Attention Deficit/Hyperactivity DisorderPRE-CARENCT04999982
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
A study testing Screening, Resource Packet and Resource Navigation in people with Attention Deficit/Hyperactivity Disorder and Inattention, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Attention Deficit/Hyperactivity Disorder, Inattention
- What is being tested?
- Screening, Resource Packet and Resource Navigation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Nov 2021to 1 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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 join
- There are no specific exclusion criteria for this study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Boston Medical Center
Boston, Massachusetts, 02118
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
Official title: Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
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.
- Being tested
- Screening, Resource Packet, Resource Navigation, Care as usual
- Keywords
- Parent, Caregiver, Community health worker
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ScreeningOther
Parent-report screening for remediable, unmet social needs.
Resource PacketOther
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.
Resource NavigationOther
Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
Care as usualOther
Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Care as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 3 months, 6 months, 12 months
Secondary outcomes (6)
Child Psychiatric Symptoms
The Child Behavior Checklist 1.5-5 (CBCL 1.5/5) is a standardized tool used to assess child psychiatric symptoms for children 1.5-5 years old. The questionnaire obtains caregivers' ratings of 99 problem items along a Likert scale. Parents/caregivers rate each item 0=not true, 1=somewhat or sometimes true, 2=very true or often true of the child (based on the preceding 6 months). Higher scores are correlated with more psychiatric symptoms. Items can be grouped into syndrome scales or the total score can be used to represent overall psychiatric symptom severity. Here we use the total score to represent total psychiatric symptoms. Scores are reported as t-scores, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate more symptoms. On this scale, scores between 65 and 69 are considered borderline elevated, and scores of 70 or more are considered clinically significant.
Measured: Baseline, 6 months, 12 months
Parental Depression
Patient Health Questionnaire (PHQ)-9 will be used to measure frequency and severity of parental symptoms of depression within the past two weeks. The measure is the major depressive disorder (MDD) module of the full PHQ, and scores each of the 9 Diagnostic and Statistical Manual criteria of MDD as "0" (not at all) to "3" (nearly every day), providing a 0-27 severity score. Higher scores are correlated with more parental depression.
Measured: baseline, 3 months, 6 months, 12 months
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist will be used to measure parent ADHD symptoms. The measure consists of 18 items matching Diagnostic and Statistical Manual IV criteria for adult ADHD. Items are scored on a 5-point Likert scale, (Never, Rarely, Sometimes, Often, Very Often). The questionnaire is scored based on number of symptoms, leadng to a score between 0 and 18 for the questionnaire. Items 1, 2, 3, 9, 12, 16, 18 are each counted as a symptom (1 point each) if the participant answers Sometimes, Often, or Very Often. Items 4, 5, 6, 7, 8, 10, 11, 13, 14, 15, 17 are each counted as a symptom (1 point each) if the participant answers Often or Very Often. Higher scores indicate higher symptom burden.
Measured: baseline, 3 months, 6 months, 12 months
Global Perceived Stress
The Perceived Stress Scale (PSS) will be used to measure perceptions of levels of stress within the past month using 10 items on a 4 point Likert scale indicating 0 = Never, 1 = Almost Never, 2 = Sometimes, 3 = Fairly Often, and 4 = Very Often. Higher scores [range 0 to 40] are correlated with more perceived stress.
Measured: baseline, 3 months, 6 months, 12 months
Parenting Stress
The Parenting Stress Inventory, Short Form (PSI-4-SF) will be used to measure specific levels of stress in relation to taking care of their child and the parent-child system. The scale includes 36 items, each of which uses a 4-point Likert scale from Strongly Disagree to Strongly Agree. The scale includes subscales and a Total score representing total stress on parents, reported here. Possible scores range from 36 to 180. Higher scores are correlated with more parental stress.
Measured: baseline, 3 months, 6 months, 12 months
PRE-CARE Feasibility and Acceptability Questionnaire
The PRE-CARE Feasibility and Acceptability Questionnaire will be used to measure intervention satisfaction using 14 items on a 4 point Likert scale. Items will ask about satisfaction of information and resources provided, length of intervention, perceived helpfulness of intervention, and whether or not they would recommend the program to a parent of a similarly aged child. Higher scores are correlate with greater satisfaction.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2021
- Study start30 Nov 2021
- Primary completion1 Apr 2024
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Attention Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Andrea Spencer, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Andrea Spencer, MD, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04999982
- Sponsor's protocol ID
- IRB 2023-6209
- Other IDs
- 5K23MH118478-03
- Acronym
- PRE-CARE
- Status last verified
- Aug 2025
- First submitted
- 3 Aug 2021
- Last updated
- 2 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
- ClinicalTrials.gov ID
- NCT04999982
- Acronym / sponsor ID
- PRE-CARE / IRB 2023-6209
- Keywords
- Parent, Caregiver, Community health worker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 30 Nov 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 11 Aug 2021 (actual)
- Results
- Posted 2 Sep 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group- PRE-CARE | Experimental | Other: Screening, Other: Resource Packet, Other: Resource NavigationParticipants 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. |
| Control group- Care as Usual | Active comparator | Other: Care as usualFamilies 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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:
Key exclusion criteria (1 listed)
- There are no specific exclusion criteria for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ScreeningParent-report screening for remediable, unmet social needs. | Other | Intervention group- PRE-CARE |
| Resource PacketProvision 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 | Intervention group- PRE-CARE |
| Resource NavigationNavigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist. | Other | Intervention group- PRE-CARE |
| Care as usualScreening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family. | Other | Control group- Care as Usual |
Primary outcome
ADHD Symptoms
Time frame: Baseline, 3 months, 6 months, and 12 months
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.
Total Resources Enrolled (Parent Report)
Time frame: Baseline, 3 months, 6 months, 12 months
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.
6 secondary outcomes
Child Psychiatric Symptoms
Time frame: Baseline, 6 months, 12 months
Parental Depression
Time frame: baseline, 3 months, 6 months, 12 months
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
Time frame: baseline, 3 months, 6 months, 12 months
Global Perceived Stress
Time frame: baseline, 3 months, 6 months, 12 months
Parenting Stress
Time frame: baseline, 3 months, 6 months, 12 months
PRE-CARE Feasibility and Acceptability Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Spencer, MD principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening, Resource Packet and Resource Navigation in people with Attention Deficit/Hyperactivity Disorder and Inattention, run by Ann & Robert H Lurie Children's Hospital of Chicago at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ADHD Symptoms (time frame: Baseline, 3 months, 6 months, and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2025.