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

ADHD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02145793
• Other study ID #: 1204008526
• Status: Completed
• Phase: N/A
• First received: May 18, 2014
• Last updated: May 22, 2014
• Start date: June 2012
• Est. completion date: November 2013

Study information

• Verified date: May 2014
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Indiana University Office of Research Administration Institutional Review Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• ADHD

Intervention

Behavioral:
• 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

Locations

Country	Name	City	State
United States	General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health	Indianapolis	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Participant feedback about the curriculum	parents and children separately complete a short 4 question survey about what they liked, what they did not like, what they are excited about doing after the group visit and suggestions for improvement. Data used to continually refine the curriculum. At the 5th group visit, participants participated in informal discussion about the group visit model and overall satisfaction with the intervention	after each group visit over 365 days	No
Other	Pediatric facilitator and staff feedback	collected informal feedback and reflection about the process, barriers and positive experiences overall about the group visit model and impact on the clinical workflow, suggestions for improvement that was used to continually refine the model for quality improvement	at the end of each group visit over 365 days	No
Primary	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	No
Secondary	Parent-rated ADHD symptoms	Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms. Measures response to ADHD treatment, primarily medication.	Baseline	Yes
Secondary	Parent-rated ADHD symptoms	Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD. Used to assess response to treatment, usually medication.	12 months	Yes
Secondary	Child functioning at home	Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire	Baseline	No
Secondary	Child functioning at home	Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.	12 months	No
Secondary	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.	baseline	Yes
Secondary	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.	12 months	Yes
Secondary	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.	baseline	No
Secondary	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.	12 months	No
Secondary	Quality of Life	Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.	baseline	No
Secondary	Quality of Life	Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.	12 months	No
Secondary	Parenting self-efficacy	Parent reported sense of confidence using the Parenting Sense of Confidence Scale	Baseline	No
Secondary	Parenting Self-efficacy	Parent-reported sense of confidence using Parenting Sense of Confidence scale	12 months	No
Secondary	Parental knowledge, satisfaction towards medication treatment	Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment	baseline	No
Secondary	Parent knowledge and satisfaction towards medication treatment	Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment	12 months	No