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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity

Conditions
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Attention Deficit/Hyperactivity Disorder, Inattention

Intervention / Treatment
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* Other: Screening
* Other: Resource Packet
* Other: Resource Navigation
* Other: Care as usual


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group- PRE-CARE<br>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<br>* Parent-report screening for remediable, unmet social needs.<br>Other: Resource Packet<br>* 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.<br>Other: Resource Navigation<br>* Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.<br>|
| Active Comparator: Control group- Care as Usual<br>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<br>* Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Caregiver, PRE-CARE, WECARE, Parent, Community health worker