Intellectual DisabilityNCT03348124
Prevention Among Young People With Intellectual Disability
A study testing "Children - what does it involve?" in people with Intellectual Disability and Adolescent Development, run by Uppsala University at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 16 to 21 years
- Conditions the study is for
- Intellectual Disability, Adolescent Development, Young Adult
- What is being tested?
- "Children - what does it involve?"
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- 1 Jan 2018to 31 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Students with mild or moderate ID with informed consent can be included
- Understand and respond to a questionnaire
Who cannot join
- Students with severe ID
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Intellectual Disability, Adolescent Development, Young Adult
- Being tested
- "Children - what does it involve?"
- Keywords
- Intellectual disability, Parenthood, Reproduction, Intervention, Adolescents
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"Children - what does it involve?"Behavioural
Also called education as usual
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: "Children - what does it involve?" |
| Control | No intervention | Education as usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline after 13 weeks
Secondary outcomes (2)
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.
Measured: Change from baseline after 13 weeks
Data extracted from Real Care Baby simulator
Proper care, mishandle and performance - mean and range in percent
Measured: Change from baseline after three days and nights
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2017
- Study start1 Jan 2018
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intellectual DisabilityStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster randomized intervention study with waiting list control group.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 59 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Responsible party
- Sponsor
- Investigators
- Berit Höglund, PhD, Principal investigator, Uppsala University Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03348124
- Sponsor's protocol ID
- Prevention ID
- Status last verified
- May 2018
- First submitted
- 10 Nov 2017
- Last updated
- 4 May 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03348124
- Acronym / sponsor ID
- Prevention ID
- Conditions
- Intellectual Disability, Adolescent Development, Young Adult
- Keywords
- Intellectual disability, Parenthood, Reproduction, Intervention, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 59 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala-Örebro Regional Research Council
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Jul 2021 (estimated)
- First posted
- 20 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Cluster randomized intervention study with waiting list control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: "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. |
| Control | No intervention | –Education as usual. |
Who may qualify
- Ages
- 16 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Students with mild or moderate ID with informed consent can be included
- Understand and respond to a questionnaire
Key exclusion criteria (1 listed)
- Students with severe ID
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "Children - what does it involve?"Also: education as usualThirteen 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. | Behavioural | Intervention |
Primary outcome
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.
2 secondary outcomes
General Self-Efficacy Scale (S-GSE)
Time frame: Change from baseline after 13 weeks
Data extracted from Real Care Baby simulator
Time frame: Change from baseline after three days and nights
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Berit Höglund, PhD principal investigator
Uppsala University Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "Children - what does it involve?" in people with Intellectual Disability and Adolescent Development, run by Uppsala University at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Simulator Attitude Scale (ISA) (time frame: Change from baseline after 13 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2018.