Clinical trial NCT05135507: The Effective Parenting Program (EPP)
Official title: The Effective Parenting Program (EPP): An Integrated Stress Reduction and Parenting Intervention for Families of Children With Developmental Disabilities
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Parent-Child Relations
Lead sponsor: Double S Instructonal Systems
Sponsor class: INDUSTRY
First posted: 2021-11-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Within subject pre and posttest design
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Acceptance and Action Questionnaire II (AAQ-II)
timeFrame: Change from baseline acceptance at five weeks post
measure: Parental Stress Scale
timeFrame: Change from baseline parental stress at five weeks post
measure: Child Adjustment and Parent Efficacy Scale(CAPES)
timeFrame: Change from baseline child adjustment and parental self-efficacy at five weeks post
Secondary outcomes:
measure: Mindful Attention Awareness Scale (MAAS)
timeFrame: Change in attention and awareness from Baseline at five weeks post
measure: Parent Social Validity Questionnaire (PSVQ)
timeFrame: five weeks post
Other outcomes:
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