N/A
Completed N=45
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Attention Deficit Hyperactivity Disorder · Inattention
Source: ClinicalTrials.gov NCT04999982 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: ADHD Symptoms — 27.7; 27.5; 27.7; 34.6 score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY ADHD Symptoms |
27.7; 27.5; 27.7; 34.6; 21.5; 27.6 | — |
| PRIMARY Total Resources Enrolled (Parent Report) |
3.4; 4.1; 4.7; 4.1; 4.7; 4.1 | — |
| SECONDARY Child Psychiatric Symptoms |
62.6; 59.0; 49.0; 51.0; 48.3; 48.1 | — |
| SECONDARY Parental Depression |
7.0; 5.7; 7.1; 8.8; 5.8; 6.3 | — |
| SECONDARY Parental Attention-deficit/Hyperactivity Disorder (ADHD) |
3; 3; 4; 3; 1; 1 | — |
| SECONDARY Global Perceived Stress |
17.1; 20.1; 16.1; 20.1; 16.5; 20.3 | — |
| SECONDARY Parenting Stress |
90.3; 75.6; 98.2; 83.4; 89.9; 86.5 | — |
| SECONDARY PRE-CARE Feasibility and Acceptability Questionnaire |
15; 1; 0; 2; 14; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- There are no specific exclusion criteria for this study
Data sourced from ClinicalTrials.gov (NCT04999982). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.