Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
22 mei 2014 bijgewerkt door: Nerissa Bauer, Indiana University
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.
Studie Overzicht
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
56
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Indiana
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Indianapolis, Indiana, Verenigde Staten, 46202
- General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
6 jaar tot 18 jaar (Kind, Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Actieve vergelijker: 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.
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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
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Geen tussenkomst: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Number of clinic visits during study period
Tijdsspanne: 12 months
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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.
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12 months
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Parent-rated ADHD symptoms
Tijdsspanne: Baseline
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Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms.
Measures response to ADHD treatment, primarily medication.
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Baseline
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Parent-rated ADHD symptoms
Tijdsspanne: 12 months
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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
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Child functioning at home
Tijdsspanne: Baseline
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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
Tijdsspanne: 12 months
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Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
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12 months
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Teacher report of child's ADHD symptoms
Tijdsspanne: baseline
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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.
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baseline
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teacher report of child's ADHD symptoms in school
Tijdsspanne: 12 months
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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.
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12 months
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Child functioning at school
Tijdsspanne: baseline
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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
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teacher rating of child's functioning in school
Tijdsspanne: 12 months
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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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12 months
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Quality of Life
Tijdsspanne: 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
Tijdsspanne: 12 months
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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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12 months
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Parenting self-efficacy
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
Tijdsspanne: 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
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Participant feedback about the curriculum
Tijdsspanne: after each group visit over 365 days
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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
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 juni 2012
Primaire voltooiing (Werkelijk)
1 oktober 2013
Studie voltooiing (Werkelijk)
1 november 2013
Studieregistratiedata
Eerst ingediend
18 mei 2014
Eerst ingediend dat voldeed aan de QC-criteria
20 mei 2014
Eerst geplaatst (Schatting)
23 mei 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
26 mei 2014
Laatste update ingediend die voldeed aan QC-criteria
22 mei 2014
Laatst geverifieerd
1 mei 2014
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 1204008526
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