Clinical trial NCT04999982: Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Official title: Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Attention Deficit/Hyperactivity Disorder
Inattention
Keywords: PRE-CARE
WECARE
Parent
Caregiver
Community health worker
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2021-08-11
Enrollment: 55
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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 Boston HealthNet 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

Primary outcomes:
measure: ADHD Symptoms at baseline
timeFrame: Baseline
measure: ADHD Symptoms at 3 months
timeFrame: 3 months
measure: ADHD Symptoms at 6 months
timeFrame: 6 months
measure: ADHD Symptoms at 12 months
timeFrame: 12 months
measure: Child Psychiatric Symptoms at baseline
timeFrame: Baseline
measure: Child Psychiatric Symptoms at 3 months
timeFrame: 3 months
measure: Child Psychiatric Symptoms at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: Unmet Social Needs Outcomes
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Adverse Childhood Experiences
timeFrame: baseline and 12 months
measure: Parental Depression
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Parental Attention-deficit/hyperactivity disorder (ADHD)
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Global Perceived Stress
timeFrame: baseline, 3 months, 6 months, 12 months
measure: Parenting Stress
timeFrame: baseline, 3 months, 6 months, 12 months
measure: PRE-CARE Feasibility and Acceptability Questionnaire
timeFrame: 3 months
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H. Lurie Children's Hospital of Chicago
state: Illinois
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Ann & Robert H Lurie Children's Hospital of Chicago
name: Andrea Spencer, MD
role: PRINCIPAL_INVESTIGATOR
References: