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Forbedring af tandpleje og mundsundhed hos børn med autismespektrumforstyrrelse

19. maj 2026 opdateret af: Coleen Cunningham, University of California, Irvine
Et randomiseret kontrolleret forsøg (på steder), der sammenligner effektiviteten af ​​det etablerede AIR-P Dental Toolkit (kontroltilstand) med et kombineret regime, der involverer Dental Toolkit og forældre-medieret adfærdsintervention (interventionstilstand) for at forbedre hjemmetandplejen, orale sundhedsresultater , og tandlægebesøgsoplevelser.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Deltagelse i rutinemæssig tandpleje er en væsentlig udfordring for børn med autismespektrumforstyrrelse (ASD) på grund af en række forskellige faktorer, herunder overvejelser relateret til ASD-symptomer og tilhørende angst og adfærdsbesvær. Mangel på rutinemæssig, effektiv tandpleje har bidraget til et betydeligt udækket sundhedsbehov for børn med ASD, som har øget risiko for overdreven plak, caries og orale infektioner.

Formålet med denne undersøgelse er at teste en forældretræningsintervention designet til at forbedre hjemmetandhygiejne, overensstemmelse med tandlægebesøg og orale sundhedsresultater hos børn med autismespektrumforstyrrelse. Familier til børn med en eksisterende diagnose ASD vil blive rekrutteret til deltagelse. Alle familier vil modtage Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit, som er designet til at give forældre vejledning og information om tandpleje og støttestrategier for børn med ASD. Nogle familier vil også deltage i en 10-ugers adfærdsbaseret forældretræningsintervention, der fokuserer på at forbedre hjemmetandplejen og besøgsoplevelser på tandklinikken.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

119

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
    • California
      • Irvine, California, Forenede Stater, 92705
        • University of California Irvine
    • Ohio
      • Columbus, Ohio, Forenede Stater, 43081
        • Nationwide Children's Hospital

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

3 år til 13 år (Barn)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Engelsktalende familier med børn i alderen 3 til 13 år og 11 måneder.
  • Aktuel diagnose af ASD bekræftet ved baseline vurdering.
  • Forældrerapporterede vanskeligheder med at deltage i tandpleje.
  • Bekræftet fravær af tandundersøgelser eller undersøgelser/besøg inden for de seneste 6 måneder.
  • Underserveret status som defineret af Medicaid berettigelse.

Ekskluderingskriterier:

  • Børn, der har en akut tandlidelse, der kræver akut behandling.
  • Børn, der i øjeblikket tager eller for nylig har ophørt med medicin, der påvirker mund- og tandkødssundheden.
  • Alt, hvad der efter vurderingen af ​​webstedets hovedefterforsker ville bringe forsøgspersonen i en uberettiget risiko eller væsentligt reducere deres bidrag til forsøgets mål på grund af manglende evne eller afvisning af at overholde forsøgsprocedurer og opfølgning.

