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Communication to Improve Shared Decision-Making in ADHD

Communication to Improve Shared Decision-Making in Attention-Deficit/Hyperactivity Disorder

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02716324
Acronym
ADHD-Link
Enrollment
303
Registered
2016-03-23
Start date
2016-03-10
Completion date
2018-10-14
Last updated
2019-11-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

Attention-Deficit/Hyperactivity Disorder, Shared-Decision Making, Care Manager, Children, Parents, Teachers

Brief summary

The purpose of this study was to explore whether using an online patient portal plus a Care Manager is more effective than using an online portal alone in managing care for children with ADHD. Doctors at The Children's Hospital of Philadelphia currently use the online patient portal to help gather information from parents and teachers on ADHD symptoms, treatment, and medication side effects. The Care Manager is a person who meets with participants during the study to discuss their child's ADHD care. The Care Manager communicates with the child's doctor and teacher to communicate a parent's goals and preferences for their child's ADHD care.

Detailed description

Fragmentation in health care and poor communication across systems adversely impact engagement and adherence to treatment by children with ADHD and their families. Fragmentation of services for ADHD impairs communication and collaboration between families and primary care providers, mental health providers, and educators, and leads to suboptimal outcomes for children. Prior studies have documented that little communication and coordination exist among providers across different systems despite calls for better system integration. Fragmentation in communication between providers has the potential to impair shared decision-making. To promote shared decision-making, we developed an electronic health record (EHR)-linked portal to collect information from parents, teachers and clinicians on children's ADHD symptoms and treatment-related preferences and goals. This has become standard of care at our institution. We also developed and pilot tested a ADHD Care Manager intervention which will be employed in this comparative effectiveness study. 303 participants were recruited from 11 primary care pediatric practices. Participants were randomly assigned to either the EHR portal alone, or the EHR portal plus a Care Manager. For those assigned to the EHR portal plus Care Manager, the Care Manager met with families at the beginning of the study to confirm their treatment preferences and goals, provide additional education on ADHD treatment, and distribute handouts on common concerns among ADHD patients and families. The Care Manager contacted families every 3 months or more frequently if needed by phone, email, or in-person to assess treatment use, identify new concerns, and assist families with problem-solving. The Care Manager also communicated with primary care clinicians, mental health providers, and teachers to clarify family treatment preferences and goals and address emerging treatment issues. Participants completed surveys that assessed ADHD symptoms, goal attainment, patient-reported outcomes, patient and family engagement, and treatment initiation and adherence.

Interventions

BEHAVIORALCare Manager CM)

The CM was an individual responsible for communicating and coordinating ADHD care. The CM established rapport with families and communicated with them every 3 months or more frequently if needed to assess treatment use, identify new concerns, and help problem-solve. The CM also communicated with the patient's ADHD care team (pediatrician, teacher, mental health providers) to clarify family goals, communicate information, and coordinate treatment.

OTHERADHD Portal

The ADHD portal was a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment were measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents were encouraged to consult with their children when completing the tool.

Sponsors

Patient-Centered Outcomes Research Institute
CollaboratorOTHER
Children's Hospital of Philadelphia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
5 Years to 12 Years
Healthy volunteers
No

Inclusion criteria

* Aged 5 through12 years old * Receiving Attention-Deficit/Hyperactivity Disorder (ADHD) treatment from participating practices * ADHD or Attention Deficit Disorder (ADD) diagnosis code, International Classification of Diseases (ICD) code ICD-10-CM F90.9 or F90.0, listed in the problem list or recorded at an ambulatory visit in the past year. * Parental/guardian permission (informed consent) and if appropriate, child assent.

Exclusion criteria

* Autism spectrum disorder, ICD-10-CM F84.0 * Conduct disorder, ICD-10-CM F91.1 * Psychosis, ICD-10-CM F29 * Bipolar disorder, ICD-10-CM F31.9 * Suicide attempt, ICD-10-CM T14.91, or suicide ideation, ICD-10-CM R45.85 * Children and/or their parents/caregivers non-English speaking

Design outcomes

Primary

MeasureTime frameDescription
Change in Vanderbilt Parent Rating Scales (VPRS)Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating (never to very often), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating (never to very often). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.

