Attention Deficit Hyperactivity DisorderNCT02105142
Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD
A study testing ADHD Group Visits, ADHD Group Visits plus Online Discussion Portal and Computer Decision Support in people with Attention Deficit Hyperactivity Disorder, run by Indiana University at 5 sites in United States.
Trial summary
Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, affecting approximately 8% of youth. Children with ADHD often have problems sustaining attention and completing multi-step commands and tasks of daily living, such as homework. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ADHD Group Visits, ADHD Group Visits plus Online Discussion Portal and Computer Decision Support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 5 sitesUnited States
- Study dates
- Apr 2014to Sep 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children 6 to 12 years of age with diagnosis of ADHD and their parents
- Children must receive medical care at participating study clinics
- Children must have diagnosis of ADHD based on parent and teacher diagnostic and statistical manual-IV rating scales
- Children can have co-existing Oppositional Defiant Disorder (ODD)
Who cannot join
- Children with co-existing diagnosis of Conduct Disorder (CD)
- Children with autism
- Children with moderate to severe mental handicap or other neurodevelopment disorder that would preclude active participation in group discussions
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
Indianapolis, Indiana, 46202
Eskenazi Health Center-Blackburn
Indianapolis, Indiana, 46208
Eskenazi Health Center- Forest Manor
Indianapolis, Indiana, 46226
Eskenazi Health Center-W. 38th Street
Indianapolis, Indiana, 46254
Eskenazi Health Center- Pecar
Indianapolis, Indiana, 46268
About this study
Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, affecting approximately 8% of youth. Children with ADHD often have problems sustaining attention and completing multi-step commands and tasks of daily living, such as homework. Pediatricians are often the first physicians to identify problems with children's functioning at home and at school. However, because of limited visit time, pediatricians often struggle with managing ADHD while trying to also cover a vast array of other primary care issues. Moreover, as there is a nationwide shortage of pediatric mental health specialists and access to parenting programs is limited, a critical need exists to develop interventions that form partnerships between behavioral and mental health specialists and the primary care pediatrician. One approach is to base interventions in the pediatric clinic to ensure children have access to appropriate treatment. Thus far, only a limited number of sites have this pediatric-mental health partnership.
Health information technology (HIT) has been used to enhance primary care management of ADHD. HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also to screen for co-existing disorders and provide timely parental education. An alternative strategy might be to use group visits (GV). GV afford more time with families and allows the pediatrician to facilitate more in-depth discussions. More importantly, the group model allows parents to learn from one another, normalizes parenting expectations, and addresses shared experiences of medication side effects and other factors related to adherence. Moreover, a group visit can be conducted in a physical location, such as the pediatric clinic, or be brought into the virtual world with the aid of social media. Virtual support groups for chronic care diseases have become an increasingly popular way for a community of individuals to exchange information and offer emotional support.
Read more
Prior to the adoption of these interventions into primary care practice, investigators must know which is best. Rigorous comparative effectiveness research (CER) can help to determine this. This proposal will compare a HIT based intervention to a GV strategy, with and without the use of social media. These 3 interventions will be compared based not only on clinical measures of interest but also on parent-defined patient outcomes. Prior research has largely focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction with little emphasis on understanding how patient-centered outcomes, such as the quality of life of families dealing with ADHD, are affected.
Building on previous work, the specific aims for this study are:
Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim 1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as quality of life and parental satisfaction with the intervention The three interventions will be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online discussion portal (GV+DP).
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ADHD Group Visits, ADHD Group Visits plus Online Discussion Portal, Computer Decision Support
- Keywords
- Attention deficit hyperactivity disorder, Interventions, Primary care, Pediatric
- 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.
ADHD Group VisitsBehavioural
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians
ADHD Group Visits plus Online Discussion PortalBehavioural
Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits.
Computer Decision SupportBehavioural
ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management
| Study group | Role | What they receive |
|---|---|---|
| Computer Decision Support | Active comparator | ADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management Receives: Behavioral: Computer Decision Support |
| ADHD Group visits | Active comparator | Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians Receives: Behavioral: ADHD Group Visits |
| ADHD Group Visits plus Online Discussion Portal | Active comparator | Parents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Online discussion portal access granted to parent participants and will allow parents to communicate with each other in between in-person group visits Receives: Behavioral: ADHD Group Visits plus Online Discussion Portal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Vanderbilt ADHD Rating Scale scores
ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.
