Enhancing the Outcomes of a Behavioral Parent Training Intervention
13 september 2018 uppdaterad av: 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
24
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40536
- University of Kentucky General Pediatrics Clinic
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Ja
Kön som är behöriga för studier
Kvinna
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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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.
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Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
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.
|
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Experimentell: 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.
|
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
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.
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
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Proportion of participants who complete study procedures within study timeframe
Tidsram: 14 months
|
14 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time required per participant to complete all instruments
Tidsram: 14 months
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14 months
|
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Participant satisfaction of both control and experimental arms
Tidsram: 1 week after completion of final BPT session
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1 week after completion of final BPT session
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Step counts
Tidsram: end of 2-week screening period, and once per week for 12 weeks
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end of 2-week screening period, and once per week for 12 weeks
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2-minute step test
Tidsram: baseline and 1 week after completion of final BPT session
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baseline and 1 week after completion of final BPT session
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|
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Parenting behaviors
Tidsram: baseline and 1 week after completion of final BPT session
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Parenting Young Children instrument
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baseline and 1 week after completion of final BPT session
|
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Child behaviors
Tidsram: baseline and 1 week after completion of final BPT session
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Child Behavior Checklist/1.5-5
instrument
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baseline and 1 week after completion of final BPT session
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Parenting stress
Tidsram: baseline and 1 week after completion of final BPT session
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Parenting Stress Index/Short Form instrument
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baseline and 1 week after completion of final BPT session
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Parenting sense of competence
Tidsram: baseline and 1 week after completion of final BPT session
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Parenting Sense of Competence Scale
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baseline and 1 week after completion of final BPT session
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Parent depression
Tidsram: baseline and 1 week after completion of final BPT session
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Beck Depression Inventory-II
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baseline and 1 week after completion of final BPT session
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Self-reported physical activity level
Tidsram: baseline and 1 week after completion of final BPT session
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Godin Leisure-Time Exercise Questionnaire
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baseline and 1 week after completion of final BPT session
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Visual Analog Scale-Fatigue
Tidsram: baseline and 1 week after completion of final BPT session
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baseline and 1 week after completion of final BPT session
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Christina Studts, PhD, LCSW, University of Kentucky
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 mars 2016
Primärt slutförande (Faktisk)
1 oktober 2017
Avslutad studie (Faktisk)
13 september 2018
Studieregistreringsdatum
Först inskickad
4 mars 2016
Först inskickad som uppfyllde QC-kriterierna
8 mars 2016
Första postat (Uppskatta)
9 mars 2016
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
17 september 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
13 september 2018
Senast verifierad
1 september 2018
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 15-0291-P6H
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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