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

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

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.

Sponsors & Collaborators

• National Institute of Mental Health (NIMH)

  collaborator NIH

• Ann & Robert H Lurie Children's Hospital of Chicago

  lead OTHER

Principal Investigators

• Andrea Spencer, MD · Ann & Robert H Lurie Children's Hospital of Chicago

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-11-30

Primary Completion

2024-04-01

Completion

2025-04-01

Countries

• United States

Study Locations