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CompletedNCT02704221Updated Sep 17, 2018

Enhancing the Outcomes of a Behavioral Parent Training Intervention

An interventional study of Fitbit activity tracker and Monetary rewards in Disruptive Behavior Disorder and Parenting, sponsored by Christina Studts. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-09-17.

Sponsored by Christina Studts · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Disruptive Behavior Disorder
  • Parenting
03

In context

Attention Deficit and Disruptive Behavior Disorders

70 studies on the registry are indexed under Attention Deficit and Disruptive Behavior Disorders; 10 are open to participants now.

This study's enrollment of 24 is below the median of 103 across 60 interventional studies indexed under Attention Deficit and Disruptive Behavior Disorders.

Browse Attention Deficit and Disruptive Behavior Disorders studies →

Lead sponsor

Christina Studts is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
24 participants (actual)

Study arms

  • 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 · Behavioral: BPT training sessions

  • 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 · Behavioral: Monetary rewards · Behavioral: BPT training sessions

Interventions

  • BehavioralFitbit activity tracker

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

  • BehavioralMonetary 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.

  • BehavioralBPT 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.

06

What researchers measure

Primary outcomes

  1. Proportion of participants who complete study procedures within study timeframe

    Time frame: 14 months

Secondary outcomes

  1. Time required per participant to complete all instruments

    Time frame: 14 months

  2. Participant satisfaction of both control and experimental arms

    Time frame: 1 week after completion of final BPT session

  3. Step counts

    Time frame: end of 2-week screening period, and once per week for 12 weeks

  4. 2-minute step test

    Time frame: baseline and 1 week after completion of final BPT session

  5. Parenting behaviors

    Parenting Young Children instrument

    Time frame: baseline and 1 week after completion of final BPT session

  6. Child behaviors

    Child Behavior Checklist/1.5-5 instrument

    Time frame: baseline and 1 week after completion of final BPT session

  7. Parenting stress

    Parenting Stress Index/Short Form instrument

    Time frame: baseline and 1 week after completion of final BPT session

  8. Parenting sense of competence

    Parenting Sense of Competence Scale

    Time frame: baseline and 1 week after completion of final BPT session

  9. Parent depression

    Beck Depression Inventory-II

    Time frame: baseline and 1 week after completion of final BPT session

  10. Self-reported physical activity level

    Godin Leisure-Time Exercise Questionnaire

    Time frame: baseline and 1 week after completion of final BPT session

  11. Visual Analog Scale-Fatigue

    Time frame: baseline and 1 week after completion of final BPT session

07

Study locations

1 site
  • University of Kentucky General Pediatrics Clinic
    Lexington, Kentucky 40536, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Mar 2016, a primary completion of Oct 2017 and a completion of Sep 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 4, 2016
First posted
Mar 9, 2016
Start
Mar 1, 2016
Primary completionActual
Oct 1, 2017
CompletionActual
Sep 13, 2018
Last update
Sep 17, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 17, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02704221
Lead sponsor
Christina Studts
Responsible party
Christina Studts (Assistant Professor, University of Kentucky) — Sponsor-investigator
First posted
Mar 9, 2016
Start date
Mar 1, 2016
Primary completion
Oct 1, 2017
Completion
Sep 13, 2018
Last update
Sep 17, 2018

Study contacts

Christina Studts, PhD, LCSW
principal investigator · University of Kentucky

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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