NCT02704221

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2016

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 13, 2018

Completed
Last Updated

September 17, 2018

Status Verified

September 1, 2018

Enrollment Period

1.6 years

First QC Date

March 4, 2016

Last Update Submit

September 13, 2018

Conditions

Disruptive Behavior DisorderParenting

Outcome Measures

Primary Outcomes (1)

  • Proportion of participants who complete study procedures within study timeframe

    14 months

Secondary Outcomes (11)

  • 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

    baseline and 1 week after completion of final BPT session

  • +6 more secondary outcomes

Study Arms (2)

Behavioral Parent Training (BPT)

ACTIVE COMPARATOR

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 trackerBehavioral: BPT training sessions

BPT + Contingency Management (BPT+CM)

EXPERIMENTAL

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 trackerBehavioral: Monetary rewardsBehavioral: BPT training sessions

Interventions

Fitbit activity trackerBEHAVIORAL

Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data

BPT + Contingency Management (BPT+CM)Behavioral Parent Training (BPT)
Monetary rewardsBEHAVIORAL

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 + Contingency Management (BPT+CM)
BPT training sessionsBEHAVIORAL

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.

BPT + Contingency Management (BPT+CM)Behavioral Parent Training (BPT)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Kentucky General Pediatrics Clinic

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Attention Deficit and Disruptive Behavior Disorders

Condition Hierarchy (Ancestors)

Neurodevelopmental DisordersMental Disorders

Study Officials

  • Christina Studts, PhD, LCSW

    University of Kentucky

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 4, 2016

First Posted

March 9, 2016

Study Start

March 1, 2016

Primary Completion

October 1, 2017

Study Completion

September 13, 2018

Last Updated

September 17, 2018

Record last verified: 2018-09

Data Sharing

IPD Sharing
Will not share

Locations

US(1)