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Network Health Intervention for Adolescents Leaving Acute Psychiatric Care

Primary Purpose

Suicide, Attempted

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acute Youth Connect
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide, Attempted focused on measuring suicide, suicide attempt, suicide ideation, adolescent, social network

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Rochester Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute Youth Connect + TAU

Arm Description

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

Outcomes

Primary Outcome Measures

Number of youth who complete the intervention
Youth subjects who complete all three interactive sessions will be marked as "treatment completers."
Text message responses
Text message prompts will be marked as "responded to" when a recipient produces at least one reply.
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".

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
March 3, 2022
Last Updated
July 13, 2023
Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT05340296
Brief Title
Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
Official Title
Network Health Intervention for Adolescents Leaving Acute Psychiatric Care
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2022 (Actual)
Primary Completion Date
July 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
Collaborators
National Institutes of Health (NIH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted
Keywords
suicide, suicide attempt, suicide ideation, adolescent, social network

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
All subjects will receive Acute Youth Connect plus treatment as usual.
Masking
None (Open Label)
Masking Description
There is only one arm. No masking will be attempted.
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute Youth Connect + TAU
Arm Type
Experimental
Arm Description
Subjects will receive 12 weeks of post-discharge Acute Youth Connect intervention, in addition to regular post-discharge treatment as usual.
Intervention Type
Behavioral
Intervention Name(s)
Acute Youth Connect
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of youth who complete the intervention
Description
Youth subjects who complete all three interactive sessions will be marked as "treatment completers."
Time Frame
Interactive sessions by the end of the 12-week intervention.
Title
Text message responses
Description
Text message prompts will be marked as "responded to" when a recipient produces at least one reply.
Time Frame
A text message must be responded to before the next text message prompt is sent (roughly one week).
Title
Adult support team treatment completion
Description
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".
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.
Secondary Outcome Measure Information:
Title
Change in weekly contact to supportive adults in their lives
Description
Youth subjects will report a change in the average weekly contact with the members of their adult support team, compared to reported baseline contact.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Change in weekly contact to supportive adults in their lives
Description
Youth subjects will report a change in the average weekly contact with the members of their adult support team, compared to reported baseline contact.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Utilization of intervention content
Description
Rate of adolescents reporting using at least two of the three Acute Youth Connect cores (connection, balance, purpose) weekly or more.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Utilization of intervention content
Description
Rate of adolescents reporting using at least two of the three Acute Youth Connect cores (connection, balance, purpose) weekly or more.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Other Pre-specified Outcome Measures:
Title
Change in perceived social connectedness
Description
Interpersonal Needs Questionnaire - Belongingness subscale. Total scores range from 0-54, higher scores indicate more social distress. We predict a change in distress.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Change in perceived social connectedness
Description
Interpersonal Needs Questionnaire - Belongingness subscale. Total scores range from 0-54, higher scores indicate more social distress. We predict a change in distress.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Change in feelings of meaning
Description
Claremont Purpose Scale - Personal Meaning subscale. Total scores range from 0-16 for each subscale scale. Higher scores indicate more feelings of meaning and purpose. We predict a change in scores on each subscale.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Change in feelings of meaning
Description
Claremont Purpose Scale - Personal Meaning subscale. Total scores range from 0-16 for each subscale scale. Higher scores indicate more feelings of meaning and purpose. We predict a change in scores on each subscale.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Change in feelings of purpose
Description
Claremont Purpose Scale - Goal-directedness subscale. Total scores range from 0-16 for each subscale scale. Higher scores indicate more feelings of meaning and purpose. We predict a change in scores on each subscale.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Change in feelings of purpose
Description
Claremont Purpose Scale - Goal-directedness subscale. Total scores range from 0-16 for each subscale scale. Higher scores indicate more feelings of meaning and purpose. We predict a change in scores on each subscale.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Changes in interpersonal emotion regulation
Description
Interpersonal Emotion Regulation Questionnaire - Social Modeling Subscale (scores range from 5-25, higher scores indicate improved functioning). We predict a change in scores.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Changes in interpersonal emotion regulation
Description
Interpersonal Emotion Regulation Questionnaire - Social Modeling Subscale (scores range from 5-25, higher scores indicate improved functioning). We predict a change in scores.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Changes in access to emotion regulation strategies
Description
Difficulties in Emotion Regulation Scale - Regulation Strategies Subscale (scores range from 3-15, higher scores indicate greater dysfunction). We predict a change in scores.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Changes in access to emotion regulation strategies
Description
Difficulties in Emotion Regulation Scale - Regulation Strategies Subscale (scores range from 3-15, higher scores indicate greater dysfunction). We predict a change in scores.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months
Title
Changes in engagement with healthy activities
Description
Behavioral Activation for Depression - Short form - Activation Subscale. Scores range from 5-35, with higher scores indicating greater function. We predict a change in function.
Time Frame
Baseline to post-treatment, approximately 3 months
Title
Changes in engagement with healthy activities
Description
Behavioral Activation for Depression - Short form - Activation Subscale. Scores range from 5-35, with higher scores indicating greater function. We predict a change in function.
Time Frame
Baseline to 3 months post-treatment, approximately 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ian Cero, PhD
Phone
(585) 275-2100
Email
ian_cero@urmc.rochester.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Peter Wyman, PhD
Phone
(585) 276-3000
Email
peter_wyman@urmc.rochester.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ian Cero, PhD
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ian Cero, PhD
Phone
585-275-2100
Email
ian_cero@urmc.rochester.edu
First Name & Middle Initial & Last Name & Degree
Ian Cero, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no current plan to share IPD with other researchers.

Learn more about this trial

Network Health Intervention for Adolescents Leaving Acute Psychiatric Care

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