Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06456762
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-13
First Post:
2024-06-07
Brief Title:
Text-messaging Intervention to Support Parents After Their Childs Psychiatric Emergency
Sponsor:
Vanderbilt University Medical Center
Organization:
Vanderbilt University Medical Center
Study Overview
Official Title:
Developing and Testing a Text-messaging Intervention to Support Parents After Their Childs Psychiatric Emergency
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
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:
iPEACE
Brief Summary:
This grant aims to develop and test a text-messaging intervention for parents of children and teens evaluated in the emergency department for a psychiatric emergency and discharged home with outpatient referrals The intervention for parents will teach parents skills to navigate the mental health services system and build their self-efficacy in managing their childs mental health This research has the potential to improve services for families seeking emergency psychiatric support with the goal of facilitating treatment engagement and reducing emergency services utilization using scalable cost-effective accessible tools
Detailed Description:
Rates of emergency department ED visits for psychiatric emergencies in adolescents have increased substantially in the past decade including for suicidality self-harm and aggression A substantial number of these adolescents will be discharged home from the ED with referrals to outpatient mental health treatment Yet engagement in outpatient mental health treatment among adolescents is low and rates of repeated emergency services utilization are high highlighting the need for better supports for these youth and families While effective brief interventions have been developed to directly support adolescents at the time of their ED visit no evidence-based interventions have been developed to support parents of these youth Further the period following an emergency visit is known to be high risk yet no existing services support parents during the transition home while waiting for connection to outpatient services In this intervention development study the investigators seek to iteratively develop refine and test an automated text-messaging intervention for parents of youth discharged from the ED after a psychiatric emergency The 8-week intervention iPEACE intervention for parent education after care in the ED will directly target 1 parent mental health literacy and 2 parent self-efficacy with the goal of reducing ED utilization and enhancing outpatient mental health service use and engagement In the first phase of the study the investigators aim to develop and refine the intervention with stakeholder feedback Parents N15 will receive the 8-week iPEACE starting immediately following ED discharge Parents will provide both in-the-moment feedback via text-message surveys and in-depth feedback at the end of the 8-week period via semi-structured qualitative interviews and self-report measures The investigators will also conduct qualitative interviews with enrolled parents children and key ED stakeholders The investigators will use this feedback to refine the intervention materials In the second phase of the study the investigators will conduct a pilot randomized controlled trial N90 with n30 parents randomized to enhanced usual care n30 randomized to enhanced usual care with text-message reminders and n30 randomized to receive iPEACE Parents and their child evaluated in the ED will complete follow-up assessments at 4- 8- and 24-weeks to assess key intervention targets self-efficacy and mental health literacy and youth outcomes outpatient mental health service utilization ED utilization clinical symptom severity The goals for the proposed project include 1 developing and refining the iPEACE text-messaging intervention and 2 piloting the iPEACE intervention compared to enhanced usual care only and enhanced usual care with text-message reminders to assess key study outcomes and mechanisms to inform a fully-power randomized trial This R34 has important clinical implications as findings from this study may support the testing and implementation of a digital health intervention to improve outcomes for high-risk youth and families The proposed study has the potential to inform the provision of clinical services to support families during high-risk clinical transitions
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R34MH132711-01A1 | NIH | None | httpsreporternihgovquickSearchR34MH132711-01A1 |