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| ID | Type | Description | Link |
|---|---|---|---|
| 5K23MH118478-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group- PRE-CARE | Experimental | 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. |
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| Control group- Care as Usual | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Screening | Other | Parent-report screening for remediable, unmet social needs. |
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| Measure | Description | Time Frame |
|---|---|---|
| ADHD Symptoms | 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. | Baseline, 3 months, 6 months, and 12 months |
| Total Resources Enrolled (Parent Report) | Resource 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. | Baseline, 3 months, 6 months, 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Child Psychiatric Symptoms | The 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. |
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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 affiliated 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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Spencer, MD | Ann & Robert H Lurie Children's Hospital of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ann & Robert H. Lurie Children's Hospital of Chicago | Chicago | Illinois | 60611 | United States | ||
| Boston Medical Center |
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We enrolled 54 parents but only 45 parents were ultimately randomized, hence the discrepancy between enrollment and participant flow.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 7, 2022 |
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| Resource Packet | Other | 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. |
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| Resource Navigation | Other | Navigation to resources, care coordination, and parent support provided by a trained bachelors-level interventionist. |
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| Care as usual | Other | Screening for social needs annually at well-child visits as recommended by the AAP followed by provision of information as needed by the family. |
|
| Baseline, 6 months, 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 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. | 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 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. | 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. 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. | 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 |
| Boston |
| Massachusetts |
| 02118 |
| United States |
| FG001 | 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. |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | ADHD Symptoms | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months, 6 months, and 12 months |
|
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| ||||||||||||||||||||||||||||||||||||
| Primary | Total Resources Enrolled (Parent Report) | Resource 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 3 months, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | Child Psychiatric Symptoms | The 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. | Posted | Mean | Standard Deviation | T-score | Baseline, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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 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. | Posted | Median | Inter-Quartile Range | score on a scale | baseline, 3 months, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. 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. | Posted | Mean | Standard Deviation | score on a scale | baseline, 3 months, 6 months, 12 months |
| ||||||||||||||||||||||||||||||||||||||
| Secondary | 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. | Reporting percent of participants who agreed or strongly disagreed with each item | Posted | Count of Participants | Participants | 3 months |
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Collected for 12 months after enrollment for each subject.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. | 0 | 22 | 0 | 22 | 0 | 22 |
| EG001 | 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. | 0 | 23 | 0 | 23 | 0 | 23 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrea Spencer | Ann & Robert H. Lurie Children's Hospital of Chicago | 3122273402 | aspencer@luriechildrens.org |
| Jul 2, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D008403 | Mass Screening |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006306 | Health Surveys |
| D011795 | Surveys and Questionnaires |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D015980 | Public Health Practice |
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| >=65 years |
|
| Male |
|
| Non-Hispanic Black |
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| Non-Hispanic White |
|
| More than one race |
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| Other race |
|
| 6 months |
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| 12 months |
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| OG001 | 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. |
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| OG001 | 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. |
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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. |
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| OG001 | 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. |
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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. |
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| Units | Counts |
|---|---|
| Participants |
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