Ignite Creation Date:
2024-05-06 @ 11:18 AM
Last Modification Date:
2024-10-26 @ 12:43 PM
Study NCT ID:
NCT03487627
Status:
COMPLETED
Last Update Posted:
2022-12-30
First Post:
2018-03-16
Brief Title:
Integrated Intervention for Caregivers--Pilot RCT
Sponsor:
Wake Forest University Health Sciences
Organization:
Wake Forest University Health Sciences
Study Overview
Official Title:
Integrated Electronic and Care Manager Support Intervention For Caregivers of Adolescents With Suicidal Behavior--Pilot RCT
Status:
COMPLETED
Status Verified Date:
2022-12
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:
None
Brief Summary:
Adolescents who have been hospitalized for suicidal behavior are at risk for engaging in additional suicidal behavior After hospitalization parents or guardians are typically asked to be responsible for helping to prevent further suicidal behavior This can include monitoring the youth making sure the home is safe getting the youth any needed treatment and balancing the parents expectations of the youth with the understanding that the youth is in a vulnerable state Even with this effort by parents adolescents often have additional crisis situations The goal of this study is to develop and test an integrated electronic and care support service intervention for these caregivers of suicidal youth It is expected that this intervention will help parentsguardians in the roles of caring for suicidal youth after discharge from the hospital This pilot randomized controlled trial will compare the intervention to enhanced treatment as usual
Detailed Description:
Adolescents who have been hospitalized for suicidal behavior are at high risk for engaging in additional suicidal behavior Following hospitalization parents or guardians are typically tasked with helping to prevent further suicidal episodes by monitoring youth ensuring safety in the home helping youth receive needed care and parenting in a way that balances expectations for appropriate behavior with recognition of the vulnerable status of the adolescents Despite parental efforts adolescents often have additional crises which sometimes culminate in emergency department visits and repeat hospitalizations Findings from the principal investigators recent longitudinal study of mothers after adolescent hospitalization for suicide attempts Impact of Adolescent Hospitalization on Parents suggested that the period of time following discharge from the hospital can be a very important time for providing services and supports to youth and families Parents in that study described emotional distress eg depression anxiety and reduced parenting self-efficacy and indicated a need for more information about suicidal youth and the treatment needs of these youth parenting and monitoring of suicidal youth and support in navigating the treatment system
Given these needs the purpose of this study is to develop refine and preliminarily test an integrated electronic and care support service intervention for caregivers of adolescents who have recently engaged in suicidal behavior It is expected that such an intervention will provide needed information and supports to parents increase parenting self-efficacy increase parents ability to follow safety plans in the home reduce parents emotional distress and help parents access needed services in the community As a consequence of these proximal outcomes it is expected that the intervention will help facilitate treatment engagement and follow through for youth and caregiver and reduce use of emergency mental health services and hospitalizations
The primary aim is to obtain in a pilot randomized controlled trial preliminary estimates of treatment effectiveness relative to enhanced treatment as usual The proposed adaptive services intervention development research is intended to demonstrate the feasibility and potential utility of an intervention that will be embedded in the existing care system psychiatric inpatient unit for suicidal youth and the families of these youth and ultimately improve engagement in services and client outcomes in high-risk families
Given these needs the purpose of this study is to develop refine and preliminarily test an integrated electronic and care support service intervention for caregivers of adolescents who have recently engaged in suicidal behavior It is expected that such an intervention will provide needed information and supports to parents increase parenting self-efficacy increase parents ability to follow safety plans in the home reduce parents emotional distress and help parents access needed services in the community As a consequence of these proximal outcomes it is expected that the intervention will help facilitate treatment engagement and follow through for youth and caregiver and reduce use of emergency mental health services and hospitalizations
The primary aim is to obtain in a pilot randomized controlled trial preliminary estimates of treatment effectiveness relative to enhanced treatment as usual The proposed adaptive services intervention development research is intended to demonstrate the feasibility and potential utility of an intervention that will be embedded in the existing care system psychiatric inpatient unit for suicidal youth and the families of these youth and ultimately improve engagement in services and client outcomes in high-risk families
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