Disruptive Behavior DisorderNCT02704221
Enhancing the Outcomes of a Behavioral Parent Training Intervention
A study testing Fitbit activity tracker, Monetary rewards and BPT training sessions in people with Disruptive Behavior Disorder and Parenting, run by Christina Studts at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disruptive Behavior Disorder, Parenting
- What is being tested?
- Fitbit activity tracker, Monetary rewards and BPT training sessions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2016to 13 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kentucky General Pediatrics Clinic
Lexington, Kentucky, 40536
About this study
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.
- Conditions
- Disruptive Behavior Disorder, Parenting
- Being tested
- Fitbit activity tracker, Monetary rewards, BPT training sessions
- Medical subject headings
- Attention Deficit and Disruptive Behavior Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitbit activity trackerBehavioural
Wear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data
Monetary rewardsBehavioural
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 sessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Fitbit activity tracker; Behavioral: 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. Receives: Behavioral: Fitbit activity tracker; Behavioral: Monetary rewards; Behavioral: BPT training sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants who complete study procedures within study timeframe
Measured: 14 months
Secondary outcomes (11)
Time required per participant to complete all instruments
Measured: 14 months
Participant satisfaction of both control and experimental arms
Measured: 1 week after completion of final BPT session
Step counts
Measured: end of 2-week screening period, and once per week for 12 weeks
2-minute step test
Measured: baseline and 1 week after completion of final BPT session
Parenting behaviors
Parenting Young Children instrument
Measured: baseline and 1 week after completion of final BPT session
Child behaviors
Child Behavior Checklist/1.5-5 instrument
Measured: baseline and 1 week after completion of final BPT session
Parenting stress
Parenting Stress Index/Short Form instrument
Measured: baseline and 1 week after completion of final BPT session
Parenting sense of competence
Parenting Sense of Competence Scale
Measured: baseline and 1 week after completion of final BPT session
Parent depression
Beck Depression Inventory-II
Measured: baseline and 1 week after completion of final BPT session
Self-reported physical activity level
Godin Leisure-Time Exercise Questionnaire
Measured: baseline and 1 week after completion of final BPT session
Visual Analog Scale-Fatigue
Measured: baseline and 1 week after completion of final BPT session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2016 (estimated)
- Study start1 Mar 2016
- Primary completion1 Oct 2017
- Study completion13 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disruptive Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christina Studts
- Sponsor type
- University, hospital or other
- Collaborators
- University of Vermont
- Responsible party
- Sponsor-investigator, Christina Studts, University of Kentucky
- Investigators
- Christina Studts, PhD, LCSW, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02704221
- Sponsor's protocol ID
- 15-0291-P6H
- Status last verified
- Sep 2018
- First submitted
- 4 Mar 2016
- Last updated
- 17 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing the Outcomes of a Behavioral Parent Training Intervention
- ClinicalTrials.gov ID
- NCT02704221
- Acronym / sponsor ID
- 15-0291-P6H
- Conditions
- Disruptive Behavior Disorder, Parenting
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Christina StudtsUniversity, hospital or other
- Collaborators
- University of Vermont
- Study start
- 1 Mar 2016
- Primary completion
- 1 Oct 2017 (actual)
- Study completion
- 13 Sep 2018 (actual)
- First posted
- 9 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Parent Training (BPT) | Active comparator | Behavioral: Fitbit activity tracker, Behavioral: BPT training sessionsThe 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) | Experimental | Behavioral: Fitbit activity tracker, Behavioral: Monetary rewards, Behavioral: BPT training sessionsThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitbit activity trackerWear a Fitbit daily for 12 weeks and meet with a research assistant once per week to download data | Behavioural | BPT + Contingency Management (BPT+CM), Behavioral Parent Training (BPT) |
| Monetary rewardsSet 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. | Behavioural | BPT + Contingency Management (BPT+CM) |
| BPT training sessionsComplete 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. | Behavioural | BPT + Contingency Management (BPT+CM), Behavioral Parent Training (BPT) |
Primary outcome
Proportion of participants who complete study procedures within study timeframe
Time frame: 14 months
11 secondary outcomes
Time required per participant to complete all instruments
Time frame: 14 months
Participant satisfaction of both control and experimental arms
Time frame: 1 week after completion of final BPT session
Step counts
Time frame: end of 2-week screening period, and once per week for 12 weeks
2-minute step test
Time frame: baseline and 1 week after completion of final BPT session
Parenting behaviors
Time frame: baseline and 1 week after completion of final BPT session
Child behaviors
Time frame: baseline and 1 week after completion of final BPT session
Parenting stress
Time frame: baseline and 1 week after completion of final BPT session
Parenting sense of competence
Time frame: baseline and 1 week after completion of final BPT session
Parent depression
Time frame: baseline and 1 week after completion of final BPT session
Self-reported physical activity level
Time frame: baseline and 1 week after completion of final BPT session
Visual Analog Scale-Fatigue
Time frame: baseline and 1 week after completion of final BPT session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christina Studts, PhD, LCSW principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitbit activity tracker, Monetary rewards and BPT training sessions in people with Disruptive Behavior Disorder and Parenting, run by Christina Studts at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants who complete study procedures within study timeframe (time frame: 14 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2018.