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

Primary Purpose

Attention Deficit/Hyperactivity Disorder, Inattention

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Screening
Resource Packet
Resource Navigation
Care as usual
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Attention Deficit/Hyperactivity Disorder focused on measuring PRE-CARE, WECARE, Parent, Caregiver, Community health worker

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group- PRE-CARE

Control group- Care as Usual

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
August 3, 2021
Last Updated
May 12, 2023
Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04999982
Brief Title
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Acronym
PRE-CARE
Official Title
Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 30, 2021 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Attention Deficit/Hyperactivity Disorder, Inattention
Keywords
PRE-CARE, WECARE, Parent, Caregiver, Community health worker

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group- PRE-CARE
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group- Care as Usual
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Screening
Intervention Description
Parent-report screening for remediable, unmet social needs.
Intervention Type
Other
Intervention Name(s)
Resource Packet
Intervention Description
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
Intervention Name(s)
Resource Navigation
Intervention Description
Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
Intervention Type
Other
Intervention Name(s)
Care as usual
Intervention Description
Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family.
Primary Outcome Measure Information:
Title
ADHD Symptoms at baseline
Description
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.
Time Frame
Baseline
Title
ADHD Symptoms at 3 months
Description
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.
Time Frame
3 months
Title
ADHD Symptoms at 6 months
Description
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.
Time Frame
6 months
Title
ADHD Symptoms at 12 months
Description
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.
Time Frame
12 months
Title
Child Psychiatric Symptoms at baseline
Description
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.
Time Frame
Baseline
Title
Child Psychiatric Symptoms at 3 months
Description
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.
Time Frame
3 months
Title
Child Psychiatric Symptoms at 12 months
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Unmet Social Needs Outcomes
Description
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.
Time Frame
Baseline, 3 months, 6 months, 12 months
Title
Adverse Childhood Experiences
Description
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.
Time Frame
baseline and 12 months
Title
Parental Depression
Description
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.
Time Frame
baseline, 3 months, 6 months, 12 months
Title
Parental Attention-deficit/hyperactivity disorder (ADHD)
Description
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.
Time Frame
baseline, 3 months, 6 months, 12 months
Title
Global Perceived Stress
Description
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.
Time Frame
baseline, 3 months, 6 months, 12 months
Title
Parenting Stress
Description
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.
Time Frame
baseline, 3 months, 6 months, 12 months
Title
PRE-CARE Feasibility and Acceptability Questionnaire
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Spencer, MD
Organizational Affiliation
Boston Medical Center, Psychiatry Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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