Trial Outcomes & Findings for Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE) (NCT NCT04999982)
NCT ID: NCT04999982
Last Updated: 2025-09-02
Results Overview
ADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
Baseline, 3 months, 6 months, and 12 months
Results posted on
2025-09-02
Participant Flow
We enrolled 54 parents but only 45 parents were ultimately randomized, hence the discrepancy between enrollment and participant flow.
Participant milestones
| Measure |
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
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.
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.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
23
|
|
Overall Study
COMPLETED
|
16
|
17
|
|
Overall Study
NOT COMPLETED
|
6
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Pilot Testing PREschooler Care, Community Resources, Advocacy, Referral, Education (PRE-CARE)
Baseline characteristics by cohort
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
35.0 years
n=5 Participants
|
32.0 years
n=7 Participants
|
34.0 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
10 participants
n=5 Participants
|
10 participants
n=7 Participants
|
20 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic Black
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic White
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
2 participants
n=5 Participants
|
1 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other race
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, and 12 monthsADHD-Rating Scale (RS)-IV Preschool Version is a parent-report survey that measures presence and severity of ADHD symptoms for preschoolers. In our study, we used this measure to assess overall ADHD symptom burden. The 18-item validated scale asks parents about the 18 diagnostic criteria for ADHD and how often their child exhibits each symptom. The scale can be used as an overall score (total symptoms) or by subscales (9-item inattention subscale and 9-item hyperactivity subscale). Responses are reported by parents for each item along a 4-point Likert scale from 0 to 3, where 0=rarely or never and 3=very often. For our purposes, we computer the total score for a measure of total ADHD symptom severity, and did not use the subscales. Total scores range from 0 to 54, where lower is less ADHD symptoms/lower symptom severity, and higher scores represent higher symptom severity.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
ADHD Symptoms
Baseline
|
27.7 score on a scale
Standard Deviation 15.5
|
27.5 score on a scale
Standard Deviation 14.4
|
|
ADHD Symptoms
3 months
|
27.7 score on a scale
Standard Deviation 17.9
|
34.6 score on a scale
Standard Deviation 14.2
|
|
ADHD Symptoms
6 months
|
21.5 score on a scale
Standard Deviation 15.2
|
27.6 score on a scale
Standard Deviation 16.7
|
|
ADHD Symptoms
12 months
|
21.0 score on a scale
Standard Deviation 16.8
|
23.8 score on a scale
Standard Deviation 16.5
|
PRIMARY outcome
Timeframe: Baseline, 3 months, 6 months, 12 monthsResource access was measured based on a parent report checklist of resources enrolled. The checklist was based on the Child HealthWatch Survey and modeled after data collected for the clinical trial testing the original social determinants intervention on which this intervention is based. The checklist included 18 resources that families could be enrolled in (for example - healthcare services, mental health care, special education, food benefits, housing assistance, etc), and asked parents to indicate which resources they were enrolled in. The end result is a count between 0 and 18 representing how many resources their family was enrolled in. Higher numbers indicate higher number of resources enrolled, whereas lower numbers indicate lower number of resources enrolled.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Total Resources Enrolled (Parent Report)
Baseline
|
3.4 units on a scale
Standard Deviation 2.3
|
4.1 units on a scale
Standard Deviation 2.7
|
|
Total Resources Enrolled (Parent Report)
3 months
|
4.7 units on a scale
Standard Deviation 2.7
|
4.1 units on a scale
Standard Deviation 2.3
|
|
Total Resources Enrolled (Parent Report)
6 months
|
4.7 units on a scale
Standard Deviation 3.1
|
4.1 units on a scale
Standard Deviation 2.4
|
|
Total Resources Enrolled (Parent Report)
12 months
|
4.3 units on a scale
Standard Deviation 2.5
|
