- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02145793
Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Indiana
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Indianapolis, Indiana, United States, 46202
- General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 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.
|
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
|
No Intervention: 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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of clinic visits during study period
Time Frame: 12 months
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Parent-rated ADHD symptoms
Time Frame: Baseline
|
Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms.
Measures response to ADHD treatment, primarily medication.
|
Baseline
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Parent-rated ADHD symptoms
Time Frame: 12 months
|
Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD.
Used to assess response to treatment, usually medication.
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12 months
|
Child functioning at home
Time Frame: Baseline
|
Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire
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Baseline
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Child functioning at home
Time Frame: 12 months
|
Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
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12 months
|
Teacher report of child's ADHD symptoms
Time Frame: baseline
|
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
|
teacher report of child's ADHD symptoms in school
Time Frame: 12 months
|
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
|
Child functioning at school
Time Frame: baseline
|
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.
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baseline
|
teacher rating of child's functioning in school
Time Frame: 12 months
|
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
|
Quality of Life
Time Frame: baseline
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Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
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baseline
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Quality of Life
Time Frame: 12 months
|
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
|
12 months
|
Parenting self-efficacy
Time Frame: Baseline
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Parent reported sense of confidence using the Parenting Sense of Confidence Scale
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Baseline
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Parenting Self-efficacy
Time Frame: 12 months
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Parent-reported sense of confidence using Parenting Sense of Confidence scale
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12 months
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Parental knowledge, satisfaction towards medication treatment
Time Frame: baseline
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Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
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baseline
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Parent knowledge and satisfaction towards medication treatment
Time Frame: 12 months
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Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
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12 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participant feedback about the curriculum
Time Frame: after each group visit over 365 days
|
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
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after each group visit over 365 days
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Pediatric facilitator and staff feedback
Time Frame: at the end of each group visit over 365 days
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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
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at the end of each group visit over 365 days
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 1204008526
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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