A Family Centered Intervention to Promote Optimal Child Development
30. august 2016 oppdatert av: Children's Hospital of Philadelphia
A Family Centered Intervention to Promote Optimal Child Development at the Interface of the Health System and Community
This is a randomized controlled trial aimed at assessing the effectiveness of a patient decision aid (PDA) and text message reminder in promoting early intervention referral completion when infants and toddlers are identified with a developmental concern in the pediatric medical home.
Subjects will be randomized to one of two study arms- (1) intervention (2) control condition.
Subjects in the intervention arm will watch a video PDA and will receive a text message reminder approximately 7 to 14 business days after enrollment if they agree to the early intervention referral.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
64
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, Forente stater, 19104
- Children's Hospital of Philadelphia
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
2 dager til 3 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Parent-child dyads in which the child is age 0 to 36 months screening positive for developmental concern and receiving care at a practice within Children's Hospital of Philadelphia Pediatric Research Consortium (PeRC).
- Caregivers able to give permission (informed consent).
Exclusion Criteria:
- Primary language other than English
- Children already enrolled in early intervention
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Patient Decision Aid
After positive screen for a developmental concern the intervention group will receive the Patient Decision Aid (PDA), as well as, a text message reminder to follow up with Early Intervention.
|
Short informational video on developmental delays and early intervention services aimed at helping parents make an informed decision about whether to pursue early intervention services.
|
|
Ingen inngripen: Routine Care
After screening positive for a potential development delay those in the control arm will receive routine care, in this case, a handout explaining Early Intervention services.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Difference in the Number of Participants Who Completed Early Intervention Intake and Evaluation Visits Between Treatment Groups
Tidsramme: Up to 1 year after randomization
|
Completed intake and evaluation by the early intervention (EI) agency was assessed by parent report and by chart review.
A member of the study team contacted parents within 6 months of the first study visit to obtain this information.
Additionally, a chart review seeking written feedback information regarding referral disposition from the EI agency was completed.
|
Up to 1 year after randomization
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Parental Knowledge and Attitudes From Pre- to Post-Intervention
Tidsramme: Up to 7 days
|
Pre and post knowledge and attitudes regarding developmental delay and early intervention (EI) were assessed by asking participants to respond to 14 statements using a 6 point Likert scale that ranged from strongly disagree to strongly agree.
Questions mapped to the video decision aid content viewed by participants.
Participants in the intervention arm completed the questions before and after watching the video and participants in the control arm completed the questions sequentially.
Secondary outcome measures assessed in the survey included Parent Uncertainty About Early Intervention and Parental Predisposition for Early Intervention.
|
Up to 7 days
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Parent Uncertainty About Early Intervention
Tidsramme: Up to 7 days
|
Parental uncertainty about whether to enroll their child in Early Intervention will be evaluated using a survey.
|
Up to 7 days
|
|
Parental Predisposition for Early Intervention
Tidsramme: Up to 7 days
|
Parental predisposition for early intervention services will be measured using surveys.
|
Up to 7 days
|
|
Feasibility of the Patient Decision Aid
Tidsramme: Up to 7 days
|
The feasibility of the patient decision aid (PDA) will be measured by calculating the number of individuals who refuse to participate, time that it takes to complete the PDA, and the number of patients who complete the Early Intervention referral.
|
Up to 7 days
|
|
Acceptability of the Patient Decision Aid for Early Intervention Referral
Tidsramme: Up to 7 days
|
The acceptability of using the patient decision aid for early intervention will be assessed by having patients and providers complete surveys on the intervention.
|
Up to 7 days
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Alexander Fiks, MD, MSCE, Children's Hospital of Philadelphia
- Hovedetterforsker: Manuel Jimenez, MD, MS, Children's Hospital of Philadelphia
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2013
Primær fullføring (Faktiske)
1. juli 2015
Studiet fullført (Faktiske)
1. juli 2016
Datoer for studieregistrering
Først innsendt
9. september 2013
Først innsendt som oppfylte QC-kriteriene
9. september 2013
Først lagt ut (Anslag)
13. september 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. oktober 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
30. august 2016
Sist bekreftet
1. august 2016
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 13-010441
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .