Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Key facts
- Who runs it
- Ann & Robert H Lurie Children's Hospital of Chicago
- Where
- Boston and Chicago, United StatesSee the 2 sites
- Trial code
- Status
- Completed
- People taking part
- 54 people enrolled
- Started
- 30 Nov 2021
- Ended
- 1 Apr 2025
- Type of study
- Interventional, 2 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- Screening
- Resource Packet
- Resource Navigation
- Care as usual
- Record updated
- 2 September 2025
Who can take part
- Age
- 16 years and older
- Sex
- Women and men
- Healthy volunteers
- Can take part
The registry criteria, word for word
Show all 6 criteriaShow less
Who can take part
- 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
Who cannot take part
- There are no specific exclusion criteria for this study
Where in United States
- Boston Medical CenterBoston, United States
- Ann & Robert H. Lurie Children's Hospital of ChicagoChicago, United States
About the trial
What the trial wants to find out
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.
Read full original descriptionShow less
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.
The 2 groups in the trial
- Intervention group- PRE-CARETreatment being tested
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: Screening, Resource Packet, and Resource Navigation
- Control group- Care as UsualExisting treatment, for comparison
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: Care as usual
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
- Record updated
- 2 September 2025