Adverse Childhood ExperiencesNCT06574633
ACEs Referral From PED
A study testing In-person therapy and Telehealth therapy in people with Adverse Childhood Experiences, run by Emory University at 4 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences
- What is being tested?
- In-person therapy and Telehealth therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 4 sitesUnited States
- Study dates
- 3 Oct 2024to 9 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Patients aged 12-17 years seen in the PED who read and speak English
Who cannot join
- Patients already enrolled in outpatient therapy resources,
- Critically ill patients
- Patients with significant developmental delays impeding their ability to participate in therapy.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Children's Healthcare of Atlanta at Hughes Spalding
Atlanta, Georgia, 30303
Children's Healthcare of Atlanta (CHOA)
Atlanta, Georgia, 30322
Children's Healthcare of Atlanta at Egleston
Atlanta, Georgia, 30322
Arthur M. Blank Hospital | Children's Healthcare of Atlanta
Atlanta, Georgia, 30329
About this study
Official title: Adverse Childhood Experiences (ACEs) Resource Referral Process in the Pediatric Emergency Department
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.
Read the detailed description
Children 12-17 years old who are receiving care in a PED and their legal guardians will fill out a tablet-based electronic consent/assent and survey that takes no longer than 10 minutes to complete while waiting for treatment once they are in a private patient room. The study team will review the responses to identify children with ACE scores 2 or higher and contact the family to help them arrange therapy services. Patients will be randomized to in-person versus telehealth therapy. A few months after enrollment, the study team will contact the family and mental health team to find out if the family was able to keep their appointment to start mental health treatment. This will aid future research to identify if and how mental health treatment impacts these patients over the following years.
- Conditions
- Adverse Childhood Experiences
- Being tested
- In-person therapy, Telehealth therapy
- Keywords
- Teenagers, Adolescents, Pediatric Emergency Department (PED)., Therapy Services
- Medical subject headings
- Oculocutaneous albinism type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-person therapyBehavioural
Participants will be referred to in-person therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).
Telehealth therapyBehavioural
Participants will be referred to telehealth therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS).
| Study group | Role | What they receive |
|---|---|---|
| In-person therapy | Active comparator | Not described Receives: Behavioral: In-person therapy |
| Telehealth | Experimental | Not described Receives: Behavioral: Telehealth therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 24 weeks after scheduled appointment date
Secondary outcomes (5)
Positive Childhood Experiences (PCEs) scores between groups
Research has determined 7 specific Positive Childhood Experiences, or PCEs, that could be linked to a higher likelihood of positive health outcomes and a reduction in the negative outcomes associated with ACEs or toxic stress. Thinking about your life / your child's life, do you agree with the following statements? (yes/no)
- I am able to talk with family about feelings.
- I have the sense that family is supportive during difficult times.
- I have the enjoyment of participation in community traditions.
- I have the feeling of a sense of belonging in school.
- I feel supported by friends.
- I have at least two non-parent adults who genuinely cared.
- I feel safe and protected by an adult in the home.
Individuals with high PCE scores have a higher ability to seek social and emotional support and better follow-up rates for therapy services
Measured: Baseline and Within 24 weeks after scheduled appointment date
Child-reported and caregiver-reported Adverse Childhood Experiences (ACEs) and PCEs
Adverse childhood experiences (ACEs) are traumatic events that happen between ages 1 and 17. Researchers will use the Pediatric ACEs and Related Life Events Screener (PEARLS). The PEARLS includes an ACE screen (Part 1) as well as a social determinants of health (SDOH) screen (Part 2). ACE screen-10 questions (yes/no) that screen for a history of abuse, neglect, and household dysfunction. The ACE score refers to the total number of ACE categories experienced, rather than the severity or frequency of any one category. The total score ranges between 0 and 10.
PEARLS adolescent tool, for ages 12-19, to be completed by a caregiver, and PEARLS for adolescent self-report tool, for ages 12-19, to be completed by the adolescent.
Comparison between child-reported ACEs and PCEs and caregiver-reported ACEs and PCEs of their child to determine if there is variability.
Measured: Baseline
ACEs prevalence by zip code between groups
Adverse childhood experiences, or ACEs, are potentially traumatic events that occur in childhood (0-17 years). Researchers will use the Pediatric ACEs and Related Life Events Screener (PEARLS). The PEARLS includes an ACE screen (yes/no). The ACE score refers to the total number of ACE categories experienced, rather than the severity or frequency of any one category. The total score ranges between 0 and 10. Investigators will analyze the total scores using the zip codes provided by participants.
