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Clinical Trials/NCT03348124
NCT03348124
Unknown
Not Applicable

Prevention of Unwanted Pregnancy and a Path to Informed Choice Among Young People With Intellectual Disability- a RCT, Intervention With Conversational Support and Real-Care-Baby Simulator

Uppsala University1 site in 1 country59 target enrollmentJanuary 1, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intellectual Disability
Sponsor
Uppsala University
Enrollment
59
Locations
1
Primary Endpoint
Infant Simulator Attitude Scale (ISA)
Last Updated
8 years ago

Overview

Brief Summary

This study aims to evaluate an intervention using the Toolkit "Children - what does it involve?" and the "Real-Care-Baby" (RCB) simulator among students with intellectual disability (ID), using a cluster randomized trial design with waiting-list control group.

Detailed Description

Background: There is limited knowledge about how young people with ID can be facilitated in their process of deciding about parenthood. A feasibility study showed that it is possible to evaluate an intervention using the chosen instruments among students with ID in order to provide them with further insights about parenthood. Methods: Randomization of eleven clusters/schools to intervention and eleven clusters to waiting-list control. Intervention includes thirteen educational lessons and a three-day and night caring-session with the RCB simulator. Intervention will be given 1-2 lessons/week during 8-14 weeks. Data will be collected with questionnaires and interviews before and after intervention. In control group: Before and after waiting-list time and after intervention.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
July 31, 2021
Last Updated
8 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Uppsala University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Students with mild or moderate ID with informed consent can be included
  • Understand and respond to a questionnaire

Exclusion Criteria

  • Students with severe ID

Outcomes

Primary Outcomes

Infant Simulator Attitude Scale (ISA)

Time Frame: Change from baseline after 13 weeks

The original ISA consists of 38 items of which most are statements with four response alternatives ranging from strongly agree to strongly disagree. It was translated to Swedish and to the cognitive level of students with intellectual disability. Statements were changed into questions and one response alternative "I do not know" was added. The items related to sexual activity and to contraception were omitted since it was not the focus of the intervention and also to ease the all over burden of lengthy questionnaires for the students.

Secondary Outcomes

  • General Self-Efficacy Scale (S-GSE)(Change from baseline after 13 weeks)
  • Data extracted from Real Care Baby simulator(Change from baseline after three days and nights)

Study Sites (1)

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