PRE-CARE Intervention for ADHD in Preschoolers

(PRE-CARE Trial)

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

55 Participants Needed

Trial Summary

What is the purpose of this trial?

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 with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms. The investigators will conduct an adaptive, pilot randomized controlled trial (RCT) of the intervention with parents of 60 low-income children age 3-5 (36-71 months) with ADHD symptoms in order to: optimize intervention delivery; field test study logistics (e.g., recruitment, enrollment, randomization, retention); explore putative intervention mechanisms; and obtain estimates of study parameters to plan an appropriately powered RCT of the intervention. The PRE-CARE intervention is adapted from Well Child Care, Evaluation, Community, Resources, Advocacy, Referral, Education (WE CARE), a screening and referral intervention that has been shown to be feasible and effective in addressing the family psychosocial stressors of low-income families seen in pediatric medical homes. Given the negative impact that socioeconomic stressors can have on the health and development of young children with ADHD symptoms, tailored interventions such as PRE-CARE may serve as a vital early intervention strategy to promote long-term well-being.

Research Team

Andrea Spencer, MD

Principal Investigator

Ann & Robert H Lurie Children's Hospital of Chicago

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+