NCT05340296

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2022

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 3, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 22, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

July 1, 2022

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 6, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 6, 2023

Completed
Last Updated

April 16, 2024

Status Verified

April 1, 2024

Enrollment Period

1.3 years

First QC Date

March 3, 2022

Last Update Submit

April 12, 2024

Conditions

Keywords

suicidesuicide attemptsuicide ideationadolescentsocial network

Outcome Measures

Primary Outcomes (3)

  • Number of youth who complete the intervention

    Youth subjects who complete all three interactive sessions will be marked as "treatment completers."

    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.

    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".

    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

    Baseline to post-treatment, approximately 3 months

  • Change in weekly contact to supportive adults in their lives

    Baseline to 3 months post-treatment, approximately 6 months

  • Utilization of intervention content

    Baseline to post-treatment, approximately 3 months

  • Utilization of intervention content

    Baseline to 3 months post-treatment, approximately 6 months

Other Outcomes (12)

  • Change in perceived social connectedness

    Baseline to post-treatment, approximately 3 months

  • Change in perceived social connectedness

    Baseline to 3 months post-treatment, approximately 6 months

  • Change in feelings of meaning

    Baseline to post-treatment, approximately 3 months

  • +9 more other outcomes

Study Arms (1)

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.

Behavioral: Acute Youth Connect

Interventions

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.

Acute Youth Connect + TAU

Eligibility Criteria

Age12 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Suicide, AttemptedSuicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Study Officials

  • Ian Cero, PhD

    University of Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
There is only one arm. No masking will be attempted.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All subjects will receive Acute Youth Connect plus treatment as usual.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior Instructor

Study Record Dates

First Submitted

March 3, 2022

First Posted

April 22, 2022

Study Start

July 1, 2022

Primary Completion

October 6, 2023

Study Completion

October 6, 2023

Last Updated

April 16, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will not share

There is no current plan to share IPD with other researchers.

Locations