Network Health Intervention for Adolescents Leaving Acute Psychiatric Care

NCT ID: NCT05340296

Last Updated: 2024-04-16

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-01
• Study Completion Date: 2023-10-06

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.

Conditions

Suicide, Attempted

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Acute Youth Connect + TAU

Subjects will receive 12 weeks of post-discharge Acute Youth Connect intervention, in addition to regular post-discharge treatment as usual.

Group Type: EXPERIMENTAL

Acute Youth Connect

Intervention Type: BEHAVIORAL

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.

Interventions

Acute Youth Connect

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Exclusion Criteria

• 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Ian Cero

Senior Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ian Cero, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2KL2TR001999-05

Identifier Type: NIH

Identifier Source: secondary_id

View Link

https://osf.io/8pd54/

Identifier Type: OTHER

Identifier Source: secondary_id

STUDY00006651

Identifier Type: -

Identifier Source: org_study_id