Measured: Baseline
Community Resources by zip code
Community Resources by zip code between groups. Investigators will analyze the available community resources along with the ACE prevalence in the area using the zip codes provided by participants and compare between groups.
Measured: Baseline
Child opportunity index (COI)
The COI is a composite index of children's neighborhood opportunity that contains data for every neighborhood (census tract) in the United States from every year from 2012 through 2021. It is comprised of 44 indicators in three domains (education, health and environment, and social and economic) and 14 subdomains. . ACEs prevalence with Community Resources and Child Opportunity Index (COI) by zip code Community Resources by zip code between groups. The COI is a composite index of children's neighborhood opportunity that contains data for every neighborhood (census tract) in the United States from every year from 2012 through 2021. It is comprised of 44 indicators in three domains (education, health and environment, and social and economic) and 14 subdomains.
Investigators will analyze COI along with ACE prevalence in the area using the zip codes provided by participants and compare between groups.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2024
- Study start3 Oct 2024
- Primary completion9 Jan 2025
- Study completion9 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adverse Childhood ExperiencesStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karli S. Okeson, Emory University
- Investigators
- Karli S. Okeson, DO, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06574633
- Sponsor's protocol ID
- STUDY00008134
- Status last verified
- Apr 2025
- First submitted
- 26 Aug 2024
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Research Team will share individual participants' data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices)
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adverse Childhood Experiences (ACEs) Resource Referral Process in the Pediatric Emergency Department
- ClinicalTrials.gov ID
- NCT06574633
- Acronym / sponsor ID
- STUDY00008134
- Conditions
- Adverse Childhood Experiences
- Keywords
- Teenagers, Adolescents, Pediatric Emergency Department (PED)., Therapy Services
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 3 Oct 2024 (actual)
- Primary completion
- 9 Jan 2025 (actual)
- Study completion
- 9 Jan 2025 (actual)
- First posted
- 28 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Children 12-17 years old who are receiving care in a PED and their legal guardians will fill out a tablet-based electronic consent/assent and survey that takes no longer than 10 minutes to complete while waiting for treatment once they are in a private patient room. The study team will review the responses to identify children with ACE scores 2 or higher and contact the family to help them arrange therapy services. Patients will be randomized to in-person versus telehealth therapy. A few months after enrollment, the study team will contact the family and mental health team to find out if the family was able to keep their appointment to start mental health treatment. This will aid future research to identify if and how mental health treatment impacts these patients over the following years.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| In-person therapy | Active comparator | Behavioral: In-person therapy |
| Telehealth | Experimental | Behavioral: Telehealth therapy |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients aged 12-17 years seen in the PED who read and speak English
Key exclusion criteria (3 listed)
- Patients already enrolled in outpatient therapy resources,
- Critically ill patients
- Patients with significant developmental delays impeding their ability to participate in therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| In-person therapyParticipants will be referred to in-person therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS). | Behavioural | In-person therapy |
| Telehealth therapyParticipants will be referred to telehealth therapy services when facilitating referral resources by a dedicated behavioral mental health specialist (BMHS). | Behavioural | Telehealth |
Primary outcome
Rate of attendance between groups after Behavioral Mental Health Specialist (BMHS) referral.
Time frame: Within 24 weeks after scheduled appointment date
Researchers will ask the therapy offices and participants if they were able to make it to the therapy appointment that was scheduled.
5 secondary outcomes
Positive Childhood Experiences (PCEs) scores between groups
Time frame: Baseline and Within 24 weeks after scheduled appointment date
Child-reported and caregiver-reported Adverse Childhood Experiences (ACEs) and PCEs
Time frame: Baseline
ACEs prevalence by zip code between groups
Time frame: Baseline
Community Resources by zip code
Time frame: Baseline
Child opportunity index (COI)
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Individual participant dataSharing planned: Yes. The Research Team will share individual participants' data that underlie the results reported in the article, after deidentification (text, tables, figures, and appendices)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karli S. Okeson, DO principal investigator
Emory University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-person therapy and Telehealth therapy in people with Adverse Childhood Experiences, run by Emory University at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of attendance between groups after Behavioral Mental Health Specialist (BMHS) referral. (time frame: Within 24 weeks after scheduled appointment date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.