Secondary

MeasureTime frameDescription
Treatment Initiation and Use of Services9-12 months (Visit 4)Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
Treatment Adherence and Use of Services9-12 months (Visit 4)Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.
School PerformanceBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Student EngagementBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Mean Goal Attainment Scale (GAS) Score by TimepointBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 (no change) to 6 (goal completely met). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Peer RelationshipsBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Family RelationshipsBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.
Engagement Measure ScoresVisit 4 (9-12 months)The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.
Teacher ConnectednessBaseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Countries

United States

Participant flow

Recruitment details

From 3/2016-7/2017, primary care clinicians at participating pediatric practices nominated eligible patients for recruitment. Eligible patients were contacted by phone and then underwent in-person informed consent. Participants were stratified by practice, age group (5-7 or 8-12 years old), and sex and randomized 1:1 to the two study arms.

Pre-assignment details

Eligible participants were excluded prior to enrollment if they had history of suicide, bipolar disorder, schizophrenia, autism, or conduct disorder.

Participants by arm

ArmCount
ADHD Portal
In this arm, the ADHD Portal will be used alone as an electronic communication tool.The ADHD portal is considered standard of care at our institution for communicating information between clinicians, teachers, and parents. ADHD Portal: The ADHD portal is a web-based platform that permits access to parts of the hospital's electronic health record. The portal permits (1) capture and sharing of patient and family treatment preferences and goals, (2) monitoring of ADHD symptoms, treatment receipt, and side effects, and (3) assessing goal attainment. The system prompts for completion of periodic check-in surveys (bi-weekly to 3 months) with parents and teachers. Within the portal, preferences and goals for ADHD treatment are measured using the ADHD Preference Goal Instrument (PGI) (Fiks et al., 2012). Parents are encouraged to consult with their children when completing the tool.
149
ADHD Portal Plus Care Manager
In this arm, the ADHD Portal is combined with the Care Manager. Clinicians, teachers, and parents will use the ADHD Portal. Clinicians, teachers, parents, and any external mental health providers will interact with a Care Manager, who will have access to information contained in the ADHD Portal. Care Manager: The CM is responsible for communicating and coordinating ADHD care. The CM communicates with families weekly-every 3 months to assess treatment use and concerns, and problem-solve. The CM communicates with their ADHD care team (pediatrician, teacher, mental health provider) to clarify goals, communicate information, and coordinate treatment. ADHD Portal: The ADHD portal is a web platform that permits access to parts of CHOP's electronic health record. The portal permits 1) capture, sharing of treatment preferences. 2) monitoring of ADHD symptoms, treatments, and side effects, and 3) assessing goal attainment.
154
Total303

Baseline characteristics

CharacteristicADHD PortalADHD Portal Plus Care ManagerTotal
Age, Categorical
<=18 years
149 Participants154 Participants303 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Baseline Vanderbilt Parent Rating Scale Scores32.6 Vanderbilt Parent Rating Scale Score
STANDARD_DEVIATION 11.8
31.3 Vanderbilt Parent Rating Scale Score
STANDARD_DEVIATION 10.8
31.9 Vanderbilt Parent Rating Scale Score
STANDARD_DEVIATION 11.3
Race/Ethnicity, Customized
Race/Ethnicity
Black/African American
69 Participants70 Participants139 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Hispanic
7 Participants8 Participants15 Participants
Race/Ethnicity, Customized
Race/Ethnicity
Other
15 Participants13 Participants28 Participants
Race/Ethnicity, Customized
Race/Ethnicity
White
58 Participants62 Participants120 Participants
Region of Enrollment
United States
149 participants154 participants303 participants
Sex: Female, Male
Female
47 Participants47 Participants94 Participants
Sex: Female, Male
Male
102 Participants106 Participants208 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1490 / 154
other
Total, other adverse events
0 / 1490 / 154
serious
Total, serious adverse events
0 / 1490 / 154

Outcome results

Primary

Change in Vanderbilt Parent Rating Scales (VPRS)

