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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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

Other trials in United States

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).

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 groups in NCT02105142
Study groupRoleWhat they receive
Computer Decision SupportActive comparatorADHD 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 visitsActive comparatorParents 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 PortalActive comparatorParents 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.

  1. 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)
  1. 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

  2. Change in score of multidimensional scale of perceived social support scale

    Social Support: 12-items perceptions on support

    Measured: Baseline & 12 months

  3. Parental Locus of Control-Short Form

    Locus of Control: 25-items, degree parent feels in control of child behavior

    Measured: Baseline

  4. 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

  5. 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.

  1. First posted7 Apr 2014 (estimated)
  2. Study startApr 2014
  3. Primary completionSep 2015
  4. Study completionSep 2015

Resources

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)
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 23958768
  • Bauer 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

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.

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