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Clinical Trials/NCT02704221
NCT02704221
Completed
Not Applicable

Enhancing the Outcomes of a Behavioral Parent Training Intervention

Christina Studts1 site in 1 country24 target enrollmentMarch 1, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Disruptive Behavior Disorder
Sponsor
Christina Studts
Enrollment
24
Locations
1
Primary Endpoint
Proportion of participants who complete study procedures within study timeframe
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
March 1, 2016
End Date
September 13, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Christina Studts
Responsible Party
Sponsor Investigator
Principal Investigator

Christina Studts

Assistant Professor

University of Kentucky

Eligibility Criteria

Inclusion Criteria

  • 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)

Outcomes

Primary Outcomes

Proportion of participants who complete study procedures within study timeframe

Time Frame: 14 months

Secondary Outcomes

  • Participant satisfaction of both control and experimental arms(1 week after completion of final BPT session)
  • Step counts(end of 2-week screening period, and once per week for 12 weeks)
  • Parenting behaviors(baseline and 1 week after completion of final BPT session)
  • Child behaviors(baseline and 1 week after completion of final BPT session)
  • Time required per participant to complete all instruments(14 months)
  • 2-minute step test(baseline and 1 week after completion of final BPT session)
  • Parenting stress(baseline and 1 week after completion of final BPT session)
  • Parenting sense of competence(baseline and 1 week after completion of final BPT session)
  • Parent depression(baseline and 1 week after completion of final BPT session)
  • Self-reported physical activity level(baseline and 1 week after completion of final BPT session)
  • Visual Analog Scale-Fatigue(baseline and 1 week after completion of final BPT session)

Study Sites (1)

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