Trial Outcomes & Findings for Communication to Improve Shared Decision-Making in ADHD (NCT NCT02716324)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

303 participants

Primary outcome timeframe

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

Results posted on

2019-11-25

Participant Flow

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.

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

Participant milestones

Participant milestones
Measure	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.	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.
Overall Study STARTED	149	154
Overall Study COMPLETED	130	143
Overall Study NOT COMPLETED	19	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Participants were recruited between ages five to twelve years old.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ADHD Portal n=149 Participants 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.	ADHD Portal Plus Care Manager n=154 Participants 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.	Total n=303 Participants Total of all reporting groups
Age, Categorical <=18 years	149 Participants n=149 Participants • Participants were recruited between ages five to twelve years old.	154 Participants n=154 Participants • Participants were recruited between ages five to twelve years old.	303 Participants n=303 Participants • Participants were recruited between ages five to twelve years old.
Age, Categorical Between 18 and 65 years	0 Participants n=149 Participants • Participants were recruited between ages five to twelve years old.	0 Participants n=154 Participants • Participants were recruited between ages five to twelve years old.	0 Participants n=303 Participants • Participants were recruited between ages five to twelve years old.
Age, Categorical >=65 years	0 Participants n=149 Participants • Participants were recruited between ages five to twelve years old.	0 Participants n=154 Participants • Participants were recruited between ages five to twelve years old.	0 Participants n=303 Participants • Participants were recruited between ages five to twelve years old.
Sex: Female, Male Female	47 Participants n=149 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	47 Participants n=153 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	94 Participants n=302 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Sex: Female, Male Male	102 Participants n=149 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	106 Participants n=153 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	208 Participants n=302 Participants • It was expected that the gender distribution would reflect the gender distribution of children with ADHD in the CHOP Care Network: 72% male, 28% female. The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Race/Ethnicity, Customized Race/Ethnicity · White	58 Participants n=149 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	62 Participants n=153 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	120 Participants n=302 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Race/Ethnicity, Customized Race/Ethnicity · Black/African American	69 Participants n=149 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	70 Participants n=153 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	139 Participants n=302 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Race/Ethnicity, Customized Race/Ethnicity · Hispanic	7 Participants n=149 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	8 Participants n=153 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	15 Participants n=302 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Race/Ethnicity, Customized Race/Ethnicity · Other	15 Participants n=149 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	13 Participants n=153 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.	28 Participants n=302 Participants • The row population differs from the overall by one as a participant did not complete further measures after consenting to the study and being randomized to the ADHD Portal Plus Care Manager Arm.
Region of Enrollment United States	149 participants n=149 Participants	154 participants n=154 Participants	303 participants n=303 Participants
Baseline Vanderbilt Parent Rating Scale Scores	32.6 Vanderbilt Parent Rating Scale Score STANDARD_DEVIATION 11.8 • n=148 Participants • 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. Row differs from overall because of missing data.	31.3 Vanderbilt Parent Rating Scale Score STANDARD_DEVIATION 10.8 • n=152 Participants • 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. Row differs from overall because of missing data.	31.9 Vanderbilt Parent Rating Scale Score STANDARD_DEVIATION 11.3 • n=300 Participants • 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. Row differs from overall because of missing data.

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=149 Participants 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.	ADHD Portal Plus Care Manager n=154 Participants 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.
Change in Vanderbilt Parent Rating Scales (VPRS) Visit 1	32.6 score on a scale Standard Deviation 11.8	31.3 score on a scale Standard Deviation 10.8
Change in Vanderbilt Parent Rating Scales (VPRS) Visit 2	28.7 score on a scale Standard Deviation 12.2	29.0 score on a scale Standard Deviation 11.4
Change in Vanderbilt Parent Rating Scales (VPRS) Visit 3	28.1 score on a scale Standard Deviation 12.1	26.3 score on a scale Standard Deviation 11.6
Change in Vanderbilt Parent Rating Scales (VPRS) Visit 4	27.2 score on a scale Standard Deviation 12.1	25.7 score on a scale Standard Deviation 11.1

