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OpenTrials
Completed

NCT Number: NCT02704221

Enhancing the Outcomes of a Behavioral Parent Training Intervention

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Kentucky General Pediatrics Clinic

Lexington, Kentucky, 40536, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fitbit activity tracker

Behavioral

Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data

Monetary rewards

Behavioral

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.

BPT training sessions

Behavioral

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.

Primary outcomes

  1. Proportion of participants who complete study procedures within study timeframe

    Time frame: 14 months

Secondary outcomes

  1. Time required per participant to complete all instruments

    Time frame: 14 months

  2. Participant satisfaction of both control and experimental arms

    Time frame: 1 week after completion of final BPT session

  3. Step counts

    Time frame: end of 2-week screening period, and once per week for 12 weeks

  4. 2-minute step test

    Time frame: baseline and 1 week after completion of final BPT session

  5. Parenting behaviors

    Time frame: baseline and 1 week after completion of final BPT session

    Parenting Young Children instrument

  6. Child behaviors

    Time frame: baseline and 1 week after completion of final BPT session

    Child Behavior Checklist/1.5-5 instrument

  7. Parenting stress

    Time frame: baseline and 1 week after completion of final BPT session

    Parenting Stress Index/Short Form instrument

  8. Parenting sense of competence

    Time frame: baseline and 1 week after completion of final BPT session

    Parenting Sense of Competence Scale

  9. Parent depression

    Time frame: baseline and 1 week after completion of final BPT session

    Beck Depression Inventory-II

  10. Self-reported physical activity level

    Time frame: baseline and 1 week after completion of final BPT session

    Godin Leisure-Time Exercise Questionnaire

  11. Visual Analog Scale-Fatigue

    Time frame: baseline and 1 week after completion of final BPT session

Sponsors and collaborators

Lead sponsor

Christina Studts

Other

Collaborators

  • University of Vermont

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Mar 9, 2016
Registry last updated
Sep 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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