Clinical trial NCT06456762: Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
Official title: Developing and Testing a Text-messaging Intervention to Support Parents After Their Child's Psychiatric Emergency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parents
Self Efficacy
Mental Health Literacy
Psychiatric Emergency
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2024-06-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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 child's 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 (N=15) 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 (N=90), with n=30 parents randomized to enhanced usual care, n=30 randomized to enhanced usual care with text-message reminders, and n=30 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.

Eligibility criteria: Inclusion Criteria:

* Parents or legal guardians of a child ages 11-17;
* Parents or legal guardians must live with their child ≥50% of the time;
* Child must be admitted to the pediatric emergency department for a mental health crisis;
* Child must be discharged home from the emergency department with referrals to outpatient care.

Exclusion Criteria:

* Do not have daily access to a mobile phone that can receive SMS text messages;
* Do not speak and read fluently in English.

Primary outcomes:
measure: Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization
timeFrame: 24 weeks
measure: Child and Adolescent Services Assessment: Emergency Department Services Use
timeFrame: 24 weeks
Secondary outcomes:
measure: Suicidal Ideation Questionnaire - Jr.
timeFrame: 24 weeks
measure: Self-Injurious Thoughts and Behaviors Interview - Revised
timeFrame: 24 weeks.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Margaret Benningfield, MD
role: PRINCIPAL_INVESTIGATOR
References: