Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
22 maja 2014 zaktualizowane przez: 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.
Przegląd badań
Szczegółowy opis
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.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
56
Faza
- Nie dotyczy
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Indiana
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Indianapolis, Indiana, Stany Zjednoczone, 46202
- General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
6 lat do 18 lat (Dziecko, Dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Aktywny komparator: 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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Brak interwencji: 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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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Number of clinic visits during study period
Ramy czasowe: 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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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Parent-rated ADHD symptoms
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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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Inne miary wyników
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Participant feedback about the curriculum
Ramy czasowe: 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
Ramy czasowe: 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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów
1 czerwca 2012
Zakończenie podstawowe (Rzeczywisty)
1 października 2013
Ukończenie studiów (Rzeczywisty)
1 listopada 2013
Daty rejestracji na studia
Pierwszy przesłany
18 maja 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
20 maja 2014
Pierwszy wysłany (Oszacować)
23 maja 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
26 maja 2014
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
22 maja 2014
Ostatnia weryfikacja
1 maja 2014
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 1204008526
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .