Clinical trial NCT05340296: Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
Official title: Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Suicide, Attempted
Keywords: suicide
suicide attempt
suicide ideation
adolescent
social network
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2022-04-22
Enrollment: 19
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All subjects will receive Acute Youth Connect plus treatment as usual.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of youth who complete the intervention
timeFrame: Interactive sessions by the end of the 12-week intervention.
measure: Text message responses
timeFrame: A text message must be responded to before the next text message prompt is sent (roughly one week).
measure: Adult support team treatment completion
timeFrame: 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:
measure: Change in weekly contact to supportive adults in their lives
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Change in weekly contact to supportive adults in their lives
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Utilization of intervention content
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Utilization of intervention content
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
Other outcomes:
measure: Change in perceived social connectedness
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Change in perceived social connectedness
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Change in feelings of meaning
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Change in feelings of meaning
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Change in feelings of purpose
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Change in feelings of purpose
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Changes in interpersonal emotion regulation
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Changes in interpersonal emotion regulation
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Changes in access to emotion regulation strategies
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Changes in access to emotion regulation strategies
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
measure: Changes in engagement with healthy activities
timeFrame: Baseline to post-treatment, approximately 3 months
measure: Changes in engagement with healthy activities
timeFrame: Baseline to 3 months post-treatment, approximately 6 months
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Ian Cero, PhD
role: PRINCIPAL_INVESTIGATOR
References: