NCT06574633

Brief Summary

Adverse childhood experiences (ACEs) are traumatic exposures that can cause many negative health impacts across life. ACEs are common in patients who seek out care in pediatric emergency departments (PEDs); this is an opportunity to connect families with mental health resources to mitigate the effects of ACEs and improve lifelong health. The goal of this study is to determine if children with high ACEs have better rates of follow-up with mental health resources when a telehealth option is provided, as previous research has shown that simply making an in-person follow-up appointment is not very helpful.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

August 26, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 28, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

October 3, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
Last Updated

April 25, 2025

Status Verified

April 1, 2025

Enrollment Period

3 months

First QC Date

August 26, 2024

Last Update Submit

April 24, 2025

Conditions

Keywords

TeenagersAdolescentsPediatric Emergency Department (PED).Therapy Services

Outcome Measures

Primary Outcomes (1)

  • Rate of attendance between groups after Behavioral Mental Health Specialist (BMHS) referral.

    Researchers will ask the therapy offices and participants if they were able to make it to the therapy appointment that was scheduled.

    Within 24 weeks after scheduled appointment date

Secondary Outcomes (5)

  • Positive Childhood Experiences (PCEs) scores between groups

    Baseline and Within 24 weeks after scheduled appointment date

  • Child-reported and caregiver-reported Adverse Childhood Experiences (ACEs) and PCEs

    Baseline

  • ACEs prevalence by zip code between groups

    Baseline

  • Community Resources by zip code

    Baseline

  • Child opportunity index (COI)

    Baseline

Study Arms (2)

In-person therapy

ACTIVE COMPARATOR
Behavioral: In-person therapy

Telehealth

EXPERIMENTAL
Behavioral: Telehealth therapy

Interventions

Participants will be referred to in-person therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).

In-person therapy

Participants will be referred to telehealth therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).

Telehealth

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Patients aged 12-17 years seen in the PED who read and speak English

You may not qualify if:

  • Patients already enrolled in outpatient therapy resources,
  • Critically ill patients
  • Patients with significant developmental delays impeding their ability to participate in therapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Children's Healthcare of Atlanta at Hughes Spalding

Atlanta, Georgia, 30303, United States

Location

Children's Healthcare of Atlanta (CHOA)

Atlanta, Georgia, 30322, United States

Location

Children's Healthcare of Atlanta at Egleston

Atlanta, Georgia, 30322, United States

Location

Arthur M. Blank Hospital | Children's Healthcare of Atlanta

Atlanta, Georgia, 30329, United States

Location

MeSH Terms

Conditions

Oculocutaneous albinism type 2

Study Officials

  • Karli S. Okeson, DO

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 28, 2024

Study Start

October 3, 2024

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

April 25, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will share

The Research Team will share individual participants' data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices)

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
The research team will share deidentified data beginning 3 months and ending 2 years after publication.
Access Criteria
Proposals should be directed to karli.okeson@emory.edu. To gain access, data regulators will need to sign a data access agreement.

Locations