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Enhancing the Outcomes of a Behavioral Parent Training Intervention

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ClinicalTrials.gov Identifier: NCT02704221
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : September 17, 2018
Sponsor:
Collaborator:
University of Vermont
Information provided by (Responsible Party):
Christina Studts, University of Kentucky

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.

Condition or disease Intervention/treatment Phase
Disruptive Behavior Disorder Parenting Behavioral: Fitbit activity tracker Behavioral: Monetary rewards Behavioral: BPT training sessions Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: Enhancing the Outcomes of a Behavioral Parent Training Intervention
Study Start Date : March 1, 2016
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : September 13, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Parenting

Arm Intervention/treatment
Active Comparator: 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.
Behavioral: Fitbit activity tracker
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data

Behavioral: 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.

Experimental: 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.
Behavioral: Fitbit activity tracker
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data

Behavioral: 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.

Behavioral: 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.




Primary Outcome Measures :
  1. Proportion of participants who complete study procedures within study timeframe [ Time Frame: 14 months ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02704221


Locations
United States, Kentucky
University of Kentucky General Pediatrics Clinic
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Christina Studts
University of Vermont
Investigators
Principal Investigator: Christina Studts, PhD, LCSW University of Kentucky

Responsible Party: Christina Studts, Assistant Professor, University of Kentucky
ClinicalTrials.gov Identifier: NCT02704221     History of Changes
Other Study ID Numbers: 15-0291-P6H
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Mental Disorders
Problem Behavior
Attention Deficit and Disruptive Behavior Disorders
Behavioral Symptoms
Neurodevelopmental Disorders