Familier vil blive bedt om at afstå fra at deltage i adaptive adfærdsinterventioner eller terapier, der ikke er undersøgt, med fokus på tandhygiejne. Familier vil også blive bedt om ikke at deltage i tandscreeninger eller -undersøgelser uden for undersøgelsen i hele undersøgelsens varighed.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: AIR-P Dental Toolkit
Familier vil blive forsynet med Autism Intervention Research Network on Physical Health (AIR-P) Dental Toolkit.
Adfærdsmæssigt: AIR-P Dental Toolkit
AIR-P Dental Toolkit er designet til at give plejepersonale vejledning og information relateret til tandpleje og støttestrategier for børn med autismespektrumforstyrrelse.
Eksperimentel: Parent Training
Families randomized to the Parent Training condition will be provided with the AIR-P Dental Toolkit and individual behavioral parent training comprised of 7 core in-person sessions, including a home visit and a dental office coach, and 4 phone booster sessions.
Adfærdsmæssigt: AIR-P Dental Toolkit
AIR-P Dental Toolkit er designet til at give plejepersonale vejledning og information relateret til tandpleje og støttestrategier for børn med autismespektrumforstyrrelse.
Adfærdsmæssigt: Forældretræning
Forældretræningsinterventionen integrerer strategier, der har vist sig at være effektive til: 1) at forbedre overholdelse af tandpleje, 2) forbedre tandoplevelser for børn med neurotypisk udvikling og høje niveauer af tandlægeskræk, og 3) evidensbaserede adfærdsteknikker etableret for børn med autismespektrumforstyrrelse.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Frequency of Tooth Brushing at Home
Tidsramme: Difference in brushing frequency between Baseline and 6 months
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Difference in brushing frequency between Baseline and 6 months
Frequency of Tooth Brushing at Home
Tidsramme: Difference in brushing frequency between Baseline and 3 months
Parent-reported frequency of successful (twice-daily) child tooth brushing completed at home during the past week.
Difference in brushing frequency between Baseline and 3 months
Child Oral Health According to Standardized Measures From Visual Exam
Tidsramme: Difference in oral health between Baseline and 6 months
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
Difference in oral health between Baseline and 6 months
Child Oral Health According to Standardized Measures From Visual Exam
Tidsramme: Difference in oral health between Baseline child and 3 months
Dentist ratings of child oral health according to standardized measures from visual exam. Blinded dentists used a standard Visual Plaque Index (VPI) to rate the buccal and lingual non-restored surfaces of index teeth on a 0 to 5 scale (0 = no plaque, 5 = plaque on more than two-thirds of tooth surface). Higher scores index greater visual plaque. VPI Score =Total Score (Max + Mand) / # Surfaces Examined
Difference in oral health between Baseline child and 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Child Behavior During Tooth Brushing at Home According to Questionnaire
Tidsramme: Difference in child behavior between Baseline and 6 months
Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).
Difference in child behavior between Baseline and 6 months
Child Behavior During Tooth Brushing at Home According to Questionnaire
Tidsramme: Difference in child behavior between Baseline and 3 months
Parent-reported child behavioral compliance with home dental hygiene during past week according to questionnaire. Parents reported on the occurrence and severity of 8 behavior problems during the past week's oral hygiene activities (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Higher scores index greater behavior problems during home oral hygiene. Items were averaged to produce a single score (α = 0.91).
Difference in child behavior between Baseline and 3 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Tidsramme: Difference in Caries between Baseline and 6 months
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT) to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The scale is from 0 to 32, with 32 being the worst score.
Difference in Caries between Baseline and 6 months
Blinded Dentist Ratings of Caries Using the Decayed, Missing, and Filled Teeth Index.
Tidsramme: Difference in Caries between Baseline and 3 months
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F).The scale range is 0-32 with 32 being worse.
Difference in Caries between Baseline and 3 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Tidsramme: Difference in decayed teeth between baseline to 6 months
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range is 0-32 with 32 being worse.
Difference in decayed teeth between baseline to 6 months
Blinded Dentist Ratings of Decayed Teeth Using the Decayed, Missing, and Filled Teeth Index.
Tidsramme: Difference in decayed teeth between baseline and 3 months
Dentists completed the Decayed, Missing, and Filled Teeth Index (dmft/DMFT)64 to document the presence and progression of fullmouth caries. The dmft/DMFT indicates the number of primary/permanent teeth that are decayed (d/D), missing due to caries (m/M), and filled (f/F). The d2/D2 code represents clinically detectable cavitated lesions. The scale range 0-32 with 32 being worse.
Difference in decayed teeth between baseline and 3 months
Observed Child Anxiety and Behavior at the Dental Office Visit (Venham Anxiety and Behavior Scales)
Tidsramme: Difference in anxiety and behavior between Baseline and 6 months
Observed child anxiety and behavior at the dental office visit as indexed by observer ratings on the Venham Anxiety and Behavior Scales (aggregate composite). The scale is 0-5, 5 representing worse.
Difference in anxiety and behavior between Baseline and 6 months
Dentist-reported Child Behavioral Compliance During Dental Office Visit as Indexed by Questionnaire
Tidsramme: Difference in behavioral compliance between baseline and at 6 months
Dentist-reported child behavioral compliance with dental visit as indexed by questionnaire. Dentists reported on the occurrence and severity of 8 behavior problems during the dental visit (not listening, difficulty sitting/standing still, actively resisting, eloping, fearful/anxious behaviors, screaming/yelling, aggression, and self-injury) using a 0 to 9 scale (0 = no problem, 9 = severe problem). Items were averaged to produce a single score.
Difference in behavioral compliance between baseline and at 6 months
Completion of Dental Visit Procedures According to Questionnaire
Tidsramme: Difference between completion of dental visit procedures at baseline and at 6 months
Dentist-reported completion of visit procedures according to questionnaire (severity of behavior during visit procedures). Behavior problems rated using a 0 to 9 scale (0 = no problem, 9 = severe problem). 9 represents a worse outcome.
Difference between completion of dental visit procedures at baseline and at 6 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Family Impact Questionnaire (FIQ)
Tidsramme: Difference in parent-reported parenting stress at baseline and at 6 months
Parenting stress associated with parenting the target autistic child. Negative Impact Composite range 0-82; higher scores index greater parenting stress.
Difference in parent-reported parenting stress at baseline and at 6 months
Parenting Sense of Competence Scale (PSOC)
Tidsramme: Difference in parent-reported perceived parenting competence between baseline and 6 months
Parent-reported perceived parenting self-efficacy according to questionnaire, total score; range 16-96; higher scores index greater parenting self-efficacy.
Difference in parent-reported perceived parenting competence between baseline and 6 months

Samarbejdspartnere og efterforskere

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

Sponsor

University of California, Irvine

Samarbejdspartnere

Massachusetts General Hospital
Nationwide Children's Hospital
California State University, Fullerton
Healthy Smiles for Kids of Orange County

Efterforskere

  • Studiestol: Robin Steinberg-Epstein, MD, University of California, Irvine
  • Ledende efterforsker: Rachel M Fenning, PhD, University of California-Irvine; California State University-Fullerton
  • Ledende efterforsker: Eric Butter, PhD, Nationwide Children's Hospital

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. december 2016

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

1. juni 2019

Datoer for studieregistrering

Først indsendt

20. december 2016

Først indsendt, der opfyldte QC-kriterier

23. december 2016

Først opslået (Anslået)

26. december 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

15. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

19. maj 2026

Sidst verificeret

1. april 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20163043

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

Ingen plan om at dele IPD-data ud over samarbejdswebsteder (MGH og NCH).

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 .

Kliniske forsøg med Autismespektrumforstyrrelse

Kliniske forsøg med AIR-P Dental Toolkit

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Rwanda

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner