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ADHDNCT02145793

Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home

A study testing ADHD Group Curriculum in people with ADHD, run by Indiana University at 1 site 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) affects 8% of US youth. Even though evidence shows medications are effective in reducing ADHD symptoms, many families experience ongoing parenting stress around parent-child interactions. Children often have ongoing impairments in functioning. Read more about this study

Who is it for?
Ages 6 to 18 years
Conditions the study is for
ADHD
What is being tested?
ADHD Group Curriculum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
56 participants
Where
1 siteUnited States
Study dates
Jun 2012to Nov 2013
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 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • children with ADHD and their parents
  • children receiving routine ADHD follow-up care at the study clinic
  • if on medication, must be "stable" for 3 months and therefore not needing monthly clinic appointments to titrate medication

Who cannot join

  • conduct disorder
  • autism
  • moderate to severe intellectual disability

Trial locations and contacts

1 site in 1 country.

United States1 site

  • General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health

    Indianapolis, Indiana, 46202

Other trials in United States

About this study

Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence shows medications are effective in reducing ADHD symptoms, many families experience ongoing parenting stress around parent-child interactions. Children often have ongoing impairments in functioning. ADHD is a common condition identified and managed by primary care pediatricians. However current care in the clinic is not optimal to address parents' and children's needs around ADHD chronic care. Time is the biggest barrier. Group visits are a viable option to improve pediatric ADHD care, but requires extensive study. The goal of this proposed study is to test the feasibility and effectiveness of the group visit model for ADHD management within pediatric primary care. This study will be a randomized feasibility study that will generate important pilot data, as well as result in an innovative, exportable pediatric ADHD group curriculum for primary care practice.

Read the detailed description

The specific research aims of this proposal are:

Aim 1: Develop and test a group curriculum for parents of children (age 6 to 18 years) with ADHD to increase parental knowledge about ADHD and self-confidence in managing issues related to their child's functioning in school and home.

Aim 2: Develop and test a group curriculum for children (age 6 to 18 years) with ADHD to teach social and educational skills to improve adaptive functioning at home and school.

Aim 3: To assess any added benefits to the parents, children and providers (related to group visit logistics and satisfaction) the group visit model has over usual care.

Aim 4: To assess whether the group visit model can be done efficiently and effectively in the setting of an actual general pediatric practice.

Conditions
ADHD
Being tested
ADHD Group Curriculum
Keywords
primary care, pediatrics, parenting, education
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 CurriculumBehavioural

    Study specific ADHD Group curriculum was designed and implemented for the study. Parent curriculum included the following topics: What is ADHD, medications, educational advocacy, how to prevent behavioral issues and how to defuse common behavioral challenges and manage stress. Child curriculum included the following topics: what is ADHD, social skills and friendships, handling school and organization skills, understanding feelings and managing negative emotions

Study groups in NCT02145793
Study groupRoleWhat they receive
ADHD Group CurriculumActive comparatorParticipants assigned to the group visit intervention agree to participate in 5 group visits every 3 months rather than individual ADHD follow-up visits to the clinic. Parents and children participate in separate but simultaneously run groups. Group portion is 60 minutes and then parent-child dyads complete individual visits for medication titration and physical exam.
Receives: Behavioral: ADHD Group Curriculum
ControlNo interventionParticipants continue to go to the clinic for 5 routine ADHD follow-up visits to the clinic every 3 months as usual clinical protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of clinic visits during study period

    Feasibility of group visit model was measured as number of visits to the clinic by chart review. We also looked at the number of group visits a family attended based on the sign in sheet provided at the beginning of each session.

    Measured: 12 months

Secondary outcomes (14)

  1. Parent-rated ADHD symptoms

    Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms. Measures response to ADHD treatment, primarily medication.

    Measured: Baseline

  2. Parent-rated ADHD symptoms

    Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD. Used to assess response to treatment, usually medication.

    Measured: 12 months

  3. Child functioning at home

    Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire

    Measured: Baseline

  4. Child functioning at home

    Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.

    Measured: 12 months

  5. Teacher report of child's ADHD symptoms

    teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom. Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines. Monitors impact of ADHD treatment, usually medication.

    Measured: baseline

  6. teacher report of child's ADHD symptoms in school

    teachers received the validated Vanderbilt rating scale to rate student's ADHD symptoms in the classroom. Parents were given the tool at time of enrollment and asked to give to teacher as per clinical care guidelines. Monitors impact of ADHD treatment, usually medication.

    Measured: 12 months

  7. Child functioning at school

    teachers were invited to provide rating of child's adaptive functioning at school. Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.

    Measured: baseline

  8. teacher rating of child's functioning in school

    teachers were invited to provide rating of child's adaptive functioning at school. Parent given the tool at time of enrollment and instructed to give to teacher as per clinical care guidelines.

    Measured: 12 months

  9. Quality of Life

    Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.

    Measured: baseline

  10. Quality of Life

    Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.

    Measured: 12 months

  11. Parenting self-efficacy

    Parent reported sense of confidence using the Parenting Sense of Confidence Scale

    Measured: Baseline

  12. Parenting Self-efficacy

    Parent-reported sense of confidence using Parenting Sense of Confidence scale

    Measured: 12 months

  13. Parental knowledge, satisfaction towards medication treatment

    Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment

    Measured: baseline

  14. Parent knowledge and satisfaction towards medication treatment

    Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment

    Measured: 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 posted23 May 2014 (estimated)
  2. Study startJun 2012
  3. Primary completionOct 2013
  4. Study completionNov 2013

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
56 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02145793
Sponsor's protocol ID
1204008526
Status last verified
May 2014
First submitted
18 May 2014
Last updated
26 May 2014
Results posted
No
Data monitoring committee
Yes

Publications

  • Bauer NS, Szczepaniak D, Sullivan PD, Mooneyham G, Pottenger A, Johnson CS, Downs SM. Group Visits to Improve Pediatric Attention-Deficit Hyperactivity Disorder Chronic Care Management. J Dev Behav Pediatr. 2015 Oct;36(8):553-61. doi: 10.1097/DBP.0000000000000207.

    PubMed 26414089

Questions about this trial

What is this clinical trial studying?

A study testing ADHD Group Curriculum in people with ADHD, run by Indiana University 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 3 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 26 May 2014. 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?

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?

Number of clinic visits during study period (time frame: 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 NCT02145793, which also lists 1 linked publication.

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 26 May 2014.

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