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Completed

NCT Number: NCT02145793

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

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADHD Group Curriculum

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. Child functioning at home

    Time frame: Baseline

    Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire

  4. Child functioning at home

    Time frame: 12 months

    Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. Quality of Life

    Time frame: baseline

    Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.

  10. 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.

  11. Parenting self-efficacy

    Time frame: Baseline

    Parent reported sense of confidence using the Parenting Sense of Confidence Scale

  12. Parenting Self-efficacy

    Time frame: 12 months

    Parent-reported sense of confidence using Parenting Sense of Confidence scale

  13. Parental knowledge, satisfaction towards medication treatment

    Time frame: baseline

    Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment

  14. Parent knowledge and satisfaction towards medication treatment

    Time frame: 12 months

    Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment

Other outcomes

  1. 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

  2. Pediatric facilitator and staff feedback

    Time frame: at the end of each group visit over 365 days

    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

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 23, 2014
Registry last updated
May 26, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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