Attention-Deficit/Hyperactivity DisorderADHD-LinkNCT02716324
Communication to Improve Shared Decision-Making in ADHD
A study testing Care Manager CM) and ADHD Portal in people with Attention-Deficit/Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 12 years
- Conditions the study is for
- Attention-Deficit/Hyperactivity Disorder
- What is being tested?
- Care Manager CM) and ADHD Portal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2016to 14 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
About this study
Official title: Communication to Improve Shared Decision-Making in Attention-Deficit/Hyperactivity Disorder
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.
Read the 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.
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Being tested
- Care Manager CM), ADHD Portal
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Shared-Decision Making, Care Manager, Children, Parents, Teachers
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Care Manager CM)Behavioural
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.
ADHD PortalOther
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.
| Study group | Role | What they receive |
|---|---|---|
| ADHD Portal | Active comparator | In this arm, the ADHD Portal was 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. Receives: Other: ADHD Portal |
| ADHD Portal plus Care Manager (CM) | Experimental | In this arm, the ADHD Portal was combined with the CM. Clinicians, teachers, and parents used the ADHD Portal as standard of care. In addition, clinicians, teachers, parents, and any external mental health providers interacted with a CM, who had access to information contained in the ADHD Portal. Receives: Behavioral: Care Manager CM); Other: ADHD Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Secondary outcomes (9)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: 9-12 months (Visit 4)
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.
Measured: 9-12 months (Visit 4)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
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.
Measured: Visit 4 (9-12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2016 (estimated)
- Study start10 Mar 2016
- Primary completion9 May 2018
- Study completion14 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Attention-Deficit/Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- James Guevara, MD MPH, Principal investigator, Children's Hospital of Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02716324
- Sponsor's protocol ID
- 15-012456
- Acronym
- ADHD-Link
- Status last verified
- Nov 2019
- First submitted
- 10 Mar 2016
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A complete, cleaned, and de-identified dataset will be made available to the Patient-Centered Outcomes Research Institute (PCORI) and other investigators after all analyses have been conducted and within nine months of the end of the final year of funding. To obtain this data set, other investigators may contact the study PI who will provide a data sharing agreement. The data sharing agreement will permit the data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available electronically or via a secure file transfer protocol (FTP) site.
Publications
Guevara JP, Rothbard A, Shera D, Zhao H, Forrest CB, Kelleher K, Schwarz D. Correlates of behavioral care management strategies used by primary care pediatric providers. Ambul Pediatr. 2007 Mar-Apr;7(2):160-6. doi: 10.1016/j.ambp.2006.12.006.
PubMed 17368411Forrest CB, Glade GB, Baker AE, Bocian AB, Kang M, Starfield B. The pediatric primary-specialty care interface: how pediatricians refer children and adolescents to specialty care. Arch Pediatr Adolesc Med. 1999 Jul;153(7):705-14. doi: 10.1001/archpedi.153.7.705.
PubMed 10401803Homonoff EE, Maltz PF. Developing and maintaining a coordinated system of community-based services to children. Community Ment Health J. 1991 Oct;27(5):347-58. doi: 10.1007/BF00752385.
PubMed 1934995Guevara JP, Feudtner C, Romer D, Power T, Eiraldi R, Nihtianova S, Rosales A, Ohene-Frempong J, Schwarz DF. Fragmented care for inner-city minority children with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Oct;116(4):e512-7. doi: 10.1542/peds.2005-0243.
PubMed 16199679Wolraich ML, Bickman L, Lambert EW, Simmons T, Doffing MA. Intervening to improve communication between parents, teachers, and primary care providers of children with ADHD or at high risk for ADHD. J Atten Disord. 2005 Aug;9(1):354-68. doi: 10.1177/1087054705278834.
PubMed 16371681Guevara JP, Power TJ, Bevans K, Snitzer L, Leavy S, Stewart D, Broomfield C, Shah S, Grundmeier R, Michel JJ, Berkowitz S, Blum NJ, Bryan M, Griffis H, Fiks AG. Improving Care Management in Attention-Deficit/Hyperactivity Disorder: An RCT. Pediatrics. 2021 Aug;148(2):e2020031518. doi: 10.1542/peds.2020-031518. Epub 2021 Jul 19.
PubMed 34281997
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Communication to Improve Shared Decision-Making in Attention-Deficit/Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT02716324
- Acronym / sponsor ID
- ADHD-Link / 15-012456
- Conditions
- Attention-Deficit/Hyperactivity Disorder
- Keywords
- Attention-Deficit/Hyperactivity Disorder, Shared-Decision Making, Care Manager, Children, Parents, Teachers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 10 Mar 2016 (actual)
- Primary completion
- 9 May 2018 (actual)
- Study completion
- 14 Oct 2018 (actual)
- First posted
- 23 Mar 2016 (estimated)
- Results
- Posted 27 Sep 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD Portal | Active comparator | Other: ADHD PortalIn this arm, the ADHD Portal was 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 plus Care Manager (CM) | Experimental | Behavioral: Care Manager CM), Other: ADHD PortalIn this arm, the ADHD Portal was combined with the CM. Clinicians, teachers, and parents used the ADHD Portal as standard of care. In addition, clinicians, teachers, parents, and any external mental health providers interacted with a CM, who had access to information contained in the ADHD Portal. |
Who may qualify
- Ages
- 5 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care 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. | Behavioural | ADHD Portal plus Care Manager (CM) |
| ADHD PortalThe 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. | Other | ADHD Portal, ADHD Portal plus Care Manager (CM) |
Primary outcome
Change in Vanderbilt Parent Rating Scales (VPRS)
Time frame: 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.
