ParentsNCT04107792
Parental Sense of Competence Workshops for Parents of Children With Sensory Processing Issues
A study testing parental sense of competence workshop in people with Parents, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
Trial summary
The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parents
- What is being tested?
- parental sense of competence workshop
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteCanada
- Study dates
- 31 Jan 2020to 30 Sep 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Parents of children with Sensory Processing Issues
- On the waitlist for a neurodevelopmental diagnostic assessment at the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital
- At least 18 years of age or older
- Target child(ren) with SPIs must be between the ages of 0-17 years (which is the age restriction of the Parental Sense of Comptence scale)
- The child(ren)'s scheduled neurodevelopmental diagnostic assessment date must be after their final completion of the Parental Sense of Competence Scale (two weeks following workshop attendance) to control for any external influence that a formal diagnosis may have on participants' Parental Sense of Competence
- Basic English comprehension reading and writing skills
- Access to the internet
Who cannot join
- Previously attended a parent education workshop or intervention targeting Sensory Processing Issues
- Attend a different parent education workshop or intervention for Sensory Processing Issues throughout the duration of the current study
Trial locations and contacts
1 site in 1 country.
Amanda Cyr contact
Canada1 site, 1 recruiting
- Recruiting
Holland Bloorview Kids Rehabilitation Hospital
Toronto, Ontario, M4G 1R8
Yani Hamdani, 4169780528, y.hamdani@utoronto.ca
About this study
Official title: The Impact of an Education Workshop on Parental Sense of Competence
The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment. The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives.
Read the detailed description
Introduction. Parents of children with sensory processing issues (SPIs) experience decreased levels of parental sense of competence (PSOC) in managing SPI-related behaviours that challenge conventional parenting skills. Occupational therapy (OT)-led parent education workshops (PEWs) have been found to increase the PSOC of parents of children with SPIs who have a formal Autism Spectrum Disorder (ASD) diagnosis. However, research is limited on how these interventions affect PSOC of parents of children with SPIs who do not have a formal diagnosis, and are still on the waitlist for a neurodevelopmental assessment. This is vital as children with SPIs and their parents may have limited access to specialist referrals, government-funded interventions, or support services while they await a diagnostic assessment. SPI-related workshops may provide an opportunity to support families and promote PSOC and well-being by providing strategies to address SPI-related behaviours while they wait (which may be beneficial regardless of whether their child eventually receives a formal neurodevelopmental diagnosis or not). Objectives. The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment. The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives. Methods. Parents will be recruited from the waitlist for a neurodevelopmental assessment for their children through the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital. Participants will be randomly selected to attend one of two identical workshops scheduled two weeks apart. The PSOC Scale, along with demographics and follow-up questionnaires that include both closed and open-ended questions, will be administered to parents pre- and post-workshop attendance. Descriptive statistics, an independent sample t-test and a two-way Analysis of Variance (ANOVA) will be used to analyze quantitative data from these outcome measures. To analyze the qualitative data (parents' open ended responses on the follow-up feedback questionnaire), a content analysis will be completed, which will be used to complement the quantitative results, as well as provide feedback regarding the content, format, and delivery of the parent education workshop. Practice Implications. Results from this study can provide evidence to support the need for parent education workshops in improving the PSOC of parents of children on the waitlist for a neurodevelopmental assessment, promote mental health and wellbeing of parents while they wait for the assessment, promote parenting that helps children with SPIs engage in daily life occupations, and inform the development of future workshops. Conclusion. Information garnered from this study can inform the development of OT services that can address the current gap in care while parents and their children with SPIs are waiting for a formal neurodevelopmental assessment and referrals to publicly funded services funded for specific diagnosis.
- Conditions
- Parents
- Being tested
- parental sense of competence workshop
- Keywords
- parenting, parental sense of competence, children, sensory processing issues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
parental sense of competence workshopBehavioural
The intervention will be a two-hour parent education workshop that provides education and teaches parent-mediated strategies for managing children's behaviours associated with SPIs.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Parents of children with sensory processing issues who attend Workshop 1 Receives: Behavioral: parental sense of competence workshop |
| Waitlist Control | No intervention | parents of children with sensory processing issues who attend Workshop 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Parental Sense of Competence (PSOC) Scale
The Parental Sense of Competence (PSOC) scale is a self-report scale that measures and assesses parent self-efficacy on two dimensions: Satisfaction and Self-Efficacy. It is a 17-item scale, with each item rated on a 6-point Likert scale, anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". Nine (9) items (#2, 3, 4, 5, 8, 9, 12, 14, 16) on the PSOC are reverse coded. Once reverse coded, the score for each item is added up to give the "total score" for this scale. The minimum and maximum total scores (total range) are 17 and 102, respectively. No subscale scores are reported. A higher total score indicates a higher parenting sense of competency; a lower total score indicates a lower parenting sense of competency. There are no average scores or "cut offs" for this tool.
