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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Attention Deficit/Hyperactivity Disorder; Inattention
• Intervention / Treatment: Other: Screening; Other: Resource Packet; Other: Resource Navigation; Other: Care as usual

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrea Spencer, MD; Phone Number: 617-414-1932; Email: andrea.spencer@bmc.org
• Study Contact Backup: Name: Jennifer Sikov, MA; Phone Number: 617-638-8541; Email: jennifer.sikov@bmc.org

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Other: Screening; Parent-report screening for remediable, unmet social needs.; 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.; Other: Resource Navigation; Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ADHD Symptoms at baseline	ADHD-Rating Scale (RS)-IV Preschool Version will be used to assess ADHD Symptoms. The 18 item scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Responses for each item can be 0 to 3 where 0= rarely or never and 3= Very often. Each subscale can have a range of 0 to 27 with higher scores correlated with more frequent symptoms.	Baseline
ADHD Symptoms at 3 months	ADHD-Rating Scale (RS)-IV Preschool Version will be used to assess ADHD Symptoms. The 18 item scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Responses for each item can be 0 to 3 where 0= rarely or never and 3= Very often. Each sub-scale can have a range of 0 to 27 with higher scores correlated with more frequent symptoms.	3 months
ADHD Symptoms at 6 months	ADHD-Rating Scale (RS)-IV Preschool Version will be used to assess ADHD Symptoms. The 18 item scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Responses for each item can be 0 to 3 where 0= rarely or never and 3= Very often. Each subscale can have a range of 0 to 27 with higher scores correlated with more frequent symptoms.	6 months
ADHD Symptoms at 12 months	ADHD-Rating Scale (RS)-IV Preschool Version will be used to assess ADHD Symptoms. The 18 item scale consists of 2 subscales: inattention (9 items) and hyperactivity-impulsivity (9 items). Responses for each item can be 0 to 3 where 0= rarely or never and 3= Very often. Each subscale can have a range of 0 to 27 with higher scores correlated with more frequent symptoms.	12 months
Child Psychiatric Symptoms at baseline	The Child Behavior Checklist 1.5-5 (CBCL 1.5/5) will be used to assess child psychiatric symptoms which obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. 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 two months). Higher scores are correlated with more psychiatric symptoms.	Baseline
Child Psychiatric Symptoms at 3 months	The Child Behavior Checklist 1.5-5 (CBCL 1.5/5) will be used to assess child psychiatric symptoms which obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. 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 two months). Higher scores are correlated with more psychiatric symptoms.	3 months
Child Psychiatric Symptoms at 12 months	The Child Behavior Checklist 1.5-5 (CBCL 1.5/5) will be used to assess child psychiatric symptoms which obtains caregivers' ratings of 99 problem items. Items are scored on the following syndrome scales: Emotionally Reactive, Anxious/Depressed, Somatic Complaints, Withdrawn, Attention Problems, Aggressive Behavior, and Sleep Problems. 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 two months). Higher scores are correlated with more psychiatric symptoms.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unmet Social Needs Outcomes	Family unmet Social Needs Access, Utilization, and Adequacy of Resources will be measured using items from the Children's Health Watch Vital Signs and National Survey of Children's Health pertaining to all unmet needs in the PRECARE Screener.	Baseline, 3 months, 6 months, 12 months
Adverse Childhood Experiences	The Adverse Childhood Experiences (CYW ACE-Q) Questionnaire will be used to measure cumulative child exposure to 17 stressful or traumatic events including abuse, neglect, and household dysfunction, as reported by the parent. Higher scores are correlated with more adverse childhood experiences.	baseline and 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 DSM 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.	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 DSM-IV criteria found to be the most predictive of symptoms consistent with adult ADHD. Items are scored on a 5-point Likert scale, from Never to Very Often. Higher scores are correlated with more parental ADHD symptoms.	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.	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, using a 4-point Likert scale from Strongly Disagree to Strongly Agree. Higher scores are correlated with more parental stress.	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.	3 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Andrea Spencer, MD, Boston Medical Center, Psychiatry Department

Study record dates

Study Major Dates

• Study Start (Actual): November 30, 2021
• Primary Completion (Anticipated): April 1, 2024
• Study Completion (Anticipated): April 1, 2024

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: August 3, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 12, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Caregiver; Parent; WECARE; Community health worker; PRE-CARE
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Dyskinesias; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity; Hyperkinesis
• Other Study ID Numbers: H-41211; 5K23MH118478-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No