NCT04999982

Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)

Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Attention Deficit/Hyperactivity Disorder
• Inattention

Interventions

Type	Name	Description
OTHER	Screening	Parent-report screening for remediable, unmet social needs.
OTHER	Resource Packet	Provision of packet of resource sheets ("Family Resource Booklet") detailing local community-based resources to address these needs, with needs that respond to family's requests highlighted.
OTHER	Resource Navigation	Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
OTHER	Care as usual	Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.

Timeline

• Start date: 2021-11-30
• Primary completion: 2024-04-01
• Completion: 2025-04-01
• First posted: 2021-08-11
• Last updated: 2025-09-02
• Results posted: 2025-09-02

Locations

2 sites across 1 country: United States