Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
22 maj 2014 uppdaterad av: 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.
Studieöversikt
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
56
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Indiana
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Indianapolis, Indiana, Förenta staterna, 46202
- General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
6 år till 18 år (Barn, Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Hälsovårdsforskning
- Tilldelning: Randomiserad
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Aktiv 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Number of clinic visits during study period
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Parent-rated ADHD symptoms
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Participant feedback about the curriculum
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
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Sponsor
Utredare
- Huvudutredare: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine
Publikationer och användbara länkar
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 juni 2012
Primärt slutförande (Faktisk)
1 oktober 2013
Avslutad studie (Faktisk)
1 november 2013
Studieregistreringsdatum
Först inskickad
18 maj 2014
Först inskickad som uppfyllde QC-kriterierna
20 maj 2014
Första postat (Uppskatta)
23 maj 2014
Uppdateringar av studier
Senaste uppdatering publicerad (Uppskatta)
26 maj 2014
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
22 maj 2014
Senast verifierad
1 maj 2014
Mer information
Termer relaterade till denna studie
Nyckelord
Andra studie-ID-nummer
- 1204008526
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