An interventional study of ADHD Group Curriculum in ADHD, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 6 Years to 18 Years. Per ClinicalTrials.gov, last updated 2014-05-26.
Sponsored by Indiana University · Not applicable, Interventional, and Health services research
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.
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.
1,548 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 254 are open to participants now.
This study's enrollment of 56 is below the median of 71 across 1,233 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.
Browse Attention Deficit Disorder with Hyperactivity studies →Indiana University is the lead sponsor of 982 studies on the registry; 199 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
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Exclusion Criteria:
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
Participants continue to go to the clinic for 5 routine ADHD follow-up visits to the clinic every 3 months as usual clinical protocol.
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
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.
Time frame: 12 months
Parent-rated ADHD symptoms
Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms. Measures response to ADHD treatment, primarily medication.
Time frame: Baseline
Parent-rated ADHD symptoms
Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD. Used to assess response to treatment, usually medication.
Time frame: 12 months
Child functioning at home
Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire
Time frame: Baseline
Child functioning at home
Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
Time frame: 12 months
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.
Time frame: baseline
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.
Time frame: 12 months
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.
Time frame: baseline
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.
Time frame: 12 months
Quality of Life
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
Time frame: baseline
Quality of Life
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
Time frame: 12 months
Parenting self-efficacy
Parent reported sense of confidence using the Parenting Sense of Confidence Scale
Time frame: Baseline
Parenting Self-efficacy
Parent-reported sense of confidence using Parenting Sense of Confidence scale
Time frame: 12 months
Parental knowledge, satisfaction towards medication treatment
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
Time frame: baseline
Parent knowledge and satisfaction towards medication treatment
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
Time frame: 12 months
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
Time frame: after each group visit over 365 days
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
Time frame: at the end of each group visit over 365 days
This study is completed, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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Attention Deficit Disorder with Hyperactivity →