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Clinical Trials/ISRCTN11192967
ISRCTN11192967
Active, not recruiting
未知

A cluster randomised controlled trial of Early Positive Approaches to Support (E-PAtS) for families of young children with intellectual disability (E-PAtS RCT)

niversity of Kent0 sites594 target enrollmentAugust 10, 2023

Overview

Phase
未知
Intervention
Not specified
Conditions
Intellectual disability
Sponsor
niversity of Kent
Enrollment
594
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 10, 2023
End Date
June 30, 2026
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
niversity of Kent

Eligibility Criteria

Inclusion Criteria

  • First parent/caregiver:
  • 1\. With at least one child with an ID aged 18 months to 6 years
  • 2\. The identified child with ID meets the following:
  • 3\.1\. Has a diagnosis or in process of exploring a diagnosis or presentation related to intellectual and/or developmental disability – including but not restricted to Learning Disability, Global Developmental Delay, Autism, Pervasive Developmental Delay or Special Educational Needs
  • 3\.2\. Has a standard composite score on the Domain\-level version of the Vineland Adaptive Behaviour Scales III Domain Version of \<80
  • 4\. Available to attend the E\-PAtS intervention
  • 5\. \=18 years old
  • 6\. Has sufficient level of English language enabling (verbal) completion of outcome measures
  • 7\. Able to provide informed consent
  • Second parent/caregiver:

Exclusion Criteria

  • First parent/caregiver:
  • 1\. The identified child with ID is in a 24hr residential placement
  • 2\. The identified child with ID is in a foster placement due to end before the 12\-month post\-randomisation follow\-up data collection point
  • 3\. Parent/caregiver enrolled at baseline in a group or individually\-delivered parenting programme outside of the study
  • 4\. Parent/caregiver enrolled in a programme of personal psychological therapeutic support at baseline
  • 5\. Parent/caregiver in the family has already participated in an E\-PAtS group
  • 6\. There are current child protection concerns relating to the identified child with ID that have been identified by professionals/services and indicated to programme facilitators or their host organisation at the point of recruitment
  • 7\. The family are recognised to be in a state of current crisis and unable to cope/a score of 8\-10 on the 10\-point Brief Family Distress Scale
  • Second parent/caregiver:
  • 1\. Enrolled at baseline in a group or individually delivered parenting programme outside of the study

Outcomes

Primary Outcomes

Not specified

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