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

Ann & Robert H Lurie Children's Hospital of Chicago

Status: Completed

Conditions: Inattention; Attention Deficit/Hyperactivity Disorder

Treatments: Other: Resource Navigation; Other: Care as usual; Other: Screening; Other: Resource Packet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04999982

IRB 2023-6209

5K23MH118478-03 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Enrollment: 54 patients

Sex: All

Ages: 16+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Legal guardian and primary caregiver of a child aged 36-71 months

• Legal guardian or primary caregiver is age 16 years or older

• Child receives pediatric care at Boston Medical Center or at one of the participating affiliated clinics

• Able to understand informed consent procedures in English or Spanish

• Participant has a child aged 36-71 months with an ADHD diagnosis, OR one elevated total or subscale score at the 80th percentile on the ADHD-Rating Scale-IV Preschool Version. 80th percentile cut-offs on the ADHD-Rating Scale-IV Preschool Version are as follows:

  • For male children, a total score ≥ 25 OR subscale score (inattention and/or hyperactivity) ≥ 12
  • For female children, a total score ≥ 13 OR subscale score (inattention and/or hyperactivity) ≥ 6 for female children

Exclusion criteria

• There are no specific exclusion criteria for this study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Intervention group- PRE-CARE

Experimental group

Description:

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.

Treatment:

Other: Resource Packet

Other: Screening

Other: Resource Navigation

Control group- Care as Usual

Active Comparator group

Description:

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.

Treatment:

Other: Care as usual