The VPRS is a public domain tool that consists of forms completed by the child's parent and includes 18 items corresponding to the DSM-5 ADHD symptom criteria, 8 performance items, and 12 items assessing side effects. The VPRS items are scaled on a 4-point Likert rating (never to very often), and the scales used in this study were restricted to the 18 ADHD symptom items. Total scores were used to measure ADHD Symptoms. Higher scores indicated worse outcome. VPRS were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value. The VPRS measures ADHD symptoms and is scaled on a 4-point Likert rating (never to very often). The scale includes 18 ADHD symptom items with total scores ranges from 0-54.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row differs from the overall number due to missing data.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalChange in Vanderbilt Parent Rating Scales (VPRS)Visit 132.6 score on a scaleStandard Deviation 11.8
ADHD PortalChange in Vanderbilt Parent Rating Scales (VPRS)Visit 228.7 score on a scaleStandard Deviation 12.2
ADHD PortalChange in Vanderbilt Parent Rating Scales (VPRS)Visit 328.1 score on a scaleStandard Deviation 12.1
ADHD PortalChange in Vanderbilt Parent Rating Scales (VPRS)Visit 427.2 score on a scaleStandard Deviation 12.1
ADHD Portal Plus Care ManagerChange in Vanderbilt Parent Rating Scales (VPRS)Visit 425.7 score on a scaleStandard Deviation 11.1
ADHD Portal Plus Care ManagerChange in Vanderbilt Parent Rating Scales (VPRS)Visit 131.3 score on a scaleStandard Deviation 10.8
ADHD Portal Plus Care ManagerChange in Vanderbilt Parent Rating Scales (VPRS)Visit 326.3 score on a scaleStandard Deviation 11.6
ADHD Portal Plus Care ManagerChange in Vanderbilt Parent Rating Scales (VPRS)Visit 229.0 score on a scaleStandard Deviation 11.4
Comparison: Random effects models regressed VPRS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.p-value: 0.87195% CI: [-0.01, 0.012]GLS random-effects model
Secondary

Engagement Measure Scores

The Engagement Measure is a 28-item parent self-report measure comprised of four domains: Access (5-items, total score range 5-25), Patient Family Centered Care or PFCC (6-items, total score range 6-30), Communication (3-items, total score range 3-15), and Understanding (5-items, total score range 5-25). Total scores are not reported below. Scores for each individual item and therefore the mean for each domain (means reported in the table below) ranged from 1-5 with higher scores indicating greater engagement. The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Visit 4 (9-12 months)

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalEngagement Measure ScoresCommunication2.50 Score on a scaleStandard Deviation 1.1
ADHD PortalEngagement Measure ScoresAccess3.43 Score on a scaleStandard Deviation 0.7
ADHD PortalEngagement Measure ScoresUnderstanding2.89 Score on a scaleStandard Deviation 0.8
ADHD PortalEngagement Measure ScoresPFCC3.45 Score on a scaleStandard Deviation 0.7
ADHD Portal Plus Care ManagerEngagement Measure ScoresUnderstanding3.02 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerEngagement Measure ScoresAccess3.52 Score on a scaleStandard Deviation 0.6
ADHD Portal Plus Care ManagerEngagement Measure ScoresCommunication2.64 Score on a scaleStandard Deviation 1
ADHD Portal Plus Care ManagerEngagement Measure ScoresPFCC3.44 Score on a scaleStandard Deviation 0.7
Comparison: Random effects models regressed Access Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.p-value: 0.49595% CI: [-0.164, 0.311]Random effects model
Comparison: Random effects models regressed Patient Family Centered Care Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.p-value: 0.88595% CI: [-0.217, 0.191]Random effects model
Comparison: Random effects models regressed Communication Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.p-value: 0.52795% CI: [-0.182, 0.328]Random effects model
Comparison: Random effects models regressed Understanding Engagement Scores Scores on intervention status adjusted for season and clustered by doctor's office.p-value: 0.28595% CI: [-0.138, 0.41]Random effects model
Secondary

