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Enhancing the Outcomes of a Behavioral Parent Training Intervention

Primary Purpose

Disruptive Behavior Disorder, Parenting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitbit activity tracker
Monetary rewards
BPT training sessions
Sponsored by
Christina Studts
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Disruptive Behavior Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Kentucky General Pediatrics Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Behavioral Parent Training (BPT)

BPT + Contingency Management (BPT+CM)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Proportion of participants who complete study procedures within study timeframe

Secondary Outcome Measures

Time required per participant to complete all instruments
Participant satisfaction of both control and experimental arms
Step counts
2-minute step test
Parenting behaviors
Parenting Young Children instrument
Child behaviors
Child Behavior Checklist/1.5-5 instrument
Parenting stress
Parenting Stress Index/Short Form instrument
Parenting sense of competence
Parenting Sense of Competence Scale
Parent depression
Beck Depression Inventory-II
Self-reported physical activity level
Godin Leisure-Time Exercise Questionnaire
Visual Analog Scale-Fatigue

Full Information

First Posted
March 4, 2016
Last Updated
September 13, 2018
Sponsor
Christina Studts
Collaborators
University of Vermont
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1. Study Identification

Unique Protocol Identification Number
NCT02704221
Brief Title
Enhancing the Outcomes of a Behavioral Parent Training Intervention
Official Title
Enhancing the Outcomes of a Behavioral Parent Training Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
March 1, 2016 (undefined)
Primary Completion Date
October 1, 2017 (Actual)
Study Completion Date
September 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Christina Studts
Collaborators
University of Vermont

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disruptive Behavior Disorder, Parenting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Behavioral Parent Training (BPT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
BPT + Contingency Management (BPT+CM)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Fitbit activity tracker
Intervention Description
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Intervention Type
Behavioral
Intervention Name(s)
Monetary rewards
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
BPT training sessions
Intervention Description
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 Measure Information:
Title
Proportion of participants who complete study procedures within study timeframe
Time Frame
14 months
Secondary Outcome Measure Information:
Title
Time required per participant to complete all instruments
Time Frame
14 months
Title
Participant satisfaction of both control and experimental arms
Time Frame
1 week after completion of final BPT session
Title
Step counts
Time Frame
end of 2-week screening period, and once per week for 12 weeks
Title
2-minute step test
Time Frame
baseline and 1 week after completion of final BPT session
Title
Parenting behaviors
Description
Parenting Young Children instrument
Time Frame
baseline and 1 week after completion of final BPT session
Title
Child behaviors
Description
Child Behavior Checklist/1.5-5 instrument
Time Frame
baseline and 1 week after completion of final BPT session
Title
Parenting stress
Description
Parenting Stress Index/Short Form instrument
Time Frame
baseline and 1 week after completion of final BPT session
Title
Parenting sense of competence
Description
Parenting Sense of Competence Scale
Time Frame
baseline and 1 week after completion of final BPT session
Title
Parent depression
Description
Beck Depression Inventory-II
Time Frame
baseline and 1 week after completion of final BPT session
Title
Self-reported physical activity level
Description
Godin Leisure-Time Exercise Questionnaire
Time Frame
baseline and 1 week after completion of final BPT session
Title
Visual Analog Scale-Fatigue
Time Frame
baseline and 1 week after completion of final BPT session

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina Studts, PhD, LCSW
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky General Pediatrics Clinic
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Enhancing the Outcomes of a Behavioral Parent Training Intervention

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