SECONDARY outcome

Timeframe: Baseline (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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=114 Participants 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.	ADHD Portal Plus Care Manager n=127 Participants 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.
Mean Goal Attainment Scale (GAS) Score by Timepoint Visit 2	2.92 Units on a scale Standard Deviation 1.82	2.67 Units on a scale Standard Deviation 1.68
Mean Goal Attainment Scale (GAS) Score by Timepoint Visit 3	2.93 Units on a scale Standard Deviation 1.89	3.01 Units on a scale Standard Deviation 1.68
Mean Goal Attainment Scale (GAS) Score by Timepoint Visit 4	3.03 Units on a scale Standard Deviation 1.66	2.86 Units on a scale Standard Deviation 1.75

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=119 Participants 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.	ADHD Portal Plus Care Manager n=137 Participants 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.
Treatment Initiation and Use of Services Use of any services (Ever) : Yes · Yes	79 Participants	88 Participants
Treatment Initiation and Use of Services Use of any services (Ever) : Yes · No	40 Participants	49 Participants
Treatment Initiation and Use of Services Use of ambulatory services (Ever) : Yes · Yes	77 Participants	87 Participants
Treatment Initiation and Use of Services Use of ambulatory services (Ever) : Yes · No	42 Participants	49 Participants
Treatment Initiation and Use of Services Overnight Stay for Services (Ever) : Yes · Yes	5 Participants	6 Participants
Treatment Initiation and Use of Services Overnight Stay for Services (Ever) : Yes · No	92 Participants	118 Participants

SECONDARY outcome

Timeframe: 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).

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=67 Participants 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.	ADHD Portal Plus Care Manager n=80 Participants 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.
Treatment Adherence and Use of Services Use of any service (Past 9 months) · Yes	48 Participants	51 Participants
Treatment Adherence and Use of Services Use of any service (Past 9 months) · No	19 Participants	29 Participants
Treatment Adherence and Use of Services Use of ambulatory services (Past 9 months) · Yes	47 Participants	50 Participants
Treatment Adherence and Use of Services Use of ambulatory services (Past 9 months) · No	18 Participants	29 Participants
Treatment Adherence and Use of Services Overnight Stay for Services (Ever) · Yes	1 Participants	2 Participants
Treatment Adherence and Use of Services Overnight Stay for Services (Ever) · No	3 Participants	4 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=148 Participants 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.	ADHD Portal Plus Care Manager n=150 Participants 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.
School Performance Parent PROS : Visit 1	2.82 Score on a scale Standard Deviation 1.00	2.77 Score on a scale Standard Deviation 0.80
School Performance Parent PROS : Visit 2	3.00 Score on a scale Standard Deviation 1.01	2.91 Score on a scale Standard Deviation 0.80
School Performance Parent PROS : Visit 3	3.03 Score on a scale Standard Deviation 0.89	3.04 Score on a scale Standard Deviation 0.92
School Performance Parent PROS : Visit 4	3.08 Score on a scale Standard Deviation 0.96	3.03 Score on a scale Standard Deviation 0.90
School Performance Child PROS : Visit 1	3.53 Score on a scale Standard Deviation 0.77	3.42 Score on a scale Standard Deviation 0.79
School Performance Child PROS : Visit 2	3.22 Score on a scale Standard Deviation 0.93	3.30 Score on a scale Standard Deviation 0.81
School Performance Child PROS : Visit 3	3.29 Score on a scale Standard Deviation 0.85	3.27 Score on a scale Standard Deviation 0.77
School Performance Child PROS : Visit 4	3.23 Score on a scale Standard Deviation 0.83	3.41 Score on a scale Standard Deviation 0.86

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=148 Participants 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.	ADHD Portal Plus Care Manager n=152 Participants 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.
Student Engagement Child PROS : Visit 2	3.09 Score on a scale Standard Deviation 0.09	3.06 Score on a scale Standard Deviation 0.73
Student Engagement Child PROS : Visit 3	3.15 Score on a scale Standard Deviation 0.94	3.01 Score on a scale Standard Deviation 0.78
Student Engagement Child PROS : Visit 4	3.08 Score on a scale Standard Deviation 0.83	2.95 Score on a scale Standard Deviation 0.79
Student Engagement Parent PROS : Visit 1	2.98 Score on a scale Standard Deviation 0.79	2.93 Score on a scale Standard Deviation 0.80
Student Engagement Parent PROS : Visit 2	3.18 Score on a scale Standard Deviation 0.85	3.08 Score on a scale Standard Deviation 0.80
Student Engagement Parent PROS : Visit 3	3.18 Score on a scale Standard Deviation 0.78	3.09 Score on a scale Standard Deviation 0.70
Student Engagement Parent PROS : Visit 4	3.24 Score on a scale Standard Deviation 0.82	3.13 Score on a scale Standard Deviation 0.80
Student Engagement Child PROS : Visit 1	3.11 Score on a scale Standard Deviation 0.82	3.04 Score on a scale Standard Deviation 0.80