Family Relationships

Family Relationships is a 6-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 30-item Child- (age 8-12) Patient Reported Outcomes Measures of relationships with other family members over the past 4 weeks. The minimum total score for the Family Relationships domain is 6 and the maximum total score is 30 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Family Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row values may differ from overall number for analysis due to missing data.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalFamily RelationshipsChild PROS : Visit 13.81 Score on a scaleStandard Deviation 0.77
ADHD PortalFamily RelationshipsChild PROS : Visit 23.83 Score on a scaleStandard Deviation 0.69
ADHD PortalFamily RelationshipsChild PROS : Visit 33.96 Score on a scaleStandard Deviation 0.67
ADHD PortalFamily RelationshipsChild PROS : Visit 43.81 Score on a scaleStandard Deviation 0.77
ADHD Portal Plus Care ManagerFamily RelationshipsChild PROS : Visit 43.79 Score on a scaleStandard Deviation 76
ADHD Portal Plus Care ManagerFamily RelationshipsChild PROS : Visit 13.82 Score on a scaleStandard Deviation 0.68
ADHD Portal Plus Care ManagerFamily RelationshipsChild PROS : Visit 33.72 Score on a scaleStandard Deviation 0.72
ADHD Portal Plus Care ManagerFamily RelationshipsChild PROS : Visit 23.80 Score on a scaleStandard Deviation 0.65
Comparison: Random effects models regressed Child-reported PRO Family Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.67995% CI: [-0.001, 0.001]Random effects model
Secondary

Mean Goal Attainment Scale (GAS) Score by Timepoint

The GAS is a 5-point likert scale that assesses the degree to which parents' goals (obtained from the ADHD Preferences and Goals Instrument) are attained from none to completely. The GAS response categories are ordered from 0 (no change) to 6 (goal completely met). Higher scores indicate greater goal attainment. The GAS was measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalMean Goal Attainment Scale (GAS) Score by TimepointVisit 22.92 Units on a scaleStandard Deviation 1.82
ADHD PortalMean Goal Attainment Scale (GAS) Score by TimepointVisit 32.93 Units on a scaleStandard Deviation 1.89
ADHD PortalMean Goal Attainment Scale (GAS) Score by TimepointVisit 43.03 Units on a scaleStandard Deviation 1.66
ADHD Portal Plus Care ManagerMean Goal Attainment Scale (GAS) Score by TimepointVisit 22.67 Units on a scaleStandard Deviation 1.68
ADHD Portal Plus Care ManagerMean Goal Attainment Scale (GAS) Score by TimepointVisit 33.01 Units on a scaleStandard Deviation 1.68
ADHD Portal Plus Care ManagerMean Goal Attainment Scale (GAS) Score by TimepointVisit 42.86 Units on a scaleStandard Deviation 1.75
Comparison: Random effects models regressed GAS scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. We examined intervention X time interaction term for statistical significance.p-value: 0.49995% CI: [-0.002, 0.004]Random effects model
Secondary

Peer Relationships

Peer Relationships is a 6-item domain (minimum=1, maximum=5, on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and a 7-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score is 6 and the maximum total score is 30 on the Child PROs. The minimum total score for the Peer Relationships domain is 7 and the maximum total score is 35 on the Parent PROs. Total scores not shown below. Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Higher scores indicate better outcomes. Peer Relationships PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalPeer RelationshipsParent PROS : Visit 13.56 Score on a scaleStandard Deviation 0.82
ADHD PortalPeer RelationshipsParent PROS : Visit 23.63 Score on a scaleStandard Deviation 0.75
ADHD PortalPeer RelationshipsParent PROS : Visit 33.61 Score on a scaleStandard Deviation 0.79
ADHD PortalPeer RelationshipsParent PROS : Visit 43.72 Score on a scaleStandard Deviation 0.8
ADHD PortalPeer RelationshipsChild PROS : Visit 14.03 Score on a scaleStandard Deviation 0.74
ADHD PortalPeer RelationshipsChild PROS : Visit 23.79 Score on a scaleStandard Deviation 0.75
ADHD PortalPeer RelationshipsChild PROS : Visit 33.84 Score on a scaleStandard Deviation 0.74
ADHD PortalPeer RelationshipsChild PROS : Visit 43.91 Score on a scaleStandard Deviation 0.83
ADHD Portal Plus Care ManagerPeer RelationshipsChild PROS : Visit 43.94 Score on a scaleStandard Deviation 0.79
ADHD Portal Plus Care ManagerPeer RelationshipsParent PROS : Visit 13.54 Score on a scaleStandard Deviation 0.74
ADHD Portal Plus Care ManagerPeer RelationshipsChild PROS : Visit 14.07 Score on a scaleStandard Deviation 0.71
ADHD Portal Plus Care ManagerPeer RelationshipsParent PROS : Visit 23.56 Score on a scaleStandard Deviation 0.75
ADHD Portal Plus Care ManagerPeer RelationshipsChild PROS : Visit 33.99 Score on a scaleStandard Deviation 0.72
ADHD Portal Plus Care ManagerPeer RelationshipsParent PROS : Visit 33.63 Score on a scaleStandard Deviation 0.74
ADHD Portal Plus Care ManagerPeer RelationshipsChild PROS : Visit 23.93 Score on a scaleStandard Deviation 0.84
ADHD Portal Plus Care ManagerPeer RelationshipsParent PROS : Visit 43.66 Score on a scaleStandard Deviation 0.72
Comparison: Random effects models regressed Parent-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.87395% CI: [-0.001, 0.001]Random effects model
Comparison: Random effects models regressed Child-reported PRO Peer Relationship Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.88895% CI: [-0.001, 0.001]Random effects model
Secondary

