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.

Study Overview

• Status: Completed
• Conditions: Parenting; Disruptive Behavior Disorder
• Intervention / Treatment: Behavioral: Fitbit activity tracker; Behavioral: BPT training sessions; Behavioral: Monetary rewards

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
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • University of Kentucky General Pediatrics Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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: 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.; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of participants who complete study procedures within study timeframe	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time required per participant to complete all instruments		14 months
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
2-minute step test		baseline and 1 week after completion of final BPT session
Parenting behaviors	Parenting Young Children instrument	baseline and 1 week after completion of final BPT session
Child behaviors	Child Behavior Checklist/1.5-5 instrument	baseline and 1 week after completion of final BPT session
Parenting stress	Parenting Stress Index/Short Form instrument	baseline and 1 week after completion of final BPT session
Parenting sense of competence	Parenting Sense of Competence Scale	baseline and 1 week after completion of final BPT session
Parent depression	Beck Depression Inventory-II	baseline and 1 week after completion of final BPT session
Self-reported physical activity level	Godin Leisure-Time Exercise Questionnaire	baseline and 1 week after completion of final BPT session
Visual Analog Scale-Fatigue		baseline and 1 week after completion of final BPT session

Collaborators and Investigators

• Sponsor: Christina Studts
• Collaborators: University of Vermont
• Investigators: Principal Investigator: Christina Studts, PhD, LCSW, University of Kentucky

Study record dates

Study Major Dates

• Study Start: March 1, 2016
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): September 13, 2018

Study Registration Dates

• First Submitted: March 4, 2016
• First Submitted That Met QC Criteria: March 8, 2016
• First Posted (Estimate): March 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Neurodevelopmental Disorders; Problem Behavior; Mental Disorders; Attention Deficit and Disruptive Behavior Disorders
• Other Study ID Numbers: 15-0291-P6H

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No