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PRE-CARE Intervention for ADHD in Preschoolers (PRE-CARE Trial)

N/A
Waitlist Available
Led By Andrea Spencer, MD
Research Sponsored by Boston Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
For female children, a total score ≥ 13 OR subscale score (inattention and/or hyperactivity) ≥ 6 for female children
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 3 months, 6 months, 12 months
Awards & highlights

PRE-CARE Trial Summary

This trial will test a new intervention model (PRE-CARE) addressing unmet social needs for families of preschool-age children with Attention Deficit/Hyperactivity Disorder (ADHD) symptoms.

Who is the study for?
This trial is for primary caregivers of low-income preschool children aged 3-5 with ADHD symptoms. Participants must understand English or Spanish, be at least 16 years old, and their child should receive care at Boston Medical Center or affiliated clinics. Eligible kids have an ADHD diagnosis or high scores on the ADHD-Rating Scale.Check my eligibility
What is being tested?
The PRE-CARE model is being tested to help families of young children with ADHD by providing resources and support through a randomized controlled trial. It includes screening, resource packets, navigation assistance, and usual care to address social needs that affect these children's health and development.See study design
What are the potential side effects?
Since this intervention involves non-medical support such as resource guidance rather than drugs or medical procedures, there are no direct physical side effects expected from participating in this study.

PRE-CARE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My daughter's score is 13 or higher, or her attention/hyperactivity score is 6 or more.
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My child, aged 3-5 years, has ADHD or scores high on the ADHD scale.
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I understand English or Spanish for medical consent.
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I am the legal guardian and main caregiver of a child aged 3 to almost 6 years.
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I am the legal guardian and main caregiver of a child aged 3 to almost 6 years.
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My caregiver is at least 16 years old.
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My caregiver is at least 16 years old.
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I understand informed consent procedures in English or Spanish.
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My child's score is 25 or higher, or their attention/hyperactivity score is 12 or higher.

PRE-CARE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 3 months, 6 months, 12 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 3 months, 6 months, 12 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
ADHD Symptoms at 12 months
ADHD Symptoms at 3 months
ADHD Symptoms at 6 months
+4 more
Secondary outcome measures
Adverse Childhood Experiences
Global Perceived Stress
PRE-CARE Feasibility and Acceptability Questionnaire
+4 more

PRE-CARE Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention group- PRE-CAREExperimental Treatment3 Interventions
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.
Group II: Control group- Care as UsualActive Control1 Intervention
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.

Find a Location

Who is running the clinical trial?

Boston Medical CenterLead Sponsor
382 Previous Clinical Trials
869,392 Total Patients Enrolled
1 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
156 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
National Institute of Mental Health (NIMH)NIH
2,773 Previous Clinical Trials
2,674,248 Total Patients Enrolled
94 Trials studying Attention Deficit Hyperactivity Disorder (ADHD)
19,992 Patients Enrolled for Attention Deficit Hyperactivity Disorder (ADHD)
Andrea Spencer, MDPrincipal InvestigatorBoston Medical Center, Psychiatry Department

Media Library

PRE-CARE Clinical Trial Eligibility Overview. Trial Name: NCT04999982 — N/A
Attention Deficit Hyperactivity Disorder (ADHD) Research Study Groups: Control group- Care as Usual, Intervention group- PRE-CARE
Attention Deficit Hyperactivity Disorder (ADHD) Clinical Trial 2023: PRE-CARE Highlights & Side Effects. Trial Name: NCT04999982 — N/A
PRE-CARE 2023 Treatment Timeline for Medical Study. Trial Name: NCT04999982 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the present capacity of this clinical trial for participants?

"Confirmed. Clinicaltrials.gov exhibits that this research project is still actively seeking out participants - having first been announced on November 30th 2021 and last updated on the 26th of November 2022. The investigators are looking to recruit a total of 60 volunteers from one single location."

Answered by AI

What are the key goals of this clinical experiment?

"This medical study, which is estimated to last for 6 months and will be assessed at 12 months, has two primary objectives. The first of these is measuring ADHD Symptoms with the Adult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist; a set of 18 questions scored on a 5-point Likert scale that can determine if DSM-IV criteria are met in regards to adult Attention Deficit Hyperactivity Disorder (ADHD). Additionally, the PRE-CARE Feasibility and Acceptability Questionnaire looks into satisfaction levels of different aspects via 14 items rated on 4 point scales as well as"

Answered by AI

Is recruitment for this research still accepting new participants?

"Affirmative. Clinicaltrials.gov shows that this clinical trial is still searching for volunteers, with it being originally posted on November 30th 2021 and edited most recently on November 26th 2022. The study requires the aid of 60 patients across 1 centre."

Answered by AI

Who else is applying?

What state do they live in?
Illinois
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~0 spots leftby Apr 2024