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'Leef je in!'


- candidate number22842
- NTR NumberNTR5415
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR8-sep-2015
- Secondary IDsNL52833.072.15 
- Public Title'Leef je in!'
- Scientific Title'Leef je in!': a social cognitive skills training for children with mild to borderline intellectual disabilities.
- ACRONYM
- hypothesisIt is hypothesized that a training in the two social cognitive skills, emotion recognition and perspective taking, will improve the prosocial behavior of the children with mild to borderline intellectual disablilities (MBID), because they have a better understanding of what is happening in social situations. In addition, we expect that the children with mild to borderline intellectual disabilities can benefit more from the treatment in the residential treatment centre, because they have developed the basic social cognitive skills which are required to participate in many other interventions. Because of that, we expect that on the long term the children will show less behavior problems.
- Healt Condition(s) or Problem(s) studiedCognitive problems, Behavioral problems, Social functioning
- Inclusion criteria- Children with mild to borderline intellectual disabilities who live in a residential treatment centre
- Children aged between 10 and 16 years old
- Children have to be at the start of their treatment in the institute, with a maximum of one year in treatment.
- Exclusion criteriaChildren have to be able to follow an intervention in a group.
- mec approval receivedno
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-nov-2015
- planned closingdate1-jul-2017
- Target number of participants120
- InterventionsThe intervention ‘Leef je in!’ is developed together with the target group, group workers and scientists. The protocol-driven group intervention for children is guided by two trainers (group workers). The intervention consists of 16 one hour meetings and takes 11 weeks. The intervention uses several methods, such as elements of the cognitive behavioral therapy. Furthermore, the intervention uses many active assignments, like role-play and playing games. Finally, an important method of the intervention is generalization. Generalization means that what has been learnt by the children during the intervention can also be shown in situations outside the intervention. This generalization is been done in several ways; at first the intervention is given by group workers of the treatment group where participants live, so they can remind the children of what they have learnt, also outside the training. The intervention takes place in the living room of the treatment group. Furthermore, the participants make homework assignments. The themes used in the intervention are selected with the target group and group workers. Lastly, the whole team of group workers (not just the trainers) will be trained in giving the intervention.
- Primary outcomeEmotion recognition (Radboud Faces, Matching Faces)
Perspective taking (Social Cognitive Skills Test, Turntables, Mysterious drawings)
- Secondary outcomeProsocial behavior, filled in by their group wroker and teacher (Strengths and Difficulties Questionnaire (SDQ))
Behavior problems, filled in by their group worker and teacher (Strengths and Difficulties Questionnaire (SDQ))
- TimepointsBaseline
3 months
6 months
9 months
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES Judith Arendsen
- CONTACT for SCIENTIFIC QUERIES Floor Santvoort
- Sponsor/Initiator Pluryn Research & Development
- Funding
(Source(s) of Monetary or Material Support)
Couvee Foundation
- Publications
- Brief summaryThe objective of this study is to evaluate the effectiveness of the social cognitive skills intervention Leef je in!. The effectiveness of the intervention will be tested in a randomized controlled trial with two parallel conditions: an intervention condition and a control condition. Measurements take place at baseline (0 months), posttest (3 months) and follow-up after 6 months and 9 months.

The aim of the intervention is to improve two social cognitive skills of children with MBID: 1) emotion recognition and 2) perspective taking. Children with mild to borderline intellectual disabilities show deficits in these social cognitive skills, that is a reason why they experience more behavior problems. We expect that the intervention will be beneficial to the prosocial behavior of the children with mild to borderline intellectual disabilities, because they have a better understanding of what is happening in social situations. In addition, we expect that the children with mild to borderline intellectual disabilities can benefit more from the treatment in the residential treatment centre, because they have developed the basic social cognitive skills, which are required to participate in many other interventions. Because of that, we expect that on the long term the children will show less behavior problems.

The intervention ‘Leef je in!’ is suitable for (almost) all children with mild to borderline intellectual disabilities who are living in a residential treatment centre, because most children with MBID who live in residential treatment centres show deficits in their social cognitive skills. The intervention ‘Leef je in!’ is developed together with the target group, group workers and scientists. The group intervention for 4 children is protocol-driven and is given by two trainers (group workers).
- Main changes (audit trail)
- RECORD8-sep-2015 - 28-okt-2015


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