NCT06456762

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress73%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

June 7, 2024

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 13, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

November 10, 2025

Status Verified

November 1, 2025

Enrollment Period

2.4 years

First QC Date

June 7, 2024

Last Update Submit

November 5, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Child and Adolescent Services Assessment: Outpatient Mental Health Service Utilization

    The Child and Adolescent Services Assessment will be used as a parent self-report measure that evaluates the total number of outpatient mental health appointments the participant's child attends during the follow-up period. The outcome will be a total count of the number of outpatient mental health appointments attended.

    24 weeks

  • Child and Adolescent Services Assessment: Emergency Department Services Use

    The Child and Adolescent Services Assessment will be used as a parent self-report measure to evaluate the number of psychiatric emergency department visits the participant's child has during the follow-up period. The outcome variable will be a dichotomous variable based on whether the child was readmitted to the emergency department during the follow-up period (yes/no).

    24 weeks

Secondary Outcomes (2)

  • Suicidal Ideation Questionnaire - Jr.

    24 weeks

  • Self-Injurious Thoughts and Behaviors Interview - Revised

    24 weeks.

Study Arms (3)

iPEACE: Intervention for Parent Education About Care after the ED

ACTIVE COMPARATOR

Parents in the iPEACE condition will receive an 8-week text-messaging intervention to build skills in mental health literacy and self-efficacy. Texts will be delivered several days per week over an 8-week period. The intervention is fully automated.

Behavioral: iPEACE: Intervention for Parent Education about Care after the ED

Text Reminders Only

ACTIVE COMPARATOR

Parents in the text-reminders only condition will receive weekly reminders to make an outpatient therapy appointment for their child. Texts will be fully automated, and will be delivered once a week for 8-weeks.

Behavioral: Text Messaging Reminders Only

Treatment as Usual

NO INTERVENTION

Parents in the TAU condition will receive typical treatment in the emergency department, including outpatient referrals and safety planning if needed prior to discharge.

Interventions

Automated texting intervention for parents to increase engagement in their child's outpatient mental health treatment over an 8-week period.

iPEACE: Intervention for Parent Education About Care after the ED

Weekly automated text reminders to instruct parents to make an appointment with their child's outpatient mental health provider over an 8-week period.

Text Reminders Only

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

Study Officials

  • Margaret Benningfield, MD

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margaret Benningfield, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry and Behavioral Sciences

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 13, 2024

Study Start

August 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

November 10, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

We will share data in accordance with the National Institutes of Health data sharing policy. Researchers can use the standard request process through the NIMH Data Archive to request access to the research data. The NIMH Data Archive Data Access Committee makes decisions about granting research access, which is allowable for one year with an option to renew.Data provided to the NDA will be de-identified and all participants will consent to data sharing at the time of study enrollment. The NIMH Data Archive GUID allows researchers to aggregate data from a single research participant such that they remain deidentified.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
We will submit individual participant data to the NIMH NDA every 6-months for the duration of the study. Uploads of all scientific and meta-data will be harmonized, validated, and submitted at 6-month intervals over the course of the award, following standard January 15 and July 15th deadlines.

Locations