NCT02145793

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 18, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 23, 2014

Completed
Last Updated

May 26, 2014

Status Verified

May 1, 2014

Enrollment Period

1.3 years

First QC Date

May 18, 2014

Last Update Submit

May 22, 2014

Conditions

Keywords

primary carepediatricsparentingeducation

Outcome Measures

Primary Outcomes (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.

    12 months

Secondary Outcomes (14)

  • Parent-rated ADHD symptoms

    Baseline

  • Parent-rated ADHD symptoms

    12 months

  • Child functioning at home

    Baseline

  • Child functioning at home

    12 months

  • Teacher report of child's ADHD symptoms

    baseline

  • +9 more secondary outcomes

Other Outcomes (2)

  • Participant feedback about the curriculum

    after each group visit over 365 days

  • Pediatric facilitator and staff feedback

    at the end of each group visit over 365 days

Study Arms (2)

ADHD Group Curriculum

ACTIVE COMPARATOR

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.

Behavioral: ADHD Group Curriculum

Control

NO INTERVENTION

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

Interventions

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

ADHD Group Curriculum

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • conduct disorder
  • autism
  • moderate to severe intellectual disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Indianapolis, Indiana, 46202, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental Disorders

Study Officials

  • Nerissa S Bauer, MD, MPH

    Indiana University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 18, 2014

First Posted

May 23, 2014

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

November 1, 2013

Last Updated

May 26, 2014

Record last verified: 2014-05

Locations