Parent-Child RelationsNCT05135507
The Effective Parenting Program (EPP)
A study testing An integrated parenting intervention for families of children with developmental disabilities in people with Parent-Child Relations, run by Double S Instructonal Systems.
Trial 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'… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parent-Child Relations
- What is being tested?
- An integrated parenting intervention for families of children with developmental disabilities
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Parents of children without a developmental disability
About this study
Official title: The Effective Parenting Program (EPP): An Integrated Stress Reduction and Parenting Intervention for Families of Children With Developmental Disabilities
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.
Read the 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.
- Conditions
- Parent-Child Relations
- Being tested
- An integrated parenting intervention for families of children with developmental disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An integrated parenting intervention for families of children with developmental disabilitiesBehavioural
Deliver three training modules to parent and track program usage, psychological flexibility, parents' stress, parents mindfulness, and child behavior
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: An integrated parenting intervention for families of children with developmental disabilities |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Change from baseline child adjustment and parental self-efficacy at five weeks post
Secondary outcomes (2)
Mindful Attention Awareness Scale (MAAS)
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
Measured: Change in attention and awareness from Baseline at five weeks post
Parent Social Validity Questionnaire (PSVQ)
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
Measured: five weeks post
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2021
- Study start1 Sep 2019
- Primary completionDec 2021 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: Covid-19 - unable to recruit any participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parent-Child RelationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Within subject pre and posttest design
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Double S Instructonal Systems
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05135507
- Sponsor's protocol ID
- EPPPhaseI
- Status last verified
- Nov 2021
- First submitted
- 28 Oct 2021
- Last updated
- 26 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effective Parenting Program (EPP): An Integrated Stress Reduction and Parenting Intervention for Families of Children With Developmental Disabilities
- ClinicalTrials.gov ID
- NCT05135507
- Acronym / sponsor ID
- EPPPhaseI
- Conditions
- Parent-Child Relations
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Covid-19 - unable to recruit any participants
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Double S Instructonal SystemsIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 26 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Within subject pre and posttest design
| Arm | Type | Receives |
|---|---|---|
| An interactive stress reduction and behavioral parent training program | Experimental | Behavioral: An integrated parenting intervention for families of children with developmental disabilitiesThis 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Parents of children without a developmental disability
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| An integrated parenting intervention for families of children with developmental disabilitiesDeliver three training modules to parent and track program usage, psychological flexibility, parents' stress, parents mindfulness, and child behavior | Behavioural | An interactive stress reduction and behavioral parent training program |
Primary outcome
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
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
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
2 secondary outcomes
Mindful Attention Awareness Scale (MAAS)
Time frame: Change in attention and awareness from Baseline at five weeks post
Parent Social Validity Questionnaire (PSVQ)
Time frame: five weeks post
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing An integrated parenting intervention for families of children with developmental disabilities in people with Parent-Child Relations, run by Double S Instructonal Systems.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 26 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptance and Action Questionnaire II (AAQ-II) (time frame: Change from baseline acceptance at five weeks post). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2021.