Prevention Among Young People With Intellectual Disability

Intellectual Disability Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03348124
• Other study ID #: Prevention ID
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: July 31, 2021

Study information

• Verified date: May 2018
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 59
• Est. completion date: July 31, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Adolescent Development
• Intellectual Disability
• Young Adult

Intervention

Behavioral:
• "Children - what does it involve?"
Thirteen educational lessons based on the conversational material Toolkit will be delivered in the classroom at school, two lessons per theme. The themes consists of: 1) a card game: "What i wish" 2) Time 3) Money 4) Skills 5) Relations 6) Housing. The material is prepared and same for all schools. This intervention will be given 1-2 lessons per week over a period of 8-14 weeks. During this period the students also care for the RCB simulator during three days and nights, but with a break for "day care" for the simulator which was between 7 am and 5 pm when the students were in school. All students will practice handling the simulator to be familiar with all types of needs: to rock, change diaper, feed and burp and were taught the skills of head support, techniques to avoid rough handling.

Locations

Country	Name	City	State
Sweden	Uppsala Special school	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Centre for Clinical research in Dalarna, Uppsala university, Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Infant Simulator Attitude Scale (ISA)	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.	Change from baseline after 13 weeks
Secondary	General Self-Efficacy Scale (S-GSE)	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.	Change from baseline after 13 weeks
Secondary	Data extracted from Real Care Baby simulator	Proper care, mishandle and performance - mean and range in percent	Change from baseline after three days and nights