Prevention Among Young People With Intellectual Disability

• ClinicalTrials.gov Identifier: NCT03348124
• Recruitment Status: Unknown
• First Posted: November 20, 2017
• Last Update Posted: May 4, 2018
• Sponsor: Uppsala University
• Collaborator: Uppsala-Örebro Regional Research Council
• Information provided by (Responsible Party): Uppsala University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Intellectual Disability; Adolescent Development; Young Adult	Behavioral: "Children - what does it involve?"	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: Cluster randomized intervention study with waiting list control group.
• Masking: Single (Outcomes Assessor)
• Masking Description: The researchers are outcome assessors, independent from the intervention.
• Primary Purpose: Prevention
• 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
• Actual Study Start Date: January 1, 2018
• Estimated Primary Completion Date: December 31, 2020
• Estimated Study Completion Date: July 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention; 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?"; 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.; Other Name: education as usual
No Intervention: Control; Education as usual.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. General Self-Efficacy Scale (S-GSE) [ Time Frame: 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.
2. Data extracted from Real Care Baby simulator [ Time Frame: Change from baseline after three days and nights ]
   Proper care, mishandle and performance - mean and range in percent

Eligibility Criteria

• Ages Eligible for Study: 16 Years to 21 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

Sweden

Uppsala Special school

Uppsala, Sweden, 74010

Sponsors and Collaborators

Uppsala University

Uppsala-Örebro Regional Research Council

Investigators

• Principal Investigator: Berit Höglund, PhD; Uppsala University Sweden

More Information

• Responsible Party: Uppsala University
• ClinicalTrials.gov Identifier: NCT03348124
• Other Study ID Numbers: Prevention ID
• First Posted: November 20, 2017
• Last Update Posted: May 4, 2018
• Last Verified: May 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Uppsala University:

Intellectual disability; Parenthood; Reproduction; Intervention; Adolescents

Additional relevant MeSH terms:

Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Neurodevelopmental Disorders; Mental Disorders