4.6 units on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: Baseline, 6 months, 12 monthsThe Child Behavior Checklist 1.5-5 (CBCL 1.5/5) is a standardized tool used to assess child psychiatric symptoms for children 1.5-5 years old. The questionnaire obtains caregivers' ratings of 99 problem items along a Likert scale. 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 6 months). Higher scores are correlated with more psychiatric symptoms. Items can be grouped into syndrome scales or the total score can be used to represent overall psychiatric symptom severity. Here we use the total score to represent total psychiatric symptoms. Scores are reported as t-scores, where 50 indicates the population mean with a standard deviation of 10. Higher scores indicate more symptoms. On this scale, scores between 65 and 69 are considered borderline elevated, and scores of 70 or more are considered clinically significant.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Child Psychiatric Symptoms
Baseline
|
62.6 T-score
Standard Deviation 13.8
|
59.0 T-score
Standard Deviation 15.0
|
|
Child Psychiatric Symptoms
6 months
|
49.0 T-score
Standard Deviation 16.0
|
51.0 T-score
Standard Deviation 19.6
|
|
Child Psychiatric Symptoms
12 months
|
48.3 T-score
Standard Deviation 17.2
|
48.1 T-score
Standard Deviation 18.5
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsPatient 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 Diagnostic and Statistical Manual 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.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Parental Depression
Baseline
|
7.0 score on a scale
Standard Deviation 6.7
|
5.7 score on a scale
Standard Deviation 5.8
|
|
Parental Depression
3 months
|
7.1 score on a scale
Standard Deviation 7.5
|
8.8 score on a scale
Standard Deviation 8.5
|
|
Parental Depression
6 months
|
5.8 score on a scale
Standard Deviation 5.3
|
6.3 score on a scale
Standard Deviation 6.7
|
|
Parental Depression
12 months
|
6.6 score on a scale
Standard Deviation 6.1
|
6.9 score on a scale
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsAdult ADHD Self-Report Scale (ASRS-v1.1) Symptom Checklist will be used to measure parent ADHD symptoms. The measure consists of 18 items matching Diagnostic and Statistical Manual IV criteria for adult ADHD. Items are scored on a 5-point Likert scale, (Never, Rarely, Sometimes, Often, Very Often). The questionnaire is scored based on number of symptoms, leadng to a score between 0 and 18 for the questionnaire. Items 1, 2, 3, 9, 12, 16, 18 are each counted as a symptom (1 point each) if the participant answers Sometimes, Often, or Very Often. Items 4, 5, 6, 7, 8, 10, 11, 13, 14, 15, 17 are each counted as a symptom (1 point each) if the participant answers Often or Very Often. Higher scores indicate higher symptom burden.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
Baseline
|
3 score on a scale
Interval 1.0 to 6.0
|
3 score on a scale
Interval 0.0 to 6.0
|
|
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
3 months
|
4 score on a scale
Interval 0.0 to 5.0
|
3 score on a scale
Interval 0.0 to 6.0
|
|
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
6 months
|
1 score on a scale
Interval 0.0 to 4.0
|
1 score on a scale
Interval 0.0 to 5.0
|
|
Parental Attention-deficit/Hyperactivity Disorder (ADHD)
12 months
|
1 score on a scale
Interval 0.0 to 6.0
|
0 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsThe 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.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Global Perceived Stress
Baseline
|
17.1 score on a scale
Standard Deviation 5.0
|
20.1 score on a scale
Standard Deviation 5.4
|
|
Global Perceived Stress
3 Months
|
16.1 score on a scale
Standard Deviation 5.1
|
20.1 score on a scale
Standard Deviation 4.2
|
|
Global Perceived Stress
6 months
|
16.5 score on a scale
Standard Deviation 7.0
|
20.3 score on a scale
Standard Deviation 5.9
|
|
Global Perceived Stress
12 months
|
16.1 score on a scale
Standard Deviation 5.6
|
19.5 score on a scale
Standard Deviation 4.7
|
SECONDARY outcome
Timeframe: baseline, 3 months, 6 months, 12 monthsThe 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. The scale includes 36 items, each of which uses a 4-point Likert scale from Strongly Disagree to Strongly Agree. The scale includes subscales and a Total score representing total stress on parents, reported here. Possible scores range from 36 to 180. Higher scores are correlated with more parental stress.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=22 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
Control Group- Care as Usual
n=23 Participants
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.