Measured: Baseline & 12 months
Secondary outcomes (5)
Change in scores for pediatric quality of life
Quality of Life (generic core scales): 23 items, related to quality of life and child's needs in context of the family. Parent and child report.
Measured: Baseline & 12 months
Change in score of multidimensional scale of perceived social support scale
Social Support: 12-items perceptions on support
Measured: Baseline & 12 months
Parental Locus of Control-Short Form
Locus of Control: 25-items, degree parent feels in control of child behavior
Measured: Baseline
Change in scores related to adaptive functioning
13 items, parent-report, measuring adaptive functioning in the home using the Home Situations Questionnaire. Responses at each separate time point will be compared to the study specific Childhood ADHD and Family Impact Scale scores for correlation.
Measured: Baseline & 12 months
Change in scores on Childhood ADHD & Family Impact Scale
Study-specific tool, 9 items related to common challenges related to parenting based on feedback by patient advisory board
Measured: Baseline & 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2015
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Nerissa Bauer, Indiana University
- Investigators
- Nerissa S Bauer, MD, MPH, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02105142
- Sponsor's protocol ID
- 1305011436
- Status last verified
- Nov 2015
- First submitted
- 30 Mar 2014
- Last updated
- 9 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.
PubMed 23958768Bauer NS, Sullivan PD, Szczepaniak D, Stelzner SM, Pottenger A, Ofner S, Downs SM, Carroll AE. Attention Deficit-Hyperactivity Disorder Group Visits Improve Parental Emotional Health and Perceptions of Child Behavior. J Dev Behav Pediatr. 2018 Jul/Aug;39(6):461-470. doi: 10.1097/DBP.0000000000000575.
PubMed 29877990
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Primary Care-based Interventions for Pediatric ADHD
- ClinicalTrials.gov ID
- NCT02105142
- Acronym / sponsor ID
- 1305011436
- Conditions
- Attention Deficit Hyperactivity Disorder
- Keywords
- Attention deficit hyperactivity disorder, Interventions, Primary care, Pediatric
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 7 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Attention-deficit hyperactivity disorder (ADHD) is the most common neurobehavioral disorder of childhood, affecting approximately 8% of youth. Children with ADHD often have problems sustaining attention and completing multi-step commands and tasks of daily living, such as homework. Pediatricians are often the first physicians to identify problems with children's functioning at home and at school. However, because of limited visit time, pediatricians often struggle with managing ADHD while trying to also cover a vast array of other primary care issues. Moreover, as there is a nationwide shortage of pediatric mental health specialists and access to parenting programs is limited, a critical need exists to develop interventions that form partnerships between behavioral and mental health specialists and the primary care pediatrician. One approach is to base interventions in the pediatric clinic to ensure children have access to appropriate treatment. Thus far, only a limited number of sites have this pediatric-mental health partnership.
Health information technology (HIT) has been used to enhance primary care management of ADHD. HIT can improve pediatricians' ability not only to adhere to recommended guidelines, but also to screen for co-existing disorders and provide timely parental education. An alternative strategy might be to use group visits (GV). GV afford more time with families and allows the pediatrician to facilitate more in-depth discussions. More importantly, the group model allows parents to learn from one another, normalizes parenting expectations, and addresses shared experiences of medication side effects and other factors related to adherence. Moreover, a group visit can be conducted in a physical location, such as the pediatric clinic, or be brought into the virtual world with the aid of social media. Virtual support groups for chronic care diseases have become an increasingly popular way for a community of individuals to exchange information and offer emotional support.
Prior to the adoption of these interventions into primary care practice, investigators must know which is best. Rigorous comparative effectiveness research (CER) can help to determine this. This proposal will compare a HIT based intervention to a GV strategy, with and without the use of social media. These 3 interventions will be compared based not only on clinical measures of interest but also on parent-defined patient outcomes. Prior research has largely focused on measuring clinical outcomes such as treatment adherence and ADHD symptom reduction with little emphasis on understanding how patient-centered outcomes, such as the quality of life of families dealing with ADHD, are affected.
