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

22. maj 2014 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

56

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • General Pediatrics Clinic Medical Service Area 1 in Riley Hospital for Children at IU Health

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

6 år til 18 år (Barn, Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Sundhedstjenesteforskning
  • Tildeling: Randomiseret
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Adfærdsmæssigt: ADHD Group Curriculum
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
Ingen indgriben: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of clinic visits during study period
Tidsramme: 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.
12 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Parent-rated ADHD symptoms
Tidsramme: Baseline
Parents completed validated Vanderbilt Rating Scale regarding child's ADHD symptoms. Measures response to ADHD treatment, primarily medication.
Baseline
Parent-rated ADHD symptoms
Tidsramme: 12 months
Parents complete validated Vanderbilt Rating Scale to report child symptoms of ADHD. Used to assess response to treatment, usually medication.
12 months
Child functioning at home
Tidsramme: Baseline
Parent report of adaptive functioning of child in the home setting using the Home Situations Questionnaire
Baseline
Child functioning at home
Tidsramme: 12 months
Parents report of child's adaptive functioning in the home setting using the Home Situations Questionnaire.
12 months
Teacher report of child's ADHD symptoms
Tidsramme: 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.
baseline
teacher report of child's ADHD symptoms in school
Tidsramme: 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.
12 months
Child functioning at school
Tidsramme: 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.
baseline
teacher rating of child's functioning in school
Tidsramme: 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.
12 months
Quality of Life
Tidsramme: baseline
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
baseline
Quality of Life
Tidsramme: 12 months
Capture parent rating of quality of life related to ADHD using the Child Health Questionnaire-28 validated tool.
12 months
Parenting self-efficacy
Tidsramme: Baseline
Parent reported sense of confidence using the Parenting Sense of Confidence Scale
Baseline
Parenting Self-efficacy
Tidsramme: 12 months
Parent-reported sense of confidence using Parenting Sense of Confidence scale
12 months
Parental knowledge, satisfaction towards medication treatment
Tidsramme: baseline
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
baseline
Parent knowledge and satisfaction towards medication treatment
Tidsramme: 12 months
Parent report of knowledge, attitudes and satisfaction towards medication experiences with ADHD medication treatment
12 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Participant feedback about the curriculum
Tidsramme: 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
after each group visit over 365 days
Pediatric facilitator and staff feedback
Tidsramme: 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
at the end of each group visit over 365 days

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University

Efterforskere

  • Ledende efterforsker: Nerissa S Bauer, MD, MPH, Indiana University School of Medicine

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2012

Primær færdiggørelse (Faktiske)

1. oktober 2013

Studieafslutning (Faktiske)

1. november 2013

Datoer for studieregistrering

Først indsendt

18. maj 2014

Først indsendt, der opfyldte QC-kriterier

20. maj 2014

Først opslået (Skøn)

23. maj 2014

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

26. maj 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. maj 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • 1204008526

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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