- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02495025
Testing the Effectiveness of Telephone-based Early Childhood Developmental Screening
24. september 2019 opdateret af: Paul Chung, University of California, Los Angeles
Developing and Testing a New Model for Telephone-based Early Childhood Developmental Screening and Care Coordination in Vulnerable Populations
The purpose of this research study is to test the effectiveness of telephone-based early childhood developmental screening and care coordination, compared to usual care in a primary care pediatrics clinic.
Investigators randomized 152 participants to one of two study arms, with the intervention families receiving developmental screening over the phone, and control families receiving usual care with their pediatricians.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Although the American Academy of Pediatrics (AAP) recommends universal early childhood developmental screening as part of routine well-child care, there have been many studies documenting that many pediatricians do not follow the AAP guidelines.
One intervention that has the potential to improve care, especially for low-income families, is centralized, telephone-based developmental screening, and care coordination for families whose children have developmental or behavioral concerns.
2-1-1 Los Angeles developed such an intervention and this study aims to test its effectiveness, in partnership with a local community clinic, using a randomized, controlled study design.
Investigators partnered with the Clinica Oscar A Romero, a federally-qualified health center in Los Angeles, serving predominantly low-income Latino families.
Investigators hope to enroll up to 300 families in the study.
Eligible families will have children ages 12 to 42 months of age who receive well-child care at the clinic.
As investigators obtain informed consent and enroll families, they will randomize study participants into intervention and control groups.
Intervention group families will be transferred to 211 Los Angeles to complete developmental screening over the phone, while control group families will go to their pediatricians for well-child care as usual.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
152
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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California
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Los Angeles, California, Forenede Stater, 90057
- Clinica Oscar A Romero
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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
1 år til 3 år (Barn)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- child receives well-child care at the clinic
- child is not already receiving intervention services for a developmental disability
- parent speaks Spanish or English well enough to be interviewed
Exclusion Criteria:
- child is younger than 12 months or older than 42 months at time of enrollment
- child is already receiving intervention services for a developmental disability
- parent is unable to speak Spanish or English well enough to be interviewed
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: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Telephone-based screening
Families randomized to the intervention arm will be connected with 211 Los Angeles for completion of developmental screening over the phone.
Screening will consist of three structured, validated, parent-report tools: the Parental Evaluation of Developmental Status (PEDS), the PEDS Developmental Milestones (PEDS:DM), and the Modified Checklist for Autism in Toddlers (M-CHAT).
If any developmental or behavioral concerns are present, the care coordinator at 211 Los Angeles will make appropriate referrals for developmental evaluation and intervention services.
A copy of the care plan generated from 211 will be sent to the child's primary care provider and included in the medical record.
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Ingen indgriben: Usual care
Children randomized to the control group will report for their well-child care visits as scheduled, and will receive clinic-based developmental screening and care coordination.
Any developmental or behavioral concerns will be directed to the child's pediatrician, as is the current clinical recommendation.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Screened With a Validated Tool
Tidsramme: 6 months
|
We will measure whether developmental screening was done using a validated instrument, as recommended by the AAP.
Specific screening instruments include the Parental Evaluation of Developmental Status (PEDS), the PEDS: Developmental Milestones (PEDS:DM), the Ages and Stages Questionnaires (ASQ), and/or the Modified Checklist for Autism in Toddlers (MCHAT), Revised version.
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6 months
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Number of Participants That Receive Services
Tidsramme: 6 months
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Based on medical record review, parent report, and 211 data, we will measure whether children are receiving intervention services, including Early Intervention or Special Education.
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6 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Number of Participants Referred for Evaluation/Services (Early Intervention or Early Childhood Special Education)
Tidsramme: 6 months
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Based on medical record review, parent report, and 211 data, we measured whether any referrals were made for children with developmental or behavioral concerns, for evaluation or services.
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6 months
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Primary Care Experiences: Percent of Anticipatory Guidance Topics Discussed & Percentage of Family-Centered Care Items That Participants Report as Usually or Always
Tidsramme: Baseline and 6 months
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Based on parent interviews we will assess family experiences with primary care including receipt of recommended well-child care, using recommended anticipatory guidance and family-centered care items from the Promoting Healthy Development Survey (PHDS)
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Baseline and 6 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Paul J Chung, MD, MS, Universilty of California, Los Angeles
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.
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 (Faktiske)
1. februar 2015
Primær færdiggørelse (Faktiske)
31. december 2016
Studieafslutning (Faktiske)
28. februar 2017
Datoer for studieregistrering
Først indsendt
8. juli 2015
Først indsendt, der opfyldte QC-kriterier
10. juli 2015
Først opslået (Skøn)
13. juli 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
14. oktober 2019
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. september 2019
Sidst verificeret
1. september 2019
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 15-000509
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 Udviklingshæmning
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