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.
|
|---|---|---|
|
Parenting Stress
Baseline
|
90.3 score on a scale
Standard Deviation 24.6
|
75.6 score on a scale
Standard Deviation 30.6
|
|
Parenting Stress
3 months
|
98.2 score on a scale
Standard Deviation 23.8
|
83.4 score on a scale
Standard Deviation 22.2
|
|
Parenting Stress
6 months
|
89.9 score on a scale
Standard Deviation 29.8
|
86.5 score on a scale
Standard Deviation 17.9
|
|
Parenting Stress
12 months
|
93.5 score on a scale
Standard Deviation 25.1
|
87.1 score on a scale
Standard Deviation 22.2
|
SECONDARY outcome
Timeframe: 3 monthsPopulation: Reporting percent of participants who agreed or strongly disagreed with each item
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.
Outcome measures
| Measure |
Intervention Group- PRE-CARE
n=16 Participants
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.
Screening: Parent-report screening for remediable, unmet social needs.
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.
Resource Navigation: Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist.
|
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.
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.
|
|---|---|---|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE helped me to access resources for my family · Agree/Strongly Agree
|
15 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE helped me to access resources for my family · Disagree/Strongly Disagree
|
1 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE helped me to access resources for my family · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was not necessary for me and my child · Agree/Strongly Agree
|
2 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was not necessary for me and my child · Disagree/Strongly Disagree
|
14 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was not necessary for me and my child · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the information provided in the family resource booklet · Agree/Strongly Agree
|
16 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the information provided in the family resource booklet · Disagree/Strongly Disagree
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the information provided in the family resource booklet · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the service provided in PRE-CARE · Agree/Strongly Agree
|
16 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the service provided in PRE-CARE · Disagree/Strongly Disagree
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the service provided in PRE-CARE · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think the family resource booklet was clear and easy to understand · Agree/Strongly Agree
|
16 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think the family resource booklet was clear and easy to understand · Disagree/Strongly Disagree
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think the family resource booklet was clear and easy to understand · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was too much information provided · Agree/Strongly Agree
|
4 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was too much information provided · Disagree/Strongly Disagree
|
12 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was too much information provided · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was not enough information provided · Agree/Strongly Agree
|
5 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was not enough information provided · Disagree/Strongly Disagree
|
11 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I think there was not enough information provided · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the quality of PRE-CARE · Agree/Strongly Agree
|
16 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the quality of PRE-CARE · Disagree/Strongly Disagree
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I was satisfied with the quality of PRE-CARE · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I had no difficulty understanding the information provided during PRE-CARE · Agree/Strongly Agree
|
15 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I had no difficulty understanding the information provided during PRE-CARE · Disagree/Strongly Disagree
|
1 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I had no difficulty understanding the information provided during PRE-CARE · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was too short · Disagree/Strongly Disagree
|
9 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was too short · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE took too much time · Agree/Strongly Agree
|
2 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE took too much time · Disagree/Strongly Disagree
|
13 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE took too much time · Missing
|
1 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
The resources I received will not improve my child's health or symptoms · Agree/Strongly Agree
|
4 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
The resources I received will not improve my child's health or symptoms · Disagree/Strongly Disagree
|
12 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
The resources I received will not improve my child's health or symptoms · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I would recommend PRE-CARE to another parent of a preschool-age child · Agree/Strongly Agree
|
16 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I would recommend PRE-CARE to another parent of a preschool-age child · Disagree/Strongly Disagree
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
I would recommend PRE-CARE to another parent of a preschool-age child · Missing
|
0 Participants
|
—
|
|
PRE-CARE Feasibility and Acceptability Questionnaire
PRE-CARE was too short · Agree/Strongly Agree
|
7 Participants
|
—
|
Adverse Events
Intervention Group- PRE-CARE
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group- Care as Usual
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Andrea Spencer
Ann & Robert H. Lurie Children's Hospital of Chicago
Phone: 3122273402
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place