9 secondary outcomes
Mean Goal Attainment Scale (GAS) Score by Timepoint
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Treatment Initiation and Use of Services
Time frame: 9-12 months (Visit 4)
Treatment Adherence and Use of Services
Time frame: 9-12 months (Visit 4)
School Performance
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Student Engagement
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Teacher Connectedness
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Peer Relationships
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Family Relationships
Time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)
Engagement Measure Scores
Time frame: Visit 4 (9-12 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17368411Guevara JP, Rothbard A, Shera D, Zhao H, Forrest CB, Kelleher K, Schwarz D. Correlates of behavioral care management strategies used by primary care pediatric providers. Ambul Pediatr. 2007 Mar-Apr;7(2):160-6. doi: 10.1016/j.ambp.2006.12.006.
- Background: PubMed 10401803Forrest CB, Glade GB, Baker AE, Bocian AB, Kang M, Starfield B. The pediatric primary-specialty care interface: how pediatricians refer children and adolescents to specialty care. Arch Pediatr Adolesc Med. 1999 Jul;153(7):705-14. doi: 10.1001/archpedi.153.7.705.
- Background: PubMed 1934995Homonoff EE, Maltz PF. Developing and maintaining a coordinated system of community-based services to children. Community Ment Health J. 1991 Oct;27(5):347-58. doi: 10.1007/BF00752385.
- Background: PubMed 16199679Guevara JP, Feudtner C, Romer D, Power T, Eiraldi R, Nihtianova S, Rosales A, Ohene-Frempong J, Schwarz DF. Fragmented care for inner-city minority children with attention-deficit/hyperactivity disorder. Pediatrics. 2005 Oct;116(4):e512-7. doi: 10.1542/peds.2005-0243.
- Background: PubMed 16371681Wolraich ML, Bickman L, Lambert EW, Simmons T, Doffing MA. Intervening to improve communication between parents, teachers, and primary care providers of children with ADHD or at high risk for ADHD. J Atten Disord. 2005 Aug;9(1):354-68. doi: 10.1177/1087054705278834.
- Derived from this study: PubMed 34281997Guevara JP, Power TJ, Bevans K, Snitzer L, Leavy S, Stewart D, Broomfield C, Shah S, Grundmeier R, Michel JJ, Berkowitz S, Blum NJ, Bryan M, Griffis H, Fiks AG. Improving Care Management in Attention-Deficit/Hyperactivity Disorder: An RCT. Pediatrics. 2021 Aug;148(2):e2020031518. doi: 10.1542/peds.2020-031518. Epub 2021 Jul 19.
- Individual participant dataSharing planned: Yes. A complete, cleaned, and de-identified dataset will be made available to the Patient-Centered Outcomes Research Institute (PCORI) and other investigators after all analyses have been conducted and within nine months of the end of the final year of funding. To obtain this data set, other investigators may contact the study PI who will provide a data sharing agreement. The data sharing agreement will permit the data set to be shared once an Institutional Review Board (IRB) protocol has been approved at the investigators' home institution and the investigators have signed a pledge to not attempt to identify individual study subjects. The data set will be made available electronically or via a secure file transfer protocol (FTP) site.
Related trials for Attention-Deficit/Hyperactivity Disorder
Not yet recruitingObservational study
Phase 1: Thrive Together: A Feasibility and Acceptability Evaluation of Peer Mentoring for High Schoolers With ADHD and Their Caregivers
Attention-Deficit/Hyperactivity Disorder (ADHD)
RecruitingObservational study
Augmenting Parent Management Training for Child Temper Outbursts Using a Digital Tool
Disruptive Behavior Disorders, Conduct Disorder
RecruitingObservational study
Psychotherapy for Irritability in Youth: Comparing Active Treatment to Nonactive Psychoeducation Supportive Psychotherapy
Irritability, Disruptive Mood Dysregulation Disorder
Active, not recruiting
Parent-Educator Action Response
Attention Deficit and Disruptive Behavior Disorders
RecruitingPhase 3
A Long-term Trial of EB-1020 in Adult Patients With ADHD
Attention Deficit Hyperactivity Disorder (ADHD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
James Guevara, MD MPH principal investigator
Children's Hospital of Philadelphia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care Manager CM) and ADHD Portal in people with Attention-Deficit/Hyperactivity Disorder, run by Children's Hospital of Philadelphia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Sep 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Vanderbilt Parent Rating Scales (VPRS) (time frame: Baseline (Visit 1), 3 months (Visit 2), 6 months (Visit 3), and 9-12 months (Visit 4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02716324, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.