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Systematically Adapted Delivery of the Family Check-Up

31. mars 2019 oppdatert av: Christina Studts

Systematically Adapted Delivery of the Family Check-Up in Underserved Communities

Early childhood disruptive behavior problems lead to significant costs to families and society, but can be reduced with behavioral parent training interventions. To increase the public health impact of these interventions, their feasibility, accessibility, and acceptability in high-need, underserved communities must be ensured. This pilot project will systematically adapt and pilot-test the delivery model of an existing effective parent training intervention for implementation in rural Appalachia, a region with many documented health disparities, high levels of poverty, and shortages of mental health providers. Community health workers in 5 rural Appalachian counties will be trained to deliver a behavioral parent training intervention. Each worker will deliver the intervention to 4 parent-child dyads.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

51

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Forente stater
    • Kentucky
      • Lexington, Kentucky, Forente stater, 40506
        • University of Kentuckyi

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

3 år og eldre (Barn, Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

Inclusion Criteria:

  • Parents: aged 18+ years, custodial guardian of child, can speak/read/understand English
  • Children: ages 3-5 years, lives full time in custodial guardian's home
  • Community health workers: aged 18+ years, currently employed at a partnering health department, able to speak/read/understand English

Exclusion Criteria:

  • Parents: has already accessed behavioral health services for the child, reports suicidal ideation or intent to harm self or others, participated in formative research for this study
  • Children: diagnosed with a severe developmental condition (i.e., significant developmental delay, autism, debilitating neurological condition)
  • Community health workers: none

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Helsetjenesteforskning
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Annen: Community Health Workers
Community health workers will complete a 5-day interventionist training to deliver a behavioral parent training intervention.
Atferdsmessig: interventionist training
Interventionists are trained in the delivery of the Family Check-Up program and deliver sessions to families in their community
Annen: Parent-Child Dyads
Parents and children will receive a behavioral parent training intervention delivered by community health workers.
Atferdsmessig: behavioral parent training
Parents receive up to 6 sessions of the Family Check-Up program

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility: Enrollment
Tidsramme: 2 weeks after final parent-child dyad completes the study
Percentage of invited parents who enroll in the study (obtained from process records)
2 weeks after final parent-child dyad completes the study

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility: Number of sessions completed
Tidsramme: 2 weeks after final parent-child dyad completes the study
Number of sessions completed by each parent-child dyad (obtained from process records)
2 weeks after final parent-child dyad completes the study
Feasibility: Interventionist-reported fidelity
Tidsramme: following each behavioral parent training intervention session
Fidelity Checklist (completed by community health workers)
following each behavioral parent training intervention session
Feasibility: Parent satisfaction
Tidsramme: 10 weeks after parent baseline
European Parent Satisfaction Scale about Early Intervention (EPASSEI) (completed by parents)
10 weeks after parent baseline
Interventionist satisfaction
Tidsramme: 2 weeks after final parent-child dyad completes study
Therapist Satisfaction Index (completed by community health workers)
2 weeks after final parent-child dyad completes study
Interventionist evidence-based practice attitudes
Tidsramme: 2 weeks after final parent-child dyad completes study
Evidence-Based Practice Attitude Scale-50 (completed by community health workers)
2 weeks after final parent-child dyad completes study
Interventionist self-efficacy
Tidsramme: 2 weeks after final parent-child dyad completes study
Counselor Activity Self-Efficacy Scale (completed by community health workers)
2 weeks after final parent-child dyad completes study

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Feasibility: Observer-rated fidelity
Tidsramme: Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
Family Check-Up COACH fidelity rating system (observer-rated videos of 10% of intervention sessions)
Throughout 10 weeks of behavioral parent training intervention per parent-child dyad
Costs: Training
Tidsramme: 2 weeks after final parent-child dyad completes study
Total costs of training (obtained from process records maintained by investigators)
2 weeks after final parent-child dyad completes study
Costs: Per-family interventionist time
Tidsramme: 2 weeks after final parent-child dyad completes study
Obtained from process records maintained by community health workers
2 weeks after final parent-child dyad completes study
Costs: Per-family interventionist travel
Tidsramme: 2 weeks after final parent-child dyad completes study
Obtained from process records maintained by community health workers
2 weeks after final parent-child dyad completes study
Costs: Supervision time
Tidsramme: 2 weeks after final parent-child dyad completes study
Obtained from process records maintained by community health workers
2 weeks after final parent-child dyad completes study
Costs: Number of contacts outside of intervention sessions
Tidsramme: 2 weeks after final parent-child dyad completes study
Obtained from process records maintained by community health workers
2 weeks after final parent-child dyad completes study

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Christina Studts

Samarbeidspartnere

National Institute of Mental Health (NIMH)

Etterforskere

  • Hovedetterforsker: Christina R Studts, PhD, University of Kentucky

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 (Faktiske)

20. februar 2017

Primær fullføring (Faktiske)

16. mai 2018

Studiet fullført (Faktiske)

26. juni 2018

Datoer for studieregistrering

Først innsendt

8. mars 2016

Først innsendt som oppfylte QC-kriteriene

10. mars 2016

Først lagt ut (Anslag)

16. mars 2016

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

2. april 2019

Siste oppdatering sendt inn som oppfylte QC-kriteriene

31. mars 2019

Sist bekreftet

1. mars 2019

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • R34MH106661 (U.S. NIH-stipend/kontrakt)

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

Nei

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

produkt produsert i og eksportert fra USA

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. .

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