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ACE Screening Implementation for Adverse Childhood Experiences

N/A

Recruiting

Led By Monica Perez Jolles, PhD

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7.5 months

Awards & highlights

Study Summary

This trial will test a strategy to support the implementation of a policy for universal ACE screening in community clinics, with the goal of improving child-level outcomes.

Who is the study for?

This trial is for caregivers of children aged 0-5 who are scheduled for a wellness visit. The caregiver must be over 18, have legal custody or authority, and agree to complete screenings and share de-identified data. It's not for those unwilling to consent or outside the age range of 0-5.Check my eligibility

What is being tested?

The study tests a strategy to implement universal screening for Adverse Childhood Experiences (ACEs) in clinics, following California's policy. It aims to see if this approach helps detect ACEs during well-child visits and improves child-level outcomes.See study design

What are the potential side effects?

Since this trial involves implementation strategies rather than medical treatments, there are no direct side effects like you would expect with medication. However, participating may involve time commitment and emotional impact from discussing ACEs.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7.5 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7.5 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7.5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Acceptability of the intervention and strategy

Feasibility of the intervention and strategy

Fidelity of the screening process

+1 more

Secondary outcome measures

Changes in Baby Pediatric Symptoms (BPSS) / Preschool PSC (PPSC)

Mental health service referrals

Side effects data

From 2016 Phase 3 trial • 300 Patients • NCT02008565

51%

Constipation

Urinary tract infection

Diarrhoea

Headache

Fall

Abdominal distension

Abdominal pain

Upper respiratory tract infection

Nausea

Haemorrhoids

Breast cancer

Hip fracture

Syncope

Medical device removal

Back pain

Animal bite

Suture related complication

100%

80%

60%

40%

20%

Study treatment Arm

Placebo - Education Only

Loperamide - Exercise Plus Biofeedback

Loperamide - Education Only

Placebo - Exercise Plus Biofeedback

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: ACEs ScreeningExperimental Treatment1 Intervention

Adverse Childhood Experiences (ACEs) are potentially traumatic events occurring before age 18, such as maltreatment, harsh migration experiences or exposure to violence. ACEs screening are increasingly recommended to prevent and address physical and mental health conditions associated with ACEs. To promote ACEs screening uptake, the state of California issued the "ACEs Aware" 2020 policy; a fee-for-service health policy that provides a financial incentive to Medicaid-serving clinics to promote yearly ACEs pediatric screenings in primary care settings. This study will focus on screening children ages 0-5, in line with the partnering FQHC's ACEs screening priorities.

Group II: Multifaceted Implementation StrategyActive Control1 Intervention

The core implementation strategy components are: 1) short video-trainings for clinic personnel (care team staff and providers) on the administration of caregiver-reported screening tools; 2) technical implementation support using an approach comprised of external academic consultants, and internal FQHC personnel to increase inner context capacity, 3) use of a validated clinical screening tool - Pediatric Symptoms Checklist (PSC-17), used in pediatric primary care settings to assess behavioral and social/emotional development. For this study, we will use the PSC tools that are tailored to children ages 0 to 5 years old with the Baby Pediatric Symptomatology Checklist (BPSC) for ages 0 to 18 months, and the Preschool Pediatric Symptom Checklist (PPSC) for ages 18 to 60 months. This screening tools is needed as the PEARLS only assesses ACEs exposure and not mental health symptomatology; and 4) use of a technology based tailored ACEs algorithm that incorporates multiple data sources.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Mental Health (NIMH)NIH

2,786 Previous Clinical Trials

2,688,425 Total Patients Enrolled

1 Trials studying Adverse Childhood Experiences

90 Patients Enrolled for Adverse Childhood Experiences

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,148,184 Total Patients Enrolled

University of Southern CaliforniaLead Sponsor

906 Previous Clinical Trials

1,594,946 Total Patients Enrolled

Media Library

Implementation Strategy of ACEs Screenings Clinical Trial Eligibility Overview. Trial Name: NCT04916587 — N/A

Adverse Childhood Experiences Research Study Groups: Multifaceted Implementation Strategy, ACEs Screening

Adverse Childhood Experiences Clinical Trial 2023: Implementation Strategy of ACEs Screenings Highlights & Side Effects. Trial Name: NCT04916587 — N/A

Implementation Strategy of ACEs Screenings 2023 Treatment Timeline for Medical Study. Trial Name: NCT04916587 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there opportunities for participants to join the trial at this time?

"Affirmative. Clinicaltrials.gov holds evidence that this study, initially posted on February 18th 2022, is actively recruiting participants from 1 site for a total of 1342 individuals."

Answered by AI

How many individuals are being enrolled in this research experiment?

"Affirmative. Data from clinicaltrials.gov reveals that this study is enrolling participants at this time, beginning on February 18th 2022 and most recently updated on May 19th 2022. The experiment seeks to include 1342 patients in total across 1 location."

Answered by AI

Is it possible for me to become involved in this clinical exploration?

"This clinical trial seeks to enrol 1342 pre-school aged children who have endured adverse childhood experiences. The age range for participants is between 0 and 5 years old."

Answered by AI