Enhancing the Outcomes of a Behavioral Parent Training Intervention

Parenting Clinical Trial

Official title:

Enhancing the Outcomes of a Behavioral Parent Training Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704221
• Other study ID #: 15-0291-P6H
• Status: Completed
• Phase: N/A
• Start date: March 1, 2016
• Est. completion date: September 13, 2018

Study information

• Verified date: September 2018
• Source: University of Kentucky
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: September 13, 2018
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Attention Deficit and Disruptive Behavior Disorders
• Disruptive Behavior Disorder
• Mental Disorders
• Parenting
• Problem Behavior

Intervention

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

Locations

Country	Name	City	State
United States	University of Kentucky General Pediatrics Clinic	Lexington	Kentucky

Sponsors (2)

Lead Sponsor	Collaborator
Christina Studts	University of Vermont

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants who complete study procedures within study timeframe		14 months
Secondary	Time required per participant to complete all instruments		14 months
Secondary	Participant satisfaction of both control and experimental arms		1 week after completion of final BPT session
Secondary	Step counts		end of 2-week screening period, and once per week for 12 weeks
Secondary	2-minute step test		baseline and 1 week after completion of final BPT session
Secondary	Parenting behaviors	Parenting Young Children instrument	baseline and 1 week after completion of final BPT session
Secondary	Child behaviors	Child Behavior Checklist/1.5-5 instrument	baseline and 1 week after completion of final BPT session
Secondary	Parenting stress	Parenting Stress Index/Short Form instrument	baseline and 1 week after completion of final BPT session
Secondary	Parenting sense of competence	Parenting Sense of Competence Scale	baseline and 1 week after completion of final BPT session
Secondary	Parent depression	Beck Depression Inventory-II	baseline and 1 week after completion of final BPT session
Secondary	Self-reported physical activity level	Godin Leisure-Time Exercise Questionnaire	baseline and 1 week after completion of final BPT session
Secondary	Visual Analog Scale-Fatigue		baseline and 1 week after completion of final BPT session