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Prevention Among Young People With Intellectual Disability

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03348124
Enrollment
59
Registered
2017-11-20
Start date
2018-01-01
Completion date
2021-07-31
Last updated
2018-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adolescent Development, Intellectual Disability, Young Adult

Keywords

Intellectual disability, Parenthood, Reproduction, Intervention, Adolescents

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.

Interventions

BEHAVIORALChildren - 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.

Sponsors

Uppsala-Örebro Regional Research Council
CollaboratorOTHER
Uppsala University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Masking description

The researchers are outcome assessors, independent from the intervention.

Intervention model description

Cluster randomized intervention study with waiting list control group.

Eligibility

Sex/Gender
ALL
Age
16 Years to 21 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Infant Simulator Attitude Scale (ISA)Change from baseline after 13 weeksThe 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

MeasureTime frameDescription
General Self-Efficacy Scale (S-GSE)Change from baseline after 13 weeksThe 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 simulatorChange from baseline after three days and nightsProper care, mishandle and performance - mean and range in percent

Countries

Sweden

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026