Enhancing the Outcomes of a Behavioral Parent Training Intervention

Not Applicable

Completed

• Conditions: Disruptive Behavior Disorder; Parenting
• Interventions: Behavioral: Fitbit activity tracker; Behavioral: Monetary rewards; Behavioral: BPT training sessions

• Registration Number: NCT02704221
• Lead Sponsor: Christina Studts

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.

Study Timeline

• Study Start: 2016-03-01
• Study First Submitted: 2016-03-04
• Study First Submitted QC: 2016-03-08
• Study First Posted: 2016-03-09
• Primary Completion: 2017-10-01
• Status Verified: 2018-09
• Study Completion: 2018-09-13
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Behavioral Parent Training (BPT)	Fitbit activity tracker	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.
BPT + Contingency Management (BPT+CM)	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.
Behavioral Parent Training (BPT)	BPT training sessions	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.
BPT + Contingency Management (BPT+CM)	Fitbit activity tracker	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.
BPT + Contingency Management (BPT+CM)	Monetary rewards	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.

Primary Outcome Measures

Name	Time	Method
Proportion of participants who complete study procedures within study timeframe	14 months

Secondary Outcome Measures

Name	Time	Method
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	Parenting Young Children instrument
Child behaviors	baseline and 1 week after completion of final BPT session	Child Behavior Checklist/1.5-5 instrument
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 Stress Index/Short Form instrument
Parenting sense of competence	baseline and 1 week after completion of final BPT session	Parenting Sense of Competence Scale
Parent depression	baseline and 1 week after completion of final BPT session	Beck Depression Inventory-II
Self-reported physical activity level	baseline and 1 week after completion of final BPT session	Godin Leisure-Time Exercise Questionnaire
Visual Analog Scale-Fatigue	baseline and 1 week after completion of final BPT session

Trial Locations

Locations (1)

University of Kentucky General Pediatrics Clinic; 🇺🇸 Lexington, Kentucky, United States