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=120 Participants 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.	ADHD Portal Plus Care Manager n=121 Participants 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.
Teacher Connectedness Child PROS : Visit 1	3.81 Score on a scale Standard Error 0.80	3.75 Score on a scale Standard Error 0.76
Teacher Connectedness Child PROS : Visit 2	3.85 Score on a scale Standard Error 0.76	3.82 Score on a scale Standard Error 0.77
Teacher Connectedness Child PROS : Visit 3	3.86 Score on a scale Standard Error 0.86	3.77 Score on a scale Standard Error 0.83
Teacher Connectedness Child PROS : Visit 4	3.75 Score on a scale Standard Error 0.87	3.72 Score on a scale Standard Error 0.84

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=148 Participants 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.	ADHD Portal Plus Care Manager n=152 Participants 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.
Peer Relationships Parent PROS : Visit 1	3.56 Score on a scale Standard Deviation 0.82	3.54 Score on a scale Standard Deviation 0.74
Peer Relationships Parent PROS : Visit 2	3.63 Score on a scale Standard Deviation 0.75	3.56 Score on a scale Standard Deviation 0.75
Peer Relationships Parent PROS : Visit 3	3.61 Score on a scale Standard Deviation 0.79	3.63 Score on a scale Standard Deviation 0.74
Peer Relationships Parent PROS : Visit 4	3.72 Score on a scale Standard Deviation 0.80	3.66 Score on a scale Standard Deviation 0.72
Peer Relationships Child PROS : Visit 1	4.03 Score on a scale Standard Deviation 0.74	4.07 Score on a scale Standard Deviation 0.71
Peer Relationships Child PROS : Visit 2	3.79 Score on a scale Standard Deviation 0.75	3.93 Score on a scale Standard Deviation 0.84
Peer Relationships Child PROS : Visit 3	3.84 Score on a scale Standard Deviation 0.74	3.99 Score on a scale Standard Deviation 0.72
Peer Relationships Child PROS : Visit 4	3.91 Score on a scale Standard Deviation 0.83	3.94 Score on a scale Standard Deviation 0.79

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=120 Participants 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.	ADHD Portal Plus Care Manager n=121 Participants 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.
Family Relationships Child PROS : Visit 1	3.81 Score on a scale Standard Deviation 0.77	3.82 Score on a scale Standard Deviation 0.68
Family Relationships Child PROS : Visit 2	3.83 Score on a scale Standard Deviation 0.69	3.80 Score on a scale Standard Deviation 0.65
Family Relationships Child PROS : Visit 3	3.96 Score on a scale Standard Deviation 0.67	3.72 Score on a scale Standard Deviation 0.72
Family Relationships Child PROS : Visit 4	3.81 Score on a scale Standard Deviation 0.77	3.79 Score on a scale Standard Deviation 076

SECONDARY outcome

Timeframe: Visit 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.

Outcome measures

Outcome measures
Measure	ADHD Portal n=123 Participants 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.	ADHD Portal Plus Care Manager n=139 Participants 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.
Engagement Measure Scores Access	3.43 Score on a scale Standard Deviation 0.7	3.52 Score on a scale Standard Deviation 0.6
Engagement Measure Scores PFCC	3.45 Score on a scale Standard Deviation 0.7	3.44 Score on a scale Standard Deviation 0.7
Engagement Measure Scores Communication	2.50 Score on a scale Standard Deviation 1.1	2.64 Score on a scale Standard Deviation 1.0
Engagement Measure Scores Understanding	2.89 Score on a scale Standard Deviation 0.8	3.02 Score on a scale Standard Deviation 0.8

Adverse Events

ADHD Portal

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

ADHD Portal Plus Care Manager

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

James Guevara, MD MPH

The Children's Hospital of Philadelphia

Phone: 2155901130

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place