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| ID | Type | Description | Link |
|---|---|---|---|
| 2KL2TR001999-05 | U.S. NIH Grant/Contract | View source | |
| https://osf.io/8pd54/ | Other Identifier | Open Science Foundation |
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No funds remained for additional recruitment
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acute Youth Connect | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to post-treatment, approximately 3 months |
| Change in weekly contact to supportive adults in their lives |
| Measure | Description | Time Frame |
|---|---|---|
| Change in perceived social connectedness | Interpersonal Needs Questionnaire - Belongingness subscale. Total scores range from 0-54, higher scores indicate more social distress. We predict a change in distress. | Baseline to post-treatment, approximately 3 months |
| Change in perceived social connectedness |
Youth subjects will be included if:
Youth subjects will be excluded if:
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 support team subjects will be excluded if:
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| Name | Affiliation | Role |
|---|---|---|
| Ian Cero, PhD | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
There is no current plan to share IPD with other researchers.
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Dec 13, 2021 | Mar 2, 2022 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013406 | Suicide, Attempted |
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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All subjects will receive Acute Youth Connect plus treatment as usual.
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There is only one arm. No masking will be attempted.
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Youth subjects will report a change in the average weekly contact with the members of their adult support team, compared to reported baseline contact. |
| 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. | 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. | Baseline to 3 months post-treatment, approximately 6 months |
Interpersonal Needs Questionnaire - Belongingness subscale. Total scores range from 0-54, higher scores indicate more social distress. We predict a change in distress. |
| Baseline to 3 months post-treatment, approximately 6 months |
| Change in feelings of meaning | 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. | Baseline to post-treatment, approximately 3 months |
| Change in feelings of meaning | 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. | Baseline to 3 months post-treatment, approximately 6 months |
| Change in feelings of purpose | 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. | Baseline to post-treatment, approximately 3 months |
| Change in feelings of purpose | 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. | Baseline to 3 months post-treatment, approximately 6 months |
| Changes in interpersonal emotion regulation | Interpersonal Emotion Regulation Questionnaire - Social Modeling Subscale (scores range from 5-25, higher scores indicate improved functioning). We predict a change in scores. | Baseline to post-treatment, approximately 3 months |
| Changes in interpersonal emotion regulation | Interpersonal Emotion Regulation Questionnaire - Social Modeling Subscale (scores range from 5-25, higher scores indicate improved functioning). We predict a change in scores. | Baseline to 3 months post-treatment, approximately 6 months |
| Changes in access to emotion regulation strategies | Difficulties in Emotion Regulation Scale - Regulation Strategies Subscale (scores range from 3-15, higher scores indicate greater dysfunction). We predict a change in scores. | Baseline to post-treatment, approximately 3 months |
| Changes in access to emotion regulation strategies | Difficulties in Emotion Regulation Scale - Regulation Strategies Subscale (scores range from 3-15, higher scores indicate greater dysfunction). We predict a change in scores. | Baseline to 3 months post-treatment, approximately 6 months |
| Changes in engagement with healthy activities | 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. | Baseline to post-treatment, approximately 3 months |
| Changes in engagement with healthy activities | 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. | Baseline to 3 months post-treatment, approximately 6 months |