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NCT02716324: ADHD-Link

Communication to Improve Shared Decision-Making in ADHD

Completed NA Results posted Last updated 25 November 2019
What this trial tests

NA trial testing Care Manager CM) in Attention-Deficit/Hyperactivity Disorder in 303 participants. Completed in 14 October 2018.

Timeline
10 March 2016
Primary endpoint
9 May 2018
14 October 2018

Quick facts

Lead sponsorChildren's Hospital of Philadelphia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment303
Start date10 March 2016
Primary completion9 May 2018
Estimated completion14 October 2018
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Children's Hospital of Philadelphia

Who can join

Adults 5 to 12, any sex, with Attention-Deficit/Hyperactivity Disorder. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Vanderbilt Parent Rating Scales (VPRS) Primary · 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 1
GroupValue95% CI
ADHD Portal32.6± 11.8
ADHD Portal Plus Care Manager31.3± 10.8
Visit 2
GroupValue95% CI
ADHD Portal28.7± 12.2
ADHD Portal Plus Care Manager29.0± 11.4
Visit 3
GroupValue95% CI
ADHD Portal28.1± 12.1
ADHD Portal Plus Care Manager26.3± 11.6
Visit 4
GroupValue95% CI
ADHD Portal27.2± 12.1
ADHD Portal Plus Care Manager25.7± 11.1
Mean Goal Attainment Scale (GAS) Score by Timepoint Secondary · 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.

Visit 2
GroupValue95% CI
ADHD Portal2.92± 1.82
ADHD Portal Plus Care Manager2.67± 1.68
Visit 3
GroupValue95% CI
ADHD Portal2.93± 1.89
ADHD Portal Plus Care Manager3.01± 1.68
Visit 4
GroupValue95% CI
ADHD Portal3.03± 1.66
ADHD Portal Plus Care Manager2.86± 1.75
Treatment Initiation and Use of Services Secondary · 9-12 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 hea

Use of any services (Ever) : Yes
GroupValue95% CI
ADHD Portal79
ADHD Portal Plus Care Manager88
ADHD Portal40
ADHD Portal Plus Care Manager49
Use of ambulatory services (Ever) : Yes
GroupValue95% CI
ADHD Portal77
ADHD Portal Plus Care Manager87
ADHD Portal42
ADHD Portal Plus Care Manager49
Overnight Stay for Services (Ever) : Yes
GroupValue95% CI
ADHD Portal5
ADHD Portal Plus Care Manager6
ADHD Portal92
ADHD Portal Plus Care Manager118
Treatment Adherence and Use of Services Secondary · 9-12 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 co

Use of any service (Past 9 months)
GroupValue95% CI
ADHD Portal48
ADHD Portal Plus Care Manager51
ADHD Portal19
ADHD Portal Plus Care Manager29
Use of ambulatory services (Past 9 months)
GroupValue95% CI
ADHD Portal47
ADHD Portal Plus Care Manager50
ADHD Portal18
ADHD Portal Plus Care Manager29
Overnight Stay for Services (Ever)
GroupValue95% CI
ADHD Portal1
ADHD Portal Plus Care Manager2
ADHD Portal3
ADHD Portal Plus Care Manager4
School Performance Secondary · Baseline (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

Parent PROS : Visit 1
GroupValue95% CI
ADHD Portal2.82± 1.00
ADHD Portal Plus Care Manager2.77± 0.80
Parent PROS : Visit 2
GroupValue95% CI
ADHD Portal3.00± 1.01
ADHD Portal Plus Care Manager2.91± 0.80
Parent PROS : Visit 3
GroupValue95% CI
ADHD Portal3.03± 0.89
ADHD Portal Plus Care Manager3.04± 0.92
Parent PROS : Visit 4
GroupValue95% CI
ADHD Portal3.08± 0.96
ADHD Portal Plus Care Manager3.03± 0.90
Child PROS : Visit 1
GroupValue95% CI
ADHD Portal3.53± 0.77
ADHD Portal Plus Care Manager3.42± 0.79
Child PROS : Visit 2
GroupValue95% CI
ADHD Portal3.22± 0.93
ADHD Portal Plus Care Manager3.30± 0.81
Child PROS : Visit 3
GroupValue95% CI
ADHD Portal3.29± 0.85
ADHD Portal Plus Care Manager3.27± 0.77
Child PROS : Visit 4
GroupValue95% CI
ADHD Portal3.23± 0.83
ADHD Portal Plus Care Manager3.41± 0.86
Student Engagement Secondary · Baseline (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

