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Enhancing the Outcomes of a Behavioral Parent Training Intervention

13. september 2018 opdateret af: Christina Studts
This study is a feasibility trial, testing the hypothesis that among sedentary mothers of behaviorally at-risk preschool-aged children, those who receive behavioral parent training (BPT) programs and concurrently increase their physical activity levels will demonstrate improved parenting and child behavior outcomes compared to those who receive BPT but remain sedentary.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The investigators will randomly assign 20 participants to two groups: behavioral parent training plus contingency management to increase steps (BPT+CM) or behavioral parent training alone (BPT). Contingency management procedures will involve monetary rewards for meeting weekly step-count goals.

The specific aims of the proposed project are to: 1) assess the feasibility of the study design and procedures, 2) assess the acceptability of the BPT+CM condition to participants, and 3) determine whether a signal of an effect of increased physical activity exists (via preliminary comparisons of measures of fatigue, perceived energy, parenting behaviors, parenting sense of competence, parenting stress, and child behavior ratings between participants in the two conditions).

This innovative pilot study will prepare us for a fully powered trial to test the efficacy of this approach.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

24

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
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40536
        • University of Kentucky General Pediatrics Clinic

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

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Female
  • Age 18 years or older
  • Custodial caregiver of a child aged 2-5 years who lives full-time in the caregiver's home
  • Reports that her child has behavioral problems
  • Never or rarely engages in regular physical activity
  • Able to understand, speak, and read English

Exclusion Criteria:

  • The child has been diagnosed with a severe developmental condition (e.g., extreme developmental delay, severe autism, debilitating neurological conditions)
  • Participant reports a condition that may contraindicate physical activity (e.g., asthma)

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

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

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Behavioral Parent Training (BPT)
The control group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks and 2) attend 12 weekly BPT training sessions.
Adfærdsmæssigt: Fitbit activity tracker
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Adfærdsmæssigt: BPT training sessions
Complete 12 BPT training sessions delivered by supervised clinical child psychology doctoral students, with each session lasting approximately 60 minutes. The BPT is based upon the existing, evidence-based Everyday Parenting intervention.
Eksperimentel: BPT + Contingency Management (BPT+CM)
The experimental group will include 10 participants who will 1) wear Fitbit activity trackers daily for 12 weeks, 2) attend 12 weekly BPT training sessions, and 3) receive monetary rewards for achieving weekly step-count goals.
Adfærdsmæssigt: Fitbit activity tracker
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Adfærdsmæssigt: BPT training sessions
Complete 12 BPT training sessions delivered by supervised clinical child psychology doctoral students, with each session lasting approximately 60 minutes. The BPT is based upon the existing, evidence-based Everyday Parenting intervention.
Adfærdsmæssigt: Monetary rewards
Set weekly step-count goals based on the previous week's performance and receive monetary rewards for meeting the goals. The schedule of rewards increases as step-count goals increase.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Proportion of participants who complete study procedures within study timeframe
Tidsramme: 14 months
14 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time required per participant to complete all instruments
Tidsramme: 14 months
14 months
Participant satisfaction of both control and experimental arms
Tidsramme: 1 week after completion of final BPT session
1 week after completion of final BPT session
Step counts
Tidsramme: end of 2-week screening period, and once per week for 12 weeks
end of 2-week screening period, and once per week for 12 weeks
2-minute step test
Tidsramme: baseline and 1 week after completion of final BPT session
baseline and 1 week after completion of final BPT session
Parenting behaviors
Tidsramme: baseline and 1 week after completion of final BPT session
Parenting Young Children instrument
baseline and 1 week after completion of final BPT session
Child behaviors
Tidsramme: baseline and 1 week after completion of final BPT session
Child Behavior Checklist/1.5-5 instrument
baseline and 1 week after completion of final BPT session
Parenting stress
Tidsramme: baseline and 1 week after completion of final BPT session
Parenting Stress Index/Short Form instrument
baseline and 1 week after completion of final BPT session
Parenting sense of competence
Tidsramme: baseline and 1 week after completion of final BPT session
Parenting Sense of Competence Scale
baseline and 1 week after completion of final BPT session
Parent depression
Tidsramme: baseline and 1 week after completion of final BPT session
Beck Depression Inventory-II
baseline and 1 week after completion of final BPT session
Self-reported physical activity level
Tidsramme: baseline and 1 week after completion of final BPT session
Godin Leisure-Time Exercise Questionnaire
baseline and 1 week after completion of final BPT session
Visual Analog Scale-Fatigue
Tidsramme: baseline and 1 week after completion of final BPT session
baseline and 1 week after completion of final BPT session

Samarbejdspartnere og efterforskere

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

Sponsor

Christina Studts

Samarbejdspartnere

University of Vermont

Efterforskere

  • Ledende efterforsker: Christina Studts, PhD, LCSW, University Of Kentucky

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. marts 2016

Primær færdiggørelse (Faktiske)

1. oktober 2017

Studieafslutning (Faktiske)

13. september 2018

Datoer for studieregistrering

Først indsendt

4. marts 2016

Først indsendt, der opfyldte QC-kriterier

8. marts 2016

Først opslået (Skøn)

9. marts 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

17. september 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. september 2018

Sidst verificeret

1. september 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 15-0291-P6H

Plan for individuelle deltagerdata (IPD)

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