- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07750054
Testing the Impact of the Parenting Young Children Check-up
3. august 2026 opdateret af: Lucy (Kathleen) McGoron, Ph.D., Wayne State University
Randomized Clinical Trial of the Parenting Young Children Check-up in Pediatric Primary Care
The proposed project aims to evaluate the Parenting Young Children Check-up (PYCC) through a randomized clinical trial in a pediatric primary care practice in Detroit that primarily serves low-income families.
Fifty parents will be randomized to intervention (n = 25) or control (n = 25) conditions.
We will follow up with parents 1 month and 3-months later to test the impact of the program on children's behavioral health/disruptive behavior problems, parenting, and parenting stress and to examine how much parents in the intervention group make use of and report satisfaction with the PYCC program.
Studieoversigt
Status
Rekruttering
Intervention / Behandling
Detaljeret beskrivelse
This study will test three hypotheses.
First, we hypothesize that randomization to the PYCC intervention group, as compared to the control group, will be related to reduced child behavioral health challenges and disruptive behavior problems.
Second, we hypothesize that randomization to the PYCC intervention group, as compared to control, will be related to improved positive parenting and reduced parenting stress.
Third, for parents in the intervention group, we hypothesize there will be high rates of module use on the PYCC website (i.e., >50%).
Finally, for parents in the intervention group, we also hypothesize that there will be high rates of satisfaction with the PYCC overall and with each PYCC module.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
50
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Lucy McGoron
- Telefonnummer: 313-664-2500
- E-mail: Lucy.K.McGoron@wayne.edu
Studiesteder
-
-
Michigan
-
Detroit, Michigan, Forenede Stater, 48202
- Rekruttering
- Wayne Pediatrics
-
Kontakt:
- Lucy McGoron
- Telefonnummer: 3138064414
- E-mail: Lucy.K.McGoron@wayne.edu
-
-
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
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Parent of child ages 2-5 years old
- Report a score of 9 or higher on the Preschool Pediatric Symptoms Checklist
Exclusion Criteria:
- Does not speak/read English
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: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Intervention
This arm will go through the initial check-up of the Parenting Young Children Check-up (PYCC), receive text messages from the PYCC, and have access to modules on the PYCC website.
|
The Parenting Young Children Check-up (PYCC) is a technology-based program for parents of young children with challenging behavior.
The PYCC has three components: 1) the initial check-up, 2) text messages, and 3) the parenting program website.
|
|
Ingen indgriben: Control
This arm will only complete assessment measures.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Children's Behavioral Health Challenges
Tidsramme: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Preschool Pediatric Symptoms Checklist
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Disruptive Behavior Problems
Tidsramme: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Eyberg Behavior Checklist
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Parenting Stress
Tidsramme: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Parenting Stress Index
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Parenting
Tidsramme: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Measured with the Preschool Version of the Alabama Parenting Questionnaire
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Use of Modules on the PYCC Website
Tidsramme: From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
Number of modules used
|
From enrollment (baseline) to follow-up at 1-month and 3-months post baseline
|
|
Satisfaction with the Parenting Young Children Check-up
Tidsramme: From enrollment (baseline) to follow-up at 3-months post baseline
|
From enrollment (baseline) to follow-up at 3-months post baseline
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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. november 2025
Primær færdiggørelse (Anslået)
31. december 2026
Studieafslutning (Anslået)
31. december 2026
Datoer for studieregistrering
Først indsendt
23. juli 2026
Først indsendt, der opfyldte QC-kriterier
3. august 2026
Først opslået (Faktiske)
6. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
3. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-25-07-7947
- #R2-2025-13_PR-25-933 (Andet bevillings-/finansieringsnummer: The Children's Foundation)
Plan for individuelle deltagerdata (IPD)
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INGEN
IPD-planbeskrivelse
All participation will be confidential.
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