Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460220
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-07-03
First Post:
2024-06-11
Brief Title:
SAFETY-Parent Online Learning Module to Support Parents of Suicidal Youth
Sponsor:
Jennifer Hughes
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
SAFETY-Parent Online Learning Module to Support Parents of Suicidal Youth
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SAFETY-P
Brief Summary:
This project aims to adapt the parent component of Safe Alternatives for Teens and Youth SAFETY outpatient intervention to SAFETY-Parent SAFETY-P a self-paced interactive learning module for parents to be implemented as an augmentation for youth being seen for suicidal ideation suicidal behavior or recent suicide attempts across multiple settings at Nationwide Childrens Hospital NCH Columbus Ohio
Detailed Description:
This research project has iterative aims focused on the development and pilot testing of the SAFETY-P asynchronous parent intervention module Phase 1 will focus on finalizing SAFETY-P content for the online learning module Phase 2 will be a small open case series integrating additional key stakeholder feedback via formative usability testing Phase 3 will test the revised module in a pilot RCT to establish methods and protocols for a future large-scale clinical trial
Phase 1Aim 1 Intervention Adaptation for Online Delivery Phase 1 will include 4 separate stakeholder focus groups adolescents parents behavioral health BH inpatient and outpatient providers and parent survivors of suicide loss to advise on adaptations to SAFETY-P and development of the self-paced interactive module to be used in Phase 2
Aim 1 Adapt the parent component of SAFETY to content for the SAFETY-P asynchronous parent intervention module and determine feasibility and acceptability of SAFETY-P to this asynchronous module delivery
Hypothesis Hyp 11 SAFETY content will be adapted successfully to SAFETY-P stakeholders will report that use of an online asynchronous learning module for parents is feasible and acceptable based on qualitative coding outcomes
Phase 2Aim 1 Case Series Iterative Adaptation Phase 2 will include pilot testing of SAFETY-P with a nonrandomized case series of 5 clinicians and 10 families Participants will be invited to use SAFETY-P for up to one month Feedback from this case series will inform iterative adaptations to the SAFETY-P module
Hyp 12 SAFETY-P will be feasible to use parents will report using SAFETY-P at least twice during the one month clinicians will report discussing SAFETY-P content with parents at least once during the one month
Hyp 13 Parents and clinicians will report that use of SAFETY-P is acceptable via formative usability testing interview feedback and on measures of acceptability System Usability Questionnaire rating of 68 Mobile Application Rating Scale User Version uMARS acceptable scores 3
Phase 3Aims 2-4 Pilot RCT of SAFETY-P To assess feasibility and acceptability of SAFETY-P we will conduct a pilot RCT with N30 youth and parents who will be randomized to either SAFETY-P treatment as usual TAU or to TAU alone
Aim 2 Conduct a pilot study of SAFETY-P Outcomes will include study recruitment and retention rates SAFETY-P parent satisfaction ratings clinician-report of SAFETY-P use and effectiveness and adverse event reports
Hyp 21 The sample can be recruited in 1 year Hyp 22 80 will participate throughout the 3 months Hyp 23 Parents will report using SAFETY-P 2 times Hyp 24 Parents will report high satisfaction on the SAFETY-P Satisfaction Scale acceptable item scores 3 and the Peabody Treatment Progress Battery Service Satisfaction Scale acceptable item scores 3
Hyp 25 Clinicians will report high satisfaction on the SAFETY-P Satisfaction Scale acceptable item scores 3
Exploratory Aim 3 Parent Outcomes Investigate if SAFETY-P leads to changes parent functioning the intervention target - at 1 and 3-month follow-up we will measure between-group differences
Hyp 31 SAFETY-PTAU parents will have preferential outcomes on a parent emotion regulation b parent depressive symptoms c caregiver strain d family conflict e parent perceived self-efficacy to manage their childs suicidal crises and f parent expectations of adolescents risk
