- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05135507
The Effective Parenting Program (EPP)
The Effective Parenting Program (EPP): An Integrated Stress Reduction and Parenting Intervention for Families of Children With Developmental Disabilities
Study Overview
Status
Conditions
Detailed Description
Parents who have children with developmental disabilities (DD) commonly experience high levels of stress related to child behavior problems and contextual issues related to the child's disability that can have a detrimental effect on their parenting. Current stress management programs for this population of parents often do not lead to a reduction in children's behavior problems and Behavioral Parent Training programs (BPT) do not always lead to a reduction in stress. Interventions that combine the two approaches are more effective, providing substantial benefits to both parent and child. The central goal of this project is to create an online, interactive stress reduction and BPT program: The Effective Parenting Program (EPP): An Integrated Parenting Intervention for Families of Children with Developmental Disabilities. The investigators propose three Specific Aims with the primary aims of reducing parents' stress and strengthening parents' parenting efficacy and psychological flexibility. The investigators secondary aims are designed to answer questions regarding (a) the influence of changes in parents' efficacy and psychological flexibility on child behavior and (b) the role of parents' attention to and awareness of present moment experiences. This work is significant because it will provide resources for an underserved population - parents of children with DD -- who experience frequent stress with the challenges of raising a child with DD and who may lack basic behavioral parenting skills. Moreover, the proposed program has the potential to broadly impact the way supports are delivered to parents of children with DD by adding an integrated, efficacious intervention that overcomes common barriers to parental participation (time, finances, and availability). From a public health perspective, this approach is ideally structured to meet the needs of this population of parents who are in need of easy to implement and cost effective support and training.
Upon completion in Phase II, parents will have access to a complete EPP program, designed to help parents cope with stress more effectively and strengthen their behavioral parenting skills. The program will provide parents with engaging, interactive content, including: tools for monitoring progress, text prompts and incentives to motivate behavior change, a mechanism for the sharing of social support, guidance in setting effective value-based goals, strategies for reducing stress, and training in evidence-based parenting skills. The EPP program will be available on a mobile website that can be accessed by smart phones, tablets and computers and will provide realistic situational videos vignettes, workbook exercises and a discussion forum to help parents deal effectively with stress and challenging behaviors. In Phase I of this project, the investigators will determine the feasibility of the program by examining primary and secondary outcomes related to a prototype of the EEP program.
Study Type
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- Parents of children without a developmental disability
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: An interactive stress reduction and behavioral parent training program
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
|
Deliver three training modules to parent and track program usage, psychological flexibility, parents' stress, parents mindfulness, and child behavior
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Acceptance and Action Questionnaire II (AAQ-II)
Time Frame: Change from baseline acceptance at five weeks post
|
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
Time Frame: Change from baseline parental stress at five weeks post
|
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)
Time Frame: Change from baseline child adjustment and parental self-efficacy at five weeks post
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mindful Attention Awareness Scale (MAAS)
Time Frame: Change in attention and awareness from Baseline at five weeks post
|
This 18 item instrument measures participant's tendency to be attentive to and aware of present moment experiences in daily life.6 point scale 1= almost always and 6 = almost never |
Change in attention and awareness from Baseline at five weeks post
|
|
Parent Social Validity Questionnaire (PSVQ)
Time Frame: five weeks post
|
This 6-item survey will assess parent perceptions of the materials and the extent to which they have been practicing the techniques they had learned.
Parents will indicate the extent to which they agree with each item on a 7-point Likert scale.
The items are rated on a five point scale -- 1=strongly agree to 5= strongly disagree.6
items consisting of a 5 item rating scales items 1-5 with 1=none and 6 = very much And item 6 asks them to check of a list of 5 barriers to doing the program
|
five weeks post
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- EPPPhaseI
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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