School Performance

School Performance is a 5-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the School Performance domain is 5 and the maximum total score is 25 (total scores are not shown below). Values in the table below are reported as mean scores at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. School performance PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalSchool PerformanceParent PROS : Visit 43.08 Score on a scaleStandard Deviation 0.96
ADHD PortalSchool PerformanceParent PROS : Visit 12.82 Score on a scaleStandard Deviation 1
ADHD PortalSchool PerformanceParent PROS : Visit 23.00 Score on a scaleStandard Deviation 1.01
ADHD PortalSchool PerformanceParent PROS : Visit 33.03 Score on a scaleStandard Deviation 0.89
ADHD PortalSchool PerformanceChild PROS : Visit 13.53 Score on a scaleStandard Deviation 0.77
ADHD PortalSchool PerformanceChild PROS : Visit 23.22 Score on a scaleStandard Deviation 0.93
ADHD PortalSchool PerformanceChild PROS : Visit 33.29 Score on a scaleStandard Deviation 0.85
ADHD PortalSchool PerformanceChild PROS : Visit 43.23 Score on a scaleStandard Deviation 0.83
ADHD Portal Plus Care ManagerSchool PerformanceChild PROS : Visit 43.41 Score on a scaleStandard Deviation 0.86
ADHD Portal Plus Care ManagerSchool PerformanceParent PROS : Visit 33.04 Score on a scaleStandard Deviation 0.92
ADHD Portal Plus Care ManagerSchool PerformanceChild PROS : Visit 13.42 Score on a scaleStandard Deviation 0.79
ADHD Portal Plus Care ManagerSchool PerformanceParent PROS : Visit 12.77 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerSchool PerformanceChild PROS : Visit 33.27 Score on a scaleStandard Deviation 0.77
ADHD Portal Plus Care ManagerSchool PerformanceParent PROS : Visit 22.91 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerSchool PerformanceChild PROS : Visit 23.30 Score on a scaleStandard Deviation 0.81
ADHD Portal Plus Care ManagerSchool PerformanceParent PROS : Visit 43.03 Score on a scaleStandard Deviation 0.9
Comparison: Random effects models regressed Parent-reported PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.66295% CI: [-0.001, 0.001]Random effects model
Comparison: Random effects models regressed Child PRO School Performance Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.07595% CI: [0, 0.002]Random effects model
Secondary