Measured: One Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2019
- Study start31 Jan 2020 (estimated)
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ParentsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- pilot randomized waitlist control design
- Masking
- None (open label)
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holland Bloorview Kids Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto
- Responsible party
- Principal investigator, Yani Hamdani, PhD, Holland Bloorview Kids Rehabilitation Hospital
- Investigators
- Yani Hamdani, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04107792
- Sponsor's protocol ID
- SPIStudy
- Status last verified
- Feb 2020
- First submitted
- 26 Sep 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of an Education Workshop on Parental Sense of Competence
- ClinicalTrials.gov ID
- NCT04107792
- Acronym / sponsor ID
- SPIStudy
- Conditions
- Parents
- Keywords
- parenting, parental sense of competence, children, sensory processing issues
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Holland Bloorview Kids Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Toronto
- Study start
- 31 Jan 2020 (estimated)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 27 Sep 2019 (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 primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment. The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives.
Detailed description
Introduction. Parents of children with sensory processing issues (SPIs) experience decreased levels of parental sense of competence (PSOC) in managing SPI-related behaviours that challenge conventional parenting skills. Occupational therapy (OT)-led parent education workshops (PEWs) have been found to increase the PSOC of parents of children with SPIs who have a formal Autism Spectrum Disorder (ASD) diagnosis. However, research is limited on how these interventions affect PSOC of parents of children with SPIs who do not have a formal diagnosis, and are still on the waitlist for a neurodevelopmental assessment. This is vital as children with SPIs and their parents may have limited access to specialist referrals, government-funded interventions, or support services while they await a diagnostic assessment. SPI-related workshops may provide an opportunity to support families and promote PSOC and well-being by providing strategies to address SPI-related behaviours while they wait (which may be beneficial regardless of whether their child eventually receives a formal neurodevelopmental diagnosis or not). Objectives. The primary objective of this pilot randomized waitlist control trial is to evaluate the impact of an OT-led parent education workshop on the PSOC of parents of children experiencing SPIs who are on the waitlist for a neurodevelopmental diagnostic assessment. The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives. Methods. Parents will be recruited from the waitlist for a neurodevelopmental assessment for their children through the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital. Participants will be randomly selected to attend one of two identical workshops scheduled two weeks apart. The PSOC Scale, along with demographics and follow-up questionnaires that include both closed and open-ended questions, will be administered to parents pre- and post-workshop attendance. Descriptive statistics, an independent sample t-test and a two-way Analysis of Variance (ANOVA) will be used to analyze quantitative data from these outcome measures. To analyze the qualitative data (parents' open ended responses on the follow-up feedback questionnaire), a content analysis will be completed, which will be used to complement the quantitative results, as well as provide feedback regarding the content, format, and delivery of the parent education workshop. Practice Implications. Results from this study can provide evidence to support the need for parent education workshops in improving the PSOC of parents of children on the waitlist for a neurodevelopmental assessment, promote mental health and wellbeing of parents while they wait for the assessment, promote parenting that helps children with SPIs engage in daily life occupations, and inform the development of future workshops. Conclusion. Information garnered from this study can inform the development of OT services that can address the current gap in care while parents and their children with SPIs are waiting for a formal neurodevelopmental assessment and referrals to publicly funded services funded for specific diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- pilot randomized waitlist control design
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: parental sense of competence workshopParents of children with sensory processing issues who attend Workshop 1 |
| Waitlist Control | No intervention | –parents of children with sensory processing issues who attend Workshop 2 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Parents of children with Sensory Processing Issues
- On the waitlist for a neurodevelopmental diagnostic assessment at the "Communication, Learning, and Behaviour" clinic at Holland Bloorview Kids Rehabilitation Hospital
- At least 18 years of age or older
- Target child(ren) with SPIs must be between the ages of 0-17 years (which is the age restriction of the Parental Sense of Comptence scale)
- The child(ren)'s scheduled neurodevelopmental diagnostic assessment date must be after their final completion of the Parental Sense of Competence Scale (two weeks following workshop attendance) to control for any external influence that a formal diagnosis may have on participants' Parental Sense of Competence
Key exclusion criteria (2 listed)
- Previously attended a parent education workshop or intervention targeting Sensory Processing Issues
- Attend a different parent education workshop or intervention for Sensory Processing Issues throughout the duration of the current study
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 |
|---|---|---|
| parental sense of competence workshopThe intervention will be a two-hour parent education workshop that provides education and teaches parent-mediated strategies for managing children's behaviours associated with SPIs. | Behavioural | Experimental |
Primary outcome
Parental Sense of Competence (PSOC) Scale
Time frame: One Month
The Parental Sense of Competence (PSOC) scale is a self-report scale that measures and assesses parent self-efficacy on two dimensions: Satisfaction and Self-Efficacy. It is a 17-item scale, with each item rated on a 6-point Likert scale, anchored by 1 = "Strongly Disagree" and 6 = "Strongly Agree". Nine (9) items (#2, 3, 4, 5, 8, 9, 12, 14, 16) on the PSOC are reverse coded. Once reverse coded, the score for each item is added up to give the "total score" for this scale. The minimum and maximum total scores (total range) are 17 and 102, respectively. No subscale scores are reported. A higher total score indicates a higher parenting sense of competency; a lower total score indicates a lower parenting sense of competency. There are no average scores or "cut offs" for this tool.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2020.
- Individual participant dataSharing planned: No
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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.
Amanda Cyr contact
Yani Hamdani, PhD principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing parental sense of competence workshop in people with Parents, run by Holland Bloorview Kids Rehabilitation Hospital at 1 site in Canada.
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 7 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 11 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yani Hamdani, PhD (4165780528, y.hamdani@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Parental Sense of Competence (PSOC) Scale (time frame: One Month). 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 11 Feb 2020.