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

22 maggio 2014 aggiornato da: 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.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

56

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 6 anni a 18 anni (Bambino, Adulto)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Comportamentale: 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
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Number of clinic visits during study period
Lasso di tempo: 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

Misure di risultato secondarie

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

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Participant feedback about the curriculum
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Indiana University

Investigatori

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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2012

Completamento primario (Effettivo)

1 ottobre 2013

Completamento dello studio (Effettivo)

1 novembre 2013

Date di iscrizione allo studio

Primo inviato

18 maggio 2014

Primo inviato che soddisfa i criteri di controllo qualità

20 maggio 2014

Primo Inserito (Stima)

23 maggio 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

26 maggio 2014

Ultimo aggiornamento inviato che soddisfa i criteri QC

22 maggio 2014

Ultimo verificato

1 maggio 2014

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 1204008526

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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