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

NCT ID: NCT02145793

Last Updated: 2014-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

ADHD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ADHD Group Curriculum

Participants 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.

Group Type ACTIVE_COMPARATOR

ADHD Group Curriculum

Intervention Type BEHAVIORAL

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

Control

Participants continue to go to the clinic for 5 routine ADHD follow-up visits to the clinic every 3 months as usual clinical protocol.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ADHD Group Curriculum

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* conduct disorder
* autism
* moderate to severe intellectual disability
Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Indiana University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nerissa Bauer

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nerissa S Bauer, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Indiana University School of Medicine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Indianapolis, Indiana, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26414089 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

1204008526

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treating Sleep in Teens With ADHD
NCT04270812 COMPLETED NA
Cognitive Training Trial
NCT01133418 COMPLETED NA
ADHD/Me Bibliotherapy Study
NCT03620344 TERMINATED NA