Clinical trial NCT02704221: Enhancing the Outcomes of a Behavioral Parent Training Intervention
Official title: Enhancing the Outcomes of a Behavioral Parent Training Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disruptive Behavior Disorder
Parenting
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: University of Vermont
First posted: 2016-03-09
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of participants who complete study procedures within study timeframe
timeFrame: 14 months
Secondary outcomes:
measure: Time required per participant to complete all instruments
timeFrame: 14 months
measure: Participant satisfaction of both control and experimental arms
timeFrame: 1 week after completion of final BPT session
measure: Step counts
timeFrame: end of 2-week screening period, and once per week for 12 weeks
measure: 2-minute step test
timeFrame: baseline and 1 week after completion of final BPT session
measure: Parenting behaviors
timeFrame: baseline and 1 week after completion of final BPT session
measure: Child behaviors
timeFrame: baseline and 1 week after completion of final BPT session
measure: Parenting stress
timeFrame: baseline and 1 week after completion of final BPT session
measure: Parenting sense of competence
timeFrame: baseline and 1 week after completion of final BPT session
measure: Parent depression
timeFrame: baseline and 1 week after completion of final BPT session
measure: Self-reported physical activity level
timeFrame: baseline and 1 week after completion of final BPT session
measure: Visual Analog Scale-Fatigue
timeFrame: baseline and 1 week after completion of final BPT session
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky General Pediatrics Clinic
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Christina Studts, PhD, LCSW
role: PRINCIPAL_INVESTIGATOR
References: