Adverse Childhood ExperiencesNCT05388864
Building Resilient Families
A study testing Three-Tier Model in people with Adverse Childhood Experiences, run by Loma Linda University at 1 site in United States.
Trial summary
Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. Read more about this study
- Who is it for?
- Ages 3 to 11 yearsHealthy volunteers can take part
- Conditions the study is for
- Adverse Childhood Experiences
- What is being tested?
- Three-Tier Model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2022to May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 3 to 11 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Ages 3-11
- Seen for a well-child visit at a participating pediatric clinic
Who cannot join
- < 3 years or >11 years of age
- Significant congenital medical problems
- Previous participation in parenting program (last 12 months)
- Sibling enrollment in current study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Loma Linda University
Loma Linda, California, 92354
Ariane Marie-Mitchell, MD, PhD, MPH
Ariane Marie-Mitchell, MD, PhD, MPH
About this study
Official title: A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)
Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.
To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.
- Conditions
- Adverse Childhood Experiences
- Being tested
- Three-Tier Model
- Keywords
- adverse childhood experiences, pediatrics, prevention, preventive health services, quality improvement, childhood abuse and neglect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Tier ModelBehavioural
Families in the intervention will be counseled by a pediatric provider about ACEs, resilience, stress management, and healthy relationships. Families will also be referred to community health workers and parenting educators.
| Study group | Role | What they receive |
|---|---|---|
| Three-Tier Model | Experimental | 130 children with ACEs who received well-child care by a trained provider will be enrolled in this group. Receives: Behavioral: Three-Tier Model |
| Comparison Group | No intervention | 80 children without ACEs who received usual well-child care will be enrolled in this group. |
| Control Group | No intervention | 130 children with ACEs who received usual well-child care will be enrolled in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Child Allostatic Load Index
A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up.
Measured: Change between baseline and visit 4 (1-year post-enrollment)
Secondary outcomes (1)
Pediatric Symptom Checklist (PSC)
The Pediatric Symptom Checklist is a psychosocial screen designed to indicate psychological impairment.
For participants ages 3-5, a total score of 24 indicates psychological impairment.
For participants ages 6-11, a total score of 28 indicates psychological impairment.
Measured: Change between baseline and visit 4 (1-year post-enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start24 May 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
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.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pediatric providers are randomized to training on the intervention or usual well-child care. Three groups of patients are recruited to evaluate the efficacy of the intervention: 1) Usual well-child care for children with no ACEs; 2) Usual well-child care for children with ACEs; and 3) Well-child care by providers trained in the intervention.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ariane Marie-Mitchell, MD, PhD, MPH, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05388864
- Sponsor's protocol ID
- 5180358
- Status last verified
- Jun 2026
- First submitted
- 19 May 2022
- Last updated
- 9 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Component Intervention to Strengthen Families With Adverse Childhood Experiences (ACEs)
- ClinicalTrials.gov ID
- NCT05388864
- Acronym / sponsor ID
- 5180358
- Conditions
- Adverse Childhood Experiences
- Keywords
- adverse childhood experiences, pediatrics, prevention, preventive health services, quality improvement, childhood abuse and neglect
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- 24 May 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 24 May 2022 (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.
Prior research suggests that it is possible to improve health outcomes in children with ACEs through multi-component interventions. The challenge for most communities is that health and education systems are fragmented and fail to accommodate families based upon different levels of need. This study utilizes cross-sectoral partnerships to mobilize three vectors (pediatricians, community health workers and parenting educators) to optimize the delivery of vital information and resources to a diverse population of families with ACEs. All vectors are trained in an evidence-informed curriculum to strengthen families and build youth resilience. The study design is a randomized controlled trial of 340 families of children between the ages of 3 to 11 who are generally healthy and have recently seen a pediatrician for a well-child visit.
To evaluate the efficacy of this intervention, pediatric patients are invited to participate in repeat evaluations within 2 weeks, 3 months, 6 months, and 12 months after their well-child visit. The study will evaluate the following: 1) the association between Child-ACE scores and biomarkers of toxic stress at baseline in children age 3-11 years old; 2) whether the intervention reduces toxic stress and child health and psychosocial problems at follow-up for children with ACEs compared to usual well-child care for children with ACEs; and 3) the impact of mediating and moderating variables. These results will demonstrate that for families with ACEs the intervention will decrease toxic stress associated with ACEs, improve health outcomes, and reduce health disparities.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Pediatric providers are randomized to training on the intervention or usual well-child care. Three groups of patients are recruited to evaluate the efficacy of the intervention: 1) Usual well-child care for children with no ACEs; 2) Usual well-child care for children with ACEs; and 3) Well-child care by providers trained in the intervention.
| Arm | Type | Receives |
|---|---|---|
| Three-Tier Model | Experimental | Behavioral: Three-Tier Model130 children with ACEs who received well-child care by a trained provider will be enrolled in this group. |
| Comparison Group | No intervention | –80 children without ACEs who received usual well-child care will be enrolled in this group. |
| Control Group | No intervention | –130 children with ACEs who received usual well-child care will be enrolled in this group. |
Who may qualify
- Ages
- 3 to 11 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Ages 3-11
- Seen for a well-child visit at a participating pediatric clinic
Key exclusion criteria (4 listed)
- < 3 years or >11 years of age
- Significant congenital medical problems
- Previous participation in parenting program (last 12 months)
- Sibling enrollment in current study
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 |
|---|---|---|
| Three-Tier ModelFamilies in the intervention will be counseled by a pediatric provider about ACEs, resilience, stress management, and healthy relationships. Families will also be referred to community health workers and parenting educators. | Behavioural | Three-Tier Model |
Primary outcome
Child Allostatic Load Index
Time frame: Change between baseline and visit 4 (1-year post-enrollment)
A composite measurement that combines biometric data, neuroendocrine and immune markers, and executive function to determine whether the intervention lowers physiologic stress for children with ACEs. Each group will be followed over one year and growth curves will be analyzed to compare change in physiologic stress between baseline and final follow-up.
1 secondary outcome
Pediatric Symptom Checklist (PSC)
Time frame: Change between baseline and visit 4 (1-year post-enrollment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jun 2026.
- Individual participant dataSharing planned: No
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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.
Ariane Marie-Mitchell, MD, PhD, MPH principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Three-Tier Model in people with Adverse Childhood Experiences, run by Loma Linda University at 1 site 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 2 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 9 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariane Marie-Mitchell, MD, PhD, MPH (909-651-5672, amariemitchell@llu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child Allostatic Load Index (time frame: Change between baseline and visit 4 (1-year post-enrollment)). 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 9 Jun 2026.