Building on previous work, the specific aims for this study are:
Aim 1. Compare the preliminary efficacy of three interventions to improve treatment of ADHD in the primary care setting Aim 1a) Compare the effectiveness of the three interventions on clinical measures such as parent and teacher rated ADHD symptoms and adaptive functioning Aim 1b) Compare the effectiveness of the three interventions on patient-centered outcomes such as quality of life and parental satisfaction with the intervention The three interventions will be: 1) Child Health Improvement through Computer Automation (CHICA) which is the health information technology innovation arm; 2) Group visits (GV); or 3) Group visits plus online discussion portal (GV+DP).
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer Decision Support | Active comparator | Behavioral: Computer Decision SupportADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management |
| ADHD Group visits | Active comparator | Behavioral: ADHD Group VisitsParents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians |
| ADHD Group Visits plus Online Discussion Portal | Active comparator | Behavioral: ADHD Group Visits plus Online Discussion PortalParents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Online discussion portal access granted to parent participants and will allow parents to communicate with each other in between in-person group visits |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children 6 to 12 years of age with diagnosis of ADHD and their parents
- Children must receive medical care at participating study clinics
- Children must have diagnosis of ADHD based on parent and teacher diagnostic and statistical manual-IV rating scales
- Children can have co-existing Oppositional Defiant Disorder (ODD)
Key exclusion criteria (3 listed)
- Children with co-existing diagnosis of Conduct Disorder (CD)
- Children with autism
- Children with moderate to severe mental handicap or other neurodevelopment disorder that would preclude active participation in group discussions
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 |
|---|---|---|
| ADHD Group VisitsParents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians | Behavioural | ADHD Group visits |
| ADHD Group Visits plus Online Discussion PortalParents and children attend separate but concurrently run group visits every three months; groups are facilitated by general pediatricians. Parent participants will be granted access to the online discussion portal to allow for communication in between in-person group visits. | Behavioural | ADHD Group Visits plus Online Discussion Portal |
| Computer Decision SupportADHD Module of the Child Health Improvement through Computer Automation (CHICA) system Designed to facilitate physician adherence to clinical care guidelines for ADHD identification and chronic care management | Behavioural | Computer Decision Support |
Primary outcome
Change in Vanderbilt ADHD Rating Scale scores
Time frame: Baseline & 12 months
ADHD symptoms as measured by parent-report and based on Diagnostic and Statistical Manual-IV diagnostic criteria.
5 secondary outcomes
Change in scores for pediatric quality of life
Time frame: Baseline & 12 months
Change in score of multidimensional scale of perceived social support scale
Time frame: Baseline & 12 months
Parental Locus of Control-Short Form
Time frame: Baseline
Change in scores related to adaptive functioning
Time frame: Baseline & 12 months
Change in scores on Childhood ADHD & Family Impact Scale
Time frame: Baseline & 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2015.
- Background: PubMed 23958768Carroll AE, Bauer NS, Dugan TM, Anand V, Saha C, Downs SM. Use of a computerized decision aid for ADHD diagnosis: a randomized controlled trial. Pediatrics. 2013 Sep;132(3):e623-9. doi: 10.1542/peds.2013-0933. Epub 2013 Aug 19.
- Derived from this study: PubMed 29877990Bauer NS, Sullivan PD, Szczepaniak D, Stelzner SM, Pottenger A, Ofner S, Downs SM, Carroll AE. Attention Deficit-Hyperactivity Disorder Group Visits Improve Parental Emotional Health and Perceptions of Child Behavior. J Dev Behav Pediatr. 2018 Jul/Aug;39(6):461-470. doi: 10.1097/DBP.0000000000000575.
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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.
Nerissa S Bauer, MD, MPH principal investigator
Indiana University
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ADHD Group Visits, ADHD Group Visits plus Online Discussion Portal and Computer Decision Support in people with Attention Deficit Hyperactivity Disorder, run by Indiana University at 5 sites 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 3 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 9 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 ADHD Rating Scale scores (time frame: Baseline & 12 months). 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 NCT02105142, which also lists 2 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 9 Nov 2015; AzTrials last refreshed its copy on 31 Oct 2026.