Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

22. Mai 2014 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

56

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

6 Jahre bis 18 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Versorgungsforschung
  • Zuteilung: Zufällig
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver 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.
Verhalten: 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
Kein Eingriff: 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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of clinic visits during study period
Zeitfenster: 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

Sekundäre Ergebnismessungen

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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Participant feedback about the curriculum
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Indiana University

Ermittler

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

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. Juni 2012

Primärer Abschluss (Tatsächlich)

1. Oktober 2013

Studienabschluss (Tatsächlich)

1. November 2013

Studienanmeldedaten

Zuerst eingereicht

18. Mai 2014

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. Mai 2014

Zuerst gepostet (Schätzen)

23. Mai 2014

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

26. Mai 2014

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

22. Mai 2014

Zuletzt verifiziert

1. Mai 2014

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Andere Studien-ID-Nummern

  • 1204008526

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur ADHS

Klinische Studien zur ADHD Group Curriculum

Suchen Sie nach ähnlichen Studien

Sponsoren und Mitarbeiter

Krankheiten

Drogeninterventionen

CROs by country

CROs in South Africa

Bedingungen

Seltene Krankheiten

Drogeninterventionen

Nahrungsergänzungsmittel

Sponsor / Mitarbeiter

Standorte

Abonnieren