NCT05135507

Brief Summary

The Phase I objective is to determine the feasibility of the EPP program by examining user responses to the first three units of EPP's nine interactive training modules. This feasibility evaluation will track and analyze individual program usage and examine changes in parents' psychological flexibility, parents' stress, parenting self-efficacy, parents' mindfulness and child behavior in a within subject pretest and posttest design with 50 parents of children who have DD. Qualifying parents will complete a baseline assessment and then be directed to our online learning platform to complete the interactive learning activities. This test of the Phase I prototype is intended to approximate the conditions under which the complete product will be marketed and used.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2019

Longer than P75 for not_applicable

Status
withdrawn

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

September 1, 2019

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 28, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 26, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

November 26, 2021

Status Verified

November 1, 2021

Enrollment Period

2.3 years

First QC Date

October 28, 2021

Last Update Submit

November 22, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Acceptance and Action Questionnaire II (AAQ-II)

    Measures the extent to which individuals were able to experience upsetting or difficult thoughts, feelings and emotions without trying to suppress or avoid them and to take valued action, even in the midst of difficult internal experiences.It is comprised of 7 items rating scale with 1=never true and 7= always true

    Change from baseline acceptance at five weeks post

  • Parental Stress Scale

    The PSS consists of 18 items that measure the levels of stress parents experience as a result of having children. Parents respond by indicating the extent that they agree or disagree with each statement on a 5 point scale.5 point scale; strongly disagree, disagree, undecided, agree, strongly agree

    Change from baseline parental stress at five weeks post

  • Child Adjustment and Parent Efficacy Scale(CAPES)

    the CAPES consists of a 30-item intensity scale with two subscales measuring child behavior problems, child prosocial behavior and emotional maladjustment and a 20-item self-efficacy scale assessing parents parent's self-efficacy in handling specific child problem behaviors.4 point rating scale with 0=not at all and 3=very much

    Change from baseline child adjustment and parental self-efficacy at five weeks post

Secondary Outcomes (2)

  • Mindful Attention Awareness Scale (MAAS)

    Change in attention and awareness from Baseline at five weeks post

  • Parent Social Validity Questionnaire (PSVQ)

    five weeks post

Study Arms (1)

An interactive stress reduction and behavioral parent training program

EXPERIMENTAL

This feasibility evaluation will track and analyze individual program usage and examine changes in parents' psychological flexibility, parents' stress, parenting self-efficacy, parents' mindfulness and child behavior in a within subject pretest and posttest design with 50 parents of children who have DD

Behavioral: An integrated parenting intervention for families of children with developmental disabilities

Interventions

Deliver three training modules to parent and track program usage, psychological flexibility, parents' stress, parents mindfulness, and child behavior

An interactive stress reduction and behavioral parent training program

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parents of children with developmental disabilities having a child with Developmental Disabilities who lives at home (50% of parents will have a child with autism and 50% will have a child with intellectual disabilities,
  • Must have access to a phone that can receive text messages and an Internet connection,
  • Stress levels being elevated (i.e., greater than .5 standard deviations above the normative data mean score) on a 12 item Parental distress sub scale of the Parenting Stress Index- short form.

You may not qualify if:

  • Parents of children without a developmental disability

Contact the study team to confirm eligibility.

Sponsors & Collaborators

0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Within subject pre and posttest design
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2021

First Posted

November 26, 2021

Study Start

September 1, 2019

Primary Completion

December 1, 2021

Study Completion

December 1, 2022

Last Updated

November 26, 2021

Record last verified: 2021-11