Ignite Creation Date:
2024-05-06 @ 6:59 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05857865
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-05-15
First Post:
2023-03-31
Brief Title:
Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
Sponsor:
University of Manitoba
Organization:
University of Manitoba
Study Overview
Official Title:
Single-Session Psychotherapy for Young Kids Through Patient Engagement Techniques
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SPYKids
Brief Summary:
The goal of this clinical trial is to compare outcomes between participants in the single-session psychotherapy for young kids SPYKids conditions and participants in the services as usual SAU condition The main questions it aims to answer are
What is the feasibility and acceptability of SPYKids compared to services as usual
What are the changes in child mental health between the SPYKids group compared with the SAU group
Participants will
Fill out questionnaires at baseline immediately post-program approximately one month after the baseline assessment and three months after the baseline assessment
Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns
Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being parent well-being and parent self-efficacy
What is the feasibility and acceptability of SPYKids compared to services as usual
What are the changes in child mental health between the SPYKids group compared with the SAU group
Participants will
Fill out questionnaires at baseline immediately post-program approximately one month after the baseline assessment and three months after the baseline assessment
Meet with a parent coach in a virtual 90-minute session to discuss coping strategies relevant to their identified concerns
Researchers will compare participants in the SPYKids group with participants in the Services as Usual group to see if there are changes in child well-being parent well-being and parent self-efficacy
Detailed Description:
The coronavirus disease of 2019 COVID-19 pandemic has contributed to elevated stress experienced by parents and caregivers of children with neurodevelopmental disorders NDDs resulting in increased demand for relevant specialized services Current waitlists for NDD assessments following referral are approximately 12 months in Manitoba with similar lengths of 6-30 months across Canada which can result in children aging out of some early intervention services The SPYKids program aims to provide families with help encouragement and motivation to cope with family stressors while on waitlists at local organizations through a single-session consultation model A single-session intervention SSI is designed to increase parental ability to understand and address emergent mental health problems by teaching parents how to support childrens emotional development and impulse control to reduce mental health problems while reducing high-conflict parenting that can worsen mental health over time The present study aims to test the feasibility and value of SSIs in a 2-arm randomized control trial which will include one 90-minute consultation with psychoeducation identification of a primary mental health issue an opportunity to practice the skills and an action plan for the family to apply the skills independently The long-term goal is to create an evidence-based accessible and rapidly deployable intervention to promote well-being for children with NDDs and their families
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None