Enhancing the Outcomes of a Behavioral Parent Training Intervention

NCT ID: NCT02704221

Last Updated: 2018-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-01

Study Completion Date

2018-09-13

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Disruptive Behavior Disorder Parenting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Fitbit activity tracker

Intervention Type BEHAVIORAL

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

BPT training sessions

Intervention Type BEHAVIORAL

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)

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.

Group Type EXPERIMENTAL

Fitbit activity tracker

Intervention Type BEHAVIORAL

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

Monetary rewards

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fitbit activity tracker

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Vermont

OTHER

Sponsor Role collaborator

Christina Studts

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Christina Studts

Assistant Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Christina Studts, PhD, LCSW

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Kentucky General Pediatrics Clinic

Lexington, Kentucky, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

15-0291-P6H

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Intervening Early With Neglected Children
NCT02093052 UNKNOWN PHASE1/PHASE2
Parenting Mindfully Study II
NCT05370768 ACTIVE_NOT_RECRUITING NA