Student Engagement

Student Engagement is a 4-item domain (minimum score=1, maximum score=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Student Engagement domain is 4 and the maximum total score is 20 (total scores are not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Student Engagement PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row values may differ from overall values due to missing data and due to child measures being completed only by children 8-12 years old.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalStudent EngagementParent PROS : Visit 12.98 Score on a scaleStandard Deviation 0.79
ADHD PortalStudent EngagementParent PROS : Visit 23.18 Score on a scaleStandard Deviation 0.85
ADHD PortalStudent EngagementParent PROS : Visit 33.18 Score on a scaleStandard Deviation 0.78
ADHD PortalStudent EngagementParent PROS : Visit 43.24 Score on a scaleStandard Deviation 0.82
ADHD PortalStudent EngagementChild PROS : Visit 13.11 Score on a scaleStandard Deviation 0.82
ADHD PortalStudent EngagementChild PROS : Visit 23.09 Score on a scaleStandard Deviation 0.09
ADHD PortalStudent EngagementChild PROS : Visit 33.15 Score on a scaleStandard Deviation 0.94
ADHD PortalStudent EngagementChild PROS : Visit 43.08 Score on a scaleStandard Deviation 0.83
ADHD Portal Plus Care ManagerStudent EngagementChild PROS : Visit 42.95 Score on a scaleStandard Deviation 0.79
ADHD Portal Plus Care ManagerStudent EngagementParent PROS : Visit 12.93 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerStudent EngagementChild PROS : Visit 13.04 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerStudent EngagementParent PROS : Visit 23.08 Score on a scaleStandard Deviation 0.8
ADHD Portal Plus Care ManagerStudent EngagementChild PROS : Visit 33.01 Score on a scaleStandard Deviation 0.78
ADHD Portal Plus Care ManagerStudent EngagementParent PROS : Visit 33.09 Score on a scaleStandard Deviation 0.7
ADHD Portal Plus Care ManagerStudent EngagementChild PROS : Visit 23.06 Score on a scaleStandard Deviation 0.73
ADHD Portal Plus Care ManagerStudent EngagementParent PROS : Visit 43.13 Score on a scaleStandard Deviation 0.8
Comparison: Random effects models regressed Parent-reported PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.70795% CI: [-0.001, 0.001]Random effects model
Comparison: Random effects models regressed Child PRO Student Engagement Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.73595% CI: [-0.001, 0.001]Random effects model
Secondary

Teacher Connectedness

Teacher Connectedness is a 9-item domain (minimum=1, maximum=5 on a 5 point Likert scale) of the of 30-item Child- (age 8-12) and 17-item Parent Patient Reported Outcomes Scores (PROS). The minimum total score for the Teacher Connectedness domain is 9 and the maximum total score is 45 (total scores not shown below). Values in the table below are reported as means at each time point and therefore fall between the minimum score of 1 and maximum score of 5. Higher scores indicate better outcomes. Parent-reported PRO and child-reported PRO measures were averaged for each domain for each time point. Teacher Connectedness PRO scores were measured at baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4). The time range given for Visit 4 reflects the time range counted as a single value.

Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)

Population: Row values may differ from overall number analyzed due to missing data.

ArmMeasureGroupValue (MEAN)Dispersion
ADHD PortalTeacher ConnectednessChild PROS : Visit 43.75 Score on a scaleStandard Error 0.87
ADHD PortalTeacher ConnectednessChild PROS : Visit 33.86 Score on a scaleStandard Error 0.86
ADHD PortalTeacher ConnectednessChild PROS : Visit 23.85 Score on a scaleStandard Error 0.76
ADHD PortalTeacher ConnectednessChild PROS : Visit 13.81 Score on a scaleStandard Error 0.8
ADHD Portal Plus Care ManagerTeacher ConnectednessChild PROS : Visit 43.72 Score on a scaleStandard Error 0.84
ADHD Portal Plus Care ManagerTeacher ConnectednessChild PROS : Visit 13.75 Score on a scaleStandard Error 0.76
ADHD Portal Plus Care ManagerTeacher ConnectednessChild PROS : Visit 23.82 Score on a scaleStandard Error 0.77
ADHD Portal Plus Care ManagerTeacher ConnectednessChild PROS : Visit 33.77 Score on a scaleStandard Error 0.83
Comparison: Random effects models regressed Child PRO Teacher Connectedness Scores on intervention status, time (days), intervention by time, season, and clustered by doctor's office. we examined intervention X time interaction term for statistical significance.p-value: 0.73595% CI: [-0.001, 0.001]Random effects model
Secondary

Treatment Adherence and Use of Services

Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment adherence was measured by use of services in the past nine months. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.

Time frame: 9-12 months (Visit 4)

Population: Rows may differ from overall umber analyzed due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA).

