NCT04107792

Brief 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. The secondary objective is to obtain a subjective evaluation of the content, format, and delivery of the parent education workshop from the parents' perspectives.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 26, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 27, 2019

Completed
4 months until next milestone

Study Start

First participant enrolled

January 31, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

September 26, 2019

Last Update Submit

February 8, 2020

Conditions

Keywords

parentingparental sense of competencechildrensensory processing issues

Outcome Measures

Primary Outcomes (1)

  • 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.

    One Month

Study Arms (2)

Experimental

EXPERIMENTAL

Parents of children with sensory processing issues who attend Workshop 1

Behavioral: parental sense of competence workshop

Waitlist Control

NO INTERVENTION

parents of children with sensory processing issues who attend Workshop 2

Interventions

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.

Experimental

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holland Bloorview Kids Rehabilitation Hospital

Toronto, Ontario, M4G 1R8, Canada

RECRUITING

Study Officials

  • Yani Hamdani, PhD

    University of Toronto

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yani Hamdani, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: pilot randomized waitlist control design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Adjunct Scientist

Study Record Dates

First Submitted

September 26, 2019

First Posted

September 27, 2019

Study Start

January 31, 2020

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

February 11, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Locations