Exploratory Aim 4 Youth Outcomes Explore preliminary effectiveness of the SAFETY-P at decreasing youth suicide risk factors - we will measure between-group differences at 1 and 3-month follow-up
Hyp 41 SAFETY-PTAU youth will have preferential outcomes on a youth suicidal ideation SI b suicide attempts SA c non-suicidal self-injury NSSI d and services use including TAU sessions attended and use of higher levels of care for suicidal crises such as emergency department or inpatient hospitalization e family conflict f thwarted belongingness and g perceived burdensomeness
Phase 1Aim 1 Intervention Adaptation for Online Delivery Phase 1 will include 4 separate stakeholder focus groups adolescents parents behavioral health BH inpatient and outpatient providers and parent survivors of suicide loss to advise on adaptations to SAFETY-P and development of the self-paced interactive module to be used in Phase 2
Aim 1 Adapt the parent component of SAFETY to content for the SAFETY-P asynchronous parent intervention module and determine feasibility and acceptability of SAFETY-P to this asynchronous module delivery
Hypothesis Hyp 11 SAFETY content will be adapted successfully to SAFETY-P stakeholders will report that use of an online asynchronous learning module for parents is feasible and acceptable based on qualitative coding outcomes
Phase 2Aim 1 Case Series Iterative Adaptation Phase 2 will include pilot testing of SAFETY-P with a nonrandomized case series of 5 clinicians and 10 families Participants will be invited to use SAFETY-P for up to one month Feedback from this case series will inform iterative adaptations to the SAFETY-P module
Hyp 12 SAFETY-P will be feasible to use parents will report using SAFETY-P at least twice during the one month clinicians will report discussing SAFETY-P content with parents at least once during the one month
Hyp 13 Parents and clinicians will report that use of SAFETY-P is acceptable via formative usability testing interview feedback and on measures of acceptability System Usability Questionnaire rating of 68 Mobile Application Rating Scale User Version uMARS acceptable scores 3
Phase 3Aims 2-4 Pilot RCT of SAFETY-P To assess feasibility and acceptability of SAFETY-P we will conduct a pilot RCT with N30 youth and parents who will be randomized to either SAFETY-P treatment as usual TAU or to TAU alone
Aim 2 Conduct a pilot study of SAFETY-P Outcomes will include study recruitment and retention rates SAFETY-P parent satisfaction ratings clinician-report of SAFETY-P use and effectiveness and adverse event reports
Hyp 21 The sample can be recruited in 1 year Hyp 22 80 will participate throughout the 3 months Hyp 23 Parents will report using SAFETY-P 2 times Hyp 24 Parents will report high satisfaction on the SAFETY-P Satisfaction Scale acceptable item scores 3 and the Peabody Treatment Progress Battery Service Satisfaction Scale acceptable item scores 3
Hyp 25 Clinicians will report high satisfaction on the SAFETY-P Satisfaction Scale acceptable item scores 3
Exploratory Aim 3 Parent Outcomes Investigate if SAFETY-P leads to changes parent functioning the intervention target - at 1 and 3-month follow-up we will measure between-group differences
Hyp 31 SAFETY-PTAU parents will have preferential outcomes on a parent emotion regulation b parent depressive symptoms c caregiver strain d family conflict e parent perceived self-efficacy to manage their childs suicidal crises and f parent expectations of adolescents risk
Exploratory Aim 4 Youth Outcomes Explore preliminary effectiveness of the SAFETY-P at decreasing youth suicide risk factors - we will measure between-group differences at 1 and 3-month follow-up
Hyp 41 SAFETY-PTAU youth will have preferential outcomes on a youth suicidal ideation SI b suicide attempts SA c non-suicidal self-injury NSSI d and services use including TAU sessions attended and use of higher levels of care for suicidal crises such as emergency department or inpatient hospitalization e family conflict f thwarted belongingness and g perceived burdensomeness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None