Prevention Among Young People With Intellectual Disability

Not Applicable

• Conditions: Intellectual Disability; Adolescent Development; Young Adult
• Interventions: Behavioral: "Children - what does it involve?"

• Registration Number: NCT03348124
• Lead Sponsor: Uppsala University

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.

Study Timeline

• Study First Submitted: 2017-11-10
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Study Start: 2018-01-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-03
• Last Update Posted: 2018-05-04
• Primary Completion: 2020-12-31
• Study Completion: 2021-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	"Children - what does it involve?"	Educational lessons based on the conversational material Toolkit "Children - what does it involve?", will be delivered in the classroom at school and caring for the RCB simulator during three days and nights.

Primary Outcome Measures

Name	Time	Method
Infant Simulator Attitude Scale (ISA)	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 Outcome Measures

Name	Time	Method
General Self-Efficacy Scale (S-GSE)	Change from baseline after 13 weeks	The S-GSE contains 10 items and it has already been used in Sweden. The investigators adapted two of the items and added the response alternative "I do not know". The layout of the response alternatives was adapted to individuals with cognitive disability and the students were given the opportunity to use pictures or sign language for ease of understanding.
Data extracted from Real Care Baby simulator	Change from baseline after three days and nights	Proper care, mishandle and performance - mean and range in percent

Trial Locations

Locations (1)

Uppsala Special school; 🇸🇪 Uppsala, Sweden