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
ADHD PortalTreatment Adherence and Use of ServicesUse of any service (Past 9 months)Yes48 Participants
ADHD PortalTreatment Adherence and Use of ServicesUse of any service (Past 9 months)No19 Participants
ADHD PortalTreatment Adherence and Use of ServicesUse of ambulatory services (Past 9 months)Yes47 Participants
ADHD PortalTreatment Adherence and Use of ServicesUse of ambulatory services (Past 9 months)No18 Participants
ADHD PortalTreatment Adherence and Use of ServicesOvernight Stay for Services (Ever)Yes1 Participants
ADHD PortalTreatment Adherence and Use of ServicesOvernight Stay for Services (Ever)No3 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesOvernight Stay for Services (Ever)Yes2 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesUse of any service (Past 9 months)Yes51 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesUse of ambulatory services (Past 9 months)No29 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesUse of any service (Past 9 months)No29 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesOvernight Stay for Services (Ever)No4 Participants
ADHD Portal Plus Care ManagerTreatment Adherence and Use of ServicesUse of ambulatory services (Past 9 months)Yes50 Participants
Comparison: Differences in proportions between the two groups in use of any mental health services during the study period were assessed using the Chi-square Test.p-value: 0.31Chi-squared
Comparison: Differences in proportions between the two groups in use of ambulatory mental health services during the study period were assessed using the Chi-square Test.p-value: 0.251Chi-squared
Comparison: Differences in proportions between the two groups in use of inpatient mental health services during the study period were assessed using the Chi-square Test.p-value: 1Chi-squared
Secondary

Treatment Initiation and Use of Services

Using responses from the Services Assessment for Children and Adolescents (SACA), a well-validated client-reported tool and provides information on any mental health services use, ambulatory services use, and inpatient service use, we determined (yes/no) whether participants ever received educational services, mental health services, or medications for ADHD. Parents reported whether their children used services ever or within the last nine months. Treatment initiation was measured by use of services ever. Categorizations include any service use, ambulatory service use (any community mental health or outpatient clinic, private professional, or in-home provider), and overnight stay (psychiatric or medical unit, residential treatment center, group home, or foster home). The time range of 9-12 given for Visit 4 reflects the time range counted as a single value.

Time frame: 9-12 months (Visit 4)

Population: Numbers may not add to column totals due to missing data. Values and percentages for Ambulatory and Overnight services do not add up to the over n listed for the column due to missing data and logic structure of the Service Assessment for Children and Adolescents (SACA).

ArmMeasureGroupCategoryValue (COUNT_OF_PARTICIPANTS)
ADHD PortalTreatment Initiation and Use of ServicesUse of ambulatory services (Ever) : YesYes77 Participants
ADHD PortalTreatment Initiation and Use of ServicesUse of any services (Ever) : YesYes79 Participants
ADHD PortalTreatment Initiation and Use of ServicesOvernight Stay for Services (Ever) : YesYes5 Participants
ADHD PortalTreatment Initiation and Use of ServicesUse of ambulatory services (Ever) : YesNo42 Participants
ADHD PortalTreatment Initiation and Use of ServicesOvernight Stay for Services (Ever) : YesNo92 Participants
ADHD PortalTreatment Initiation and Use of ServicesUse of any services (Ever) : YesNo40 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesOvernight Stay for Services (Ever) : YesNo118 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesUse of ambulatory services (Ever) : YesNo49 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesUse of any services (Ever) : YesYes88 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesUse of ambulatory services (Ever) : YesYes87 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesOvernight Stay for Services (Ever) : YesYes6 Participants
ADHD Portal Plus Care ManagerTreatment Initiation and Use of ServicesUse of any services (Ever) : YesNo49 Participants
Comparison: Differences in proportions between the two groups in use of any services were assessed using the Chi-square Test.p-value: 0.718Chi-squared
Comparison: Differences in proportions between the two groups in use of ambulatory mental health services were assessed using the Chi-square Test.p-value: 0.903Chi-squared
Comparison: Differences in proportions between the two groups in use of any inpatient mental health services were assessed using the Chi-square Test.p-value: 0.915Chi-squared

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026