PRE-CARE Intervention for ADHD in Preschoolers

(PRE-CARE Trial)

No longer recruiting at 1 trial location

Overseen By Jennifer Sikov, MA

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment model called PRE-CARE, designed to assist families of preschoolers with ADHD symptoms. The goal is to address social challenges these families might face, which can affect the child's health and development. The trial includes two groups: one receiving usual care and the other receiving the PRE-CARE intervention, which provides personalized support for social needs. Families with a child aged 3-5 showing signs of ADHD who receive care at Boston Medical Center might be suitable for this trial. As an unphased trial, it offers families the chance to contribute to innovative research that could shape future ADHD care strategies.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the PRE-CARE intervention is safe for preschoolers with ADHD symptoms?

Research has shown that the PRE-CARE program, based on the WE CARE model, has been effective in similar situations. This program assists families in managing social challenges that can affect young children with ADHD symptoms. Although specific safety data for PRE-CARE is not available, the WE CARE model has been used successfully without major side effects, suggesting that PRE-CARE is likely safe.

While specific safety results from past studies are lacking, the foundation of PRE-CARE on a trusted model for addressing social needs provides some confidence in its safety. As this trial is in the early stages, researchers are still evaluating the treatment's safety. However, the safety of similar programs in the past is encouraging for prospective participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PRE-CARE intervention for ADHD in preschoolers because it offers a fresh approach by focusing on social needs navigation. Unlike traditional treatments that primarily involve medication or behavioral therapy, PRE-CARE directly addresses the social factors that can worsen ADHD symptoms. This method is based on detailed analyses of how unmet social needs and ADHD are linked, aiming to improve the child’s overall functioning by tackling these root issues. By targeting these underlying factors, PRE-CARE has the potential to enhance existing care strategies and provide a more holistic solution for young children with ADHD.

What evidence suggests that the PRE-CARE intervention might be an effective treatment for ADHD?

Research shows that starting treatment early can help young children with ADHD symptoms. This trial studies a program called PRE-CARE, based on a successful program named WE CARE. The program assists families in managing social stress that might exacerbate ADHD symptoms. Participants in the intervention group will receive the PRE-CARE social needs navigation intervention. Studies have found that programs like this can improve behavior and reduce symptoms in preschoolers with ADHD. Evidence suggests these programs can be more effective than medication for young children at risk for ADHD. Overall, early treatment has demonstrated lasting benefits in managing ADHD symptoms. ^{1 2 6 7 8}

Who Is on the Research Team?

Andrea Spencer, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Are You a Good Fit for This Trial?

This trial is for primary caregivers of low-income preschool children aged 3-5 with ADHD symptoms. Participants must understand English or Spanish, be at least 16 years old, and their child should receive care at Boston Medical Center or affiliated clinics. Eligible kids have an ADHD diagnosis or high scores on the ADHD-Rating Scale.

Inclusion Criteria

My daughter's score is 13 or higher, or her attention/hyperactivity score is 6 or more.

My child, aged 3-5 years, has ADHD or scores high on the ADHD scale.

I am the legal guardian and main caregiver of a child aged 3 to almost 6 years.

Exclusion Criteria

There are no specific exclusion criteria for this study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the PRE-CARE intervention addressing unmet social needs for families of preschool-age children with ADHD symptoms

12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

What Are the Treatments Tested in This Trial?

Interventions

• PRE-CARE

Trial Overview The PRE-CARE model is being tested to help families of young children with ADHD by providing resources and support through a randomized controlled trial. It includes screening, resource packets, navigation assistance, and usual care to address social needs that affect these children's health and development.

How Is the Trial Designed?

Group I: Intervention group- PRE-CARE Experimental Treatment 3 Interventions

Participants will receive the 1:1 PRE-CARE social needs navigation intervention with specific content and delivery strategy which was developed based on 1) quantitative analyses of the association between unmet social needs and ADHD symptoms in a large-scale nationally representative sample of children age 3-5, and 2) in-depth qualitative interviews with parents/guardians of preschoolers with inattention and/or hyperactivity symptoms to identify mechanisms by which unmet social needs exacerbate ADHD symptoms and functioning.

Group II: Control group- Care as Usual Active Control 1 Intervention

Families randomly assigned to the control condition will continue to receive care as usual, which includes screening for social needs annually at well-child visits as recommended by the American Academy of Pediatrics (AAP), followed by provision of information as needed by the family. Families will also be offered the opportunity to make research assessments available to their primary care physician for best continuity of care.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11162428/

Improving the efficacy and effectiveness of evidence-based ... Overall, commercialized BPT and homegrown BPT have been found to be effective in improving the functioning of children with ADHD and their ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8662873/

Long-term effectiveness of behavioural intervention in ... In this study, we show that adding behavioural interventions to traditional treatments effectively improves behaviour and reduces ADHD symptoms ...

3. publications.aap.org publications.aap.org/pediatrics/article/131/5/e1584/31291/Interventions-for-Preschool-Children-at-High-Risk

Interventions for Preschool Children at High Risk for ADHD PBT interventions have greater evidence of effectiveness than methylphenidate for treatment of preschoolers at risk for ADHD.

4. sciencedirect.com sciencedirect.com/science/article/pii/S1878747923017282

Preventive Interventions for ADHD: A Neurodevelopmental ... Early Interventions in ADHD Have Shown Persisting Efficacy. Unlike treatment of ADHD during the school-age years, some preschool interventions provide ...

5. acamh.onlinelibrary.wiley.com acamh.onlinelibrary.wiley.com/doi/10.1002/jcv2.12196

Sustained improvements by behavioural parent training for ... The primary aim of this meta-analysis was to investigate the longer-term outcomes of behavioural parent training for children with ADHD. On both ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03260205

Safety and Efficacy Study in Preschool Children Aged 4-5 ... The purpose of this study is to determine if an investigational treatment is effective in improving the total score on the ADHD-RS-IV Preschool Version

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5720167/

Early Intervention for Preschoolers at Risk for Attention ... Based on parent report, 10 children in the intervention condition responded (39%), six children improved (23%), and six remained unchanged (23%). The remaining ...

8. withpower.com withpower.com/trial/phase-attention-deficit-disorder-with-hyperactivity-10-2021-2e2ae

PRE-CARE Intervention for ADHD in Preschoolers The goal of this proposed study is to pilot test a novel treatment model (PRE-CARE) addressing unmet social needs for families of preschool-age children ...