect plus treatment as usual.
| Arm | Type | Receives |
|---|---|---|
| Acute Youth Connect + TAU | Experimental | Behavioral: Acute Youth ConnectSubjects will receive 12 weeks of post-discharge Acute Youth Connect intervention, in addition to regular post-discharge treatment as usual. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
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 |
|---|---|---|
| Acute Youth ConnectThis intervention is being piloted will be revised with feedback from the first 5-10 patients who complete it. At the time of registration, the protocol is as follows: Roughly one week prior to discharge, the patient and a parent/caregiver will together nominate 3-4 trusted adults in the patient's life to serve as their post-discharge support team. Consenting nominees will then attend a 45-90 minute training on how to provide social support to the patient. Each adult support will also receive weekly (3-15 minute) check in calls from study staff to monitor progress and concerns. Each patient will also attend 3 interactive sessions with a study interventionist, and will be encouraged to bring an adult from their support team. These sessions will be evenly spaced throughout the post-discharge intervention period. Adolescents will receive weekly reflection-prompting text messages to practice skills taught in the interactive sessions. | Behavioural | Acute Youth Connect + TAU |
Primary outcome
Number of youth who complete the intervention
Time frame: Interactive sessions by the end of the 12-week intervention.
Youth subjects who complete all three interactive sessions will be marked as "treatment completers."
Text message responses
Time frame: A text message must be responded to before the next text message prompt is sent (roughly one week).
Text message prompts will be marked as "responded to" when a recipient produces at least one reply.
Adult support team treatment completion
Time frame: Psychoeducation sessions must be completed before week 4 after youth's discharge. Check-in calls must be completed in seperatecalendar weeks, all before the end of the 12-week intervention.
Adult support team members who complete their initial psychoeducation training session and complete 75% of their check-in phone calls will be marked as "treatment completers".
4 secondary outcomes
Change in weekly contact to supportive adults in their lives
Time frame: Baseline to post-treatment, approximately 3 months
Change in weekly contact to supportive adults in their lives
Time frame: Baseline to 3 months post-treatment, approximately 6 months
Utilization of intervention content
Time frame: Baseline to post-treatment, approximately 3 months
Utilization of intervention content
Time frame: Baseline to 3 months post-treatment, approximately 6 months
Results and safety
The study was stopped early (reason given: No funds remained for additional recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. There is no current plan to share IPD with other researchers.
Related trials for Suicide, Attempted
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
Active, not recruiting
Motivational Interviewing to Address Suicidal Ideation for Veterans at High Risk for Suicide
Suicide, Attempted, Suicidal Ideation
Recruiting
Suicide Preventive Psychosocial Treatment for Youths
Suicide Attempt, Suicidal and Self-injurious Behavior
Recruiting
Evaluation of a Multi-Layered Digital Phenotyping, Digital Safety Plan, and Pharmacogenomic Intervention for Suicide Prevention in Adults With Depression
Depressive Disorder, Major Depressive Disorder, Suicidal Ideation
Not yet recruiting
THRIVE: A Recovery-Focused Suicide Prevention Intervention in Crisis Stabilization Centers
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.
Ian Cero, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acute Youth Connect in people with Suicide, Attempted, run by University of Rochester 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?
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: stopped early, as of the sponsor's last update on 16 Apr 2024. 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 was stopped early (reason given: No funds remained for additional recruitment). Results are not available in the source record.
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?
Number of youth who complete the intervention (time frame: Interactive sessions by the end of the 12-week intervention.). 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?
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 16 Apr 2024.