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NCT04999982 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

Completed
Registry status
NA
Development phase
54
Enrollment target

NCT04999982: Completed NA study, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

NCT04999982 is a NA study that has completed, run by Ann & Robert H Lurie Children's Hospital of Chicago. The registered enrollment target is 54 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04999982, a NA study, has completed, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago.

COMPLETED
Registry status
NA
Development phase
54 participants
Enrollment target

Study 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.

Primary Outcome

ADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are

Interventions

  • OTHER Screening
  • OTHER Care as usual
  • OTHER Resource Navigation
  • OTHER Resource Packet

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2021-11-30
Est. Completion 2025-04-01
Phase NA

What the finished NCT04999982 record still lists

NCT04999982 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 4 interventions - of which Screening is the first listed.

NCT04999982 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04999982 about?

NCT04999982 is a clinical study titled "Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)". 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) ...

What is the current status of trial NCT04999982?

This trial is currently completed. It is a NA study. The enrollment target is 54 participants. The study started on 2021-11-30. Estimated completion is 2025-04-01.

What interventions are being tested in trial NCT04999982?

The interventions under investigation include: Screening (OTHER), Care as usual (OTHER), Resource Navigation (OTHER), Resource Packet (OTHER).

Who is sponsoring clinical trial NCT04999982?

This trial is sponsored by Ann & Robert H Lurie Children's Hospital of Chicago, which has 159 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04999982's enrollment target sits among peer trials

54 1268th of 2000 higher than 730 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04999982, the US trial registry maintained by the National Library of Medicine. NCT04999982 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.