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

NCT04999982 | Completed Results

• 2 other identifiers: IRB 2023-62095K23MH118478-03
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Parent; Caregiver; Community health worker

Outcome Measures

Primary Outcomes (2)

• ADHD Symptoms

  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 reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.

  Baseline, 3 months, 6 months, and 12 months

• Total Resources Enrolled (Parent Report)

  Resource access was measured based on a parent report checklist of resources enrolled. The checklist was based on the Child HealthWatch Survey and modeled after data collected for the clinical trial testing the original social determinants intervention on which this intervention is based. The checklist included 18 resources that families could be enrolled in (for example - healthcare services, mental health care, special education, food benefits, housing assistance, etc), and asked parents to indicate which resources they were enrolled in. The end result is a count between 0 and 18 representing how many resources their family was enrolled in. Higher numbers indicate higher number of resources enrolled, whereas lower numbers indicate lower number of resources enrolled.

  Baseline, 3 months, 6 months, 12 months

Secondary Outcomes (6)

• Child Psychiatric Symptoms

  Baseline, 6 months, 12 months

• Parental Depression

  baseline, 3 months, 6 months, 12 months

• Parental Attention-deficit/Hyperactivity Disorder (ADHD)

  baseline, 3 months, 6 months, 12 months

• Global Perceived Stress

  baseline, 3 months, 6 months, 12 months

• Parenting Stress

  baseline, 3 months, 6 months, 12 months

Study Arms (2)

Intervention group- PRE-CARE

EXPERIMENTAL

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.

Other: Screening; Other: Resource Packet; Other: Resource Navigation

Control group- Care as Usual

ACTIVE COMPARATOR

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.

Other: Care as usual

Interventions

Screening OTHER

Parent-report screening for remediable, unmet social needs.

Intervention group- PRE-CARE

Resource Packet OTHER

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.

Intervention group- PRE-CARE

Resource Navigation OTHER

Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.

Intervention group- PRE-CARE

Care as usual OTHER

Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.

Control group- Care as Usual

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

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

Chicago, Illinois, 60611, United States

Location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Mass Screening

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis; Health Surveys; Surveys and Questionnaires; Data Collection; Epidemiologic Methods; Investigative Techniques; Diagnostic Services; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Public Health Practice

Results Point of Contact

• Title: Dr. Andrea Spencer
• Organization: Ann & Robert H. Lurie Children's Hospital of Chicago

aspencer@luriechildrens.org

3122273402

Study Officials

• Andrea Spencer, MD

  Ann & Robert H Lurie Children's Hospital of Chicago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair for Research

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 11, 2021
• Study Start: November 30, 2021
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2025
• Last Updated: September 2, 2025
• Results First Posted: September 2, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)