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

• ClinicalTrials.gov Identifier: NCT04999982
• Recruitment Status: Recruiting
• First Posted: August 11, 2021
• Last Update Posted: November 29, 2022
• Sponsor: Boston Medical Center
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Boston Medical Center

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.

Condition or disease	Intervention/treatment	Phase
Attention Deficit/Hyperactivity Disorder; Inattention	Other: Screening; Other: Resource Packet; Other: Resource Navigation; Other: Care as usual	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Testing PRE-CARE to Address Unmet Social Needs for Preschoolers With Inattention and/or Hyperactivity
• Actual Study Start Date: November 30, 2021
• Estimated Primary Completion Date: March 2023
• Estimated Study Completion Date: March 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. ADHD Symptoms at baseline [ Time Frame: 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.
2. ADHD Symptoms at 3 months [ Time Frame: 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. ADHD Symptoms at 6 months [ Time Frame: 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.
4. ADHD Symptoms at 12 months [ Time Frame: 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.
5. Child Psychiatric Symptoms at baseline [ Time Frame: 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.
6. Child Psychiatric Symptoms at 3 months [ Time Frame: 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.
7. Child Psychiatric Symptoms at 12 months [ Time Frame: 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 :

1. Unmet Social Needs Outcomes [ Time Frame: Baseline, 3 months, 6 months, 12 months ]
   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.
2. Adverse Childhood Experiences [ Time Frame: baseline and 12 months ]
   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.
3. Parental Depression [ Time Frame: baseline, 3 months, 6 months, 12 months ]
   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.
4. Parental Attention-deficit/hyperactivity disorder (ADHD) [ Time Frame: baseline, 3 months, 6 months, 12 months ]
   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.
5. Global Perceived Stress [ Time Frame: baseline, 3 months, 6 months, 12 months ]
   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.
6. Parenting Stress [ Time Frame: baseline, 3 months, 6 months, 12 months ]
   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.
7. PRE-CARE Feasibility and Acceptability Questionnaire [ Time Frame: 3 months ]
   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.

Eligibility Criteria

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

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

Contacts and Locations

Contacts

Contact: Andrea Spencer, MD; 617-414-1932; andrea.spencer@bmc.org

Contact: Jennifer Sikov, MA; 617-638-8541; jennifer.sikov@bmc.org

Locations

United States, Massachusetts

Boston Medical Center; Recruiting

Boston, Massachusetts, United States, 02118

Contact: Andrea Spencer, MD 617-414-1932 andrea.spencer@bmc.org

Contact: Jennifer Sikov, MA 617-638-8541 jennifer.sikov@bmc.org

Sponsors and Collaborators

Boston Medical Center

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Andrea Spencer, MD; Boston Medical Center, Psychiatry Department

More Information

• Responsible Party: Boston Medical Center
• ClinicalTrials.gov Identifier: NCT04999982
• Other Study ID Numbers: H-41211; 5K23MH118478-03 ( U.S. NIH Grant/Contract )
• First Posted: August 11, 2021
• Last Update Posted: November 29, 2022
• Last Verified: November 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Boston Medical Center:

PRE-CARE; WECARE; Parent; Caregiver; Community health worker

Additional relevant MeSH terms:

Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders; Dyskinesias; Neurologic Manifestations; Nervous System Diseases