Parent PROS : Visit 1
GroupValue95% CI
ADHD Portal2.98± 0.79
ADHD Portal Plus Care Manager2.93± 0.80
Parent PROS : Visit 2
GroupValue95% CI
ADHD Portal3.18± 0.85
ADHD Portal Plus Care Manager3.08± 0.80
Parent PROS : Visit 3
GroupValue95% CI
ADHD Portal3.18± 0.78
ADHD Portal Plus Care Manager3.09± 0.70
Parent PROS : Visit 4
GroupValue95% CI
ADHD Portal3.24± 0.82
ADHD Portal Plus Care Manager3.13± 0.80
Child PROS : Visit 1
GroupValue95% CI
ADHD Portal3.11± 0.82
ADHD Portal Plus Care Manager3.04± 0.80
Child PROS : Visit 2
GroupValue95% CI
ADHD Portal3.09± 0.09
ADHD Portal Plus Care Manager3.06± 0.73
Child PROS : Visit 3
GroupValue95% CI
ADHD Portal3.15± 0.94
ADHD Portal Plus Care Manager3.01± 0.78
Child PROS : Visit 4
GroupValue95% CI
ADHD Portal3.08± 0.83
ADHD Portal Plus Care Manager2.95± 0.79
Teacher Connectedness Secondary · Baseline (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

Child PROS : Visit 1
GroupValue95% CI
ADHD Portal3.81± 0.80
ADHD Portal Plus Care Manager3.75± 0.76
Child PROS : Visit 2
GroupValue95% CI
ADHD Portal3.85± 0.76
ADHD Portal Plus Care Manager3.82± 0.77
Child PROS : Visit 3
GroupValue95% CI
ADHD Portal3.86± 0.86
ADHD Portal Plus Care Manager3.77± 0.83
Child PROS : Visit 4
GroupValue95% CI
ADHD Portal3.75± 0.87
ADHD Portal Plus Care Manager3.72± 0.84
Peer Relationships Secondary · Baseline (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

Parent PROS : Visit 1
GroupValue95% CI
ADHD Portal3.56± 0.82
ADHD Portal Plus Care Manager3.54± 0.74
Parent PROS : Visit 2
GroupValue95% CI
ADHD Portal3.63± 0.75
ADHD Portal Plus Care Manager3.56± 0.75
Parent PROS : Visit 3
GroupValue95% CI
ADHD Portal3.61± 0.79
ADHD Portal Plus Care Manager3.63± 0.74
Parent PROS : Visit 4
GroupValue95% CI
ADHD Portal3.72± 0.80
ADHD Portal Plus Care Manager3.66± 0.72
Child PROS : Visit 1
GroupValue95% CI
ADHD Portal4.03± 0.74
ADHD Portal Plus Care Manager4.07± 0.71
Child PROS : Visit 2
GroupValue95% CI
ADHD Portal3.79± 0.75
ADHD Portal Plus Care Manager3.93± 0.84
Child PROS : Visit 3
GroupValue95% CI
ADHD Portal3.84± 0.74
ADHD Portal Plus Care Manager3.99± 0.72
Child PROS : Visit 4
GroupValue95% CI
ADHD Portal3.91± 0.83
ADHD Portal Plus Care Manager3.94± 0.79
Family Relationships Secondary · Baseline (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 bet

Child PROS : Visit 1
GroupValue95% CI
ADHD Portal3.81± 0.77
ADHD Portal Plus Care Manager3.82± 0.68
Child PROS : Visit 2
GroupValue95% CI
ADHD Portal3.83± 0.69
ADHD Portal Plus Care Manager3.80± 0.65
Child PROS : Visit 3
GroupValue95% CI
ADHD Portal3.96± 0.67
ADHD Portal Plus Care Manager3.72± 0.72
Child PROS : Visit 4
GroupValue95% CI
ADHD Portal3.81± 0.77
ADHD Portal Plus Care Manager3.79± 076
Engagement Measure Scores Secondary · 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.

Access
GroupValue95% CI
ADHD Portal3.43± 0.7
ADHD Portal Plus Care Manager3.52± 0.6
PFCC
GroupValue95% CI
ADHD Portal3.45± 0.7
ADHD Portal Plus Care Manager3.44± 0.7
Communication
GroupValue95% CI
ADHD Portal2.50± 1.1
ADHD Portal Plus Care Manager2.64± 1.0
Understanding
GroupValue95% CI
ADHD Portal2.89± 0.8
ADHD Portal Plus Care Manager3.02± 0.8

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Shared decision-making interventions for people with mental health conditions.
    Aoki Y, Yaju Y, Utsumi T, Sanyaolu L, et al · · 2022 · cited 34× · PMID 36367232 · DOI 10.1002/14651858.cd007297.pub3

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02716324.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing