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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Preference and Goal Directed Attention Deficit Hyperactivity Disorder Care- Pilot Study

NCT01487967

Attention Deficit Hyperactivity Disorder

COMPLETED NA

Improving Attention Deficit Hyperactivity Disorder Treatment Adherence and Outcome in Primary Care Settings

NCT00179894

Attention Deficit Disorder With Hyperactivity

COMPLETED NA

Improving the Outcomes of Adolescents With ADHD Via a Pre-visit Question Prompt List/Video Intervention

NCT05835362

ADHD

COMPLETED NA

Autonomic Correlates of Impulsivity for Preschool Children With Attention Deficit Hyperactivity Disorder (ADHD)

NCT00856063

Attention Deficit Hyperactivity Disorder

COMPLETED PHASE4

Evaluating Clinical Outcomes of Treatment Effectiveness for Children and Adults With ADHD

NCT00307268

Attention-Deficit/Hyperactivity Disorder (ADHD)

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Attention Deficit/Hyperactivity Disorder Inattention

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intervention group- PRE-CARE

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 Type EXPERIMENTAL

Screening

Intervention Type OTHER

Parent-report screening for remediable, unmet social needs.

Resource Packet

Intervention Type 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.

Resource Navigation

Intervention Type OTHER

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

Control group- Care as Usual

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.

Group Type ACTIVE_COMPARATOR

Care as usual

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Screening

Parent-report screening for remediable, unmet social needs.

Intervention Type OTHER

Resource Packet

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 Type OTHER

Resource Navigation

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

Intervention Type OTHER

Care as usual

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes