Clinical trial NCT02145793: Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
Official title: Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ADHD
Keywords: primary care
pediatrics
parenting
education
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2014-05-23
Enrollment: 56
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of clinic visits during study period
timeFrame: 12 months
Secondary outcomes:
measure: Parent-rated ADHD symptoms
timeFrame: Baseline
measure: Parent-rated ADHD symptoms
timeFrame: 12 months
measure: Child functioning at home
timeFrame: Baseline
measure: Child functioning at home
timeFrame: 12 months
measure: Teacher report of child's ADHD symptoms
timeFrame: baseline
measure: teacher report of child's ADHD symptoms in school
timeFrame: 12 months
measure: Child functioning at school
timeFrame: baseline
measure: teacher rating of child's functioning in school
timeFrame: 12 months
measure: Quality of Life
timeFrame: baseline
measure: Quality of Life
timeFrame: 12 months
measure: Parenting self-efficacy
timeFrame: Baseline
measure: Parenting Self-efficacy
timeFrame: 12 months
measure: Parental knowledge, satisfaction towards medication treatment
timeFrame: baseline
measure: Parent knowledge and satisfaction towards medication treatment
timeFrame: 12 months
Other outcomes:
measure: Participant feedback about the curriculum
timeFrame: after each group visit over 365 days
measure: Pediatric facilitator and staff feedback
timeFrame: at the end of each group visit over 365 days
Locations:
city: Indianapolis
country: United States
facility: General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
state: Indiana
Study officials:
affiliation: Indiana University School of Medicine
name: Nerissa S Bauer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.