Prevention Among Young People With Intellectual Disability

NCT03348124 | Unknown

• 1 other identifier: Prevention ID
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Intellectual Disability; Adolescent Development; Young Adult

Keywords

Intellectual disability; Parenthood; Reproduction; Intervention; Adolescents

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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 Arms (2)

Intervention

EXPERIMENTAL

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.

Behavioral: "Children - what does it involve?"

Control

NO INTERVENTION

Education as usual.

Interventions

"Children - what does it involve?" BEHAVIORAL

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.

Also known as: education as usual

Intervention

Eligibility Criteria

• Age: 16 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \- Students with severe ID

Sponsors & Collaborators

• Uppsala University: lead
• Uppsala-Örebro Regional Research Council: collaborator

Study Sites (1)

Uppsala Special school

Uppsala, 74010, Sweden

Location

MeSH Terms

Conditions

Intellectual Disability

Interventions

Educational Status

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Berit Höglund, PhD

  Uppsala University Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researchers are outcome assessors, independent from the intervention.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster randomized intervention study with waiting list control group.

Study Record Dates

• First Submitted: November 10, 2017
• First Posted: November 20, 2017
• Study Start: January 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: July 31, 2021
• Last Updated: May 4, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)