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Tackling Teenage (Ik Puber).


- candidate number9355
- NTR NumberNTR2860
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-apr-2011
- Secondary IDs12427.0004 ZonMw
- Public TitleTackling Teenage (Ik Puber).
- Scientific TitleTackling Teenage: A study on the effectiveness of a training program on psychosexual development and intimacy in adolescents with Autism Spectrum Disorder (ASD).
- ACRONYMIP
- hypothesisThe objectives are firstly that the Tackling Teenage training increases knowledge, skills and confidence of young people with autism spectrum problems (ASP) , and that inappropriate sexual behavior decreases and secondly that the (sexual) vulnerability of these young people becomes smaller and their resistance increases.
- Healt Condition(s) or Problem(s) studiedPervasive developmental disorder, Autism, Autism Spectrum Disorders (ASDs), Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
- Inclusion criteria1. Autism Spectrum Disorder;
2. an IQ of 80 and above.
- Exclusion criteriaAn IQ lower than 80.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2011
- planned closingdate30-nov-2013
- Target number of participants200
- InterventionsThe intervention tested in this research, the Tackling Teenage training, aims to educate, support and guide young people aged 12-18 years with ASP in their psychosexual development and puberty. The training consists of eighteen lessons with subsequent assignments in which the different topics belonging to the pubertal development and psychosexual treatment are being handled. These sessions will be received over an average period of six months.
The control group will be placed on a waitinglist.
- Primary outcome1. Knowledge of puberty, sexuality and related issues, measured by a knowledge test;
2. Psychosexual development, psychosexual problems and concerns of parents and youth, measured by the Teen Transition Screen (TTS) for parents / caretakers and the adolescents;
3. Detection of sexually transgressive behavior, measured by ‘het Vlaggensysteem’;
4. Confidence / self-esteem, measured with the ‘Nederlandse Persoonlijkheidsvragenlijst’ (NPV-2);
5. Social skills in situations where intimacy and sexuality play a role as measured by vignettes and the TTS;
6. The degree of autism spectrum problems, measured by the Social Responsiveness Scale (SRS), the Autism Diagnostic Observation Schedule (ADOS) and Autism Diagnostic Interview (ADI-R);
7. Intelligence level, from file or measured by the Wechsler Abbreviated Scale of Intelligence (WASI);
8. Emotional and behavioral problems, measured by the Child Behavior Checklist (CBCL).
- Secondary outcomeN/A
- TimepointsUntil Augustus 2011: Preparation of the research, PR activities;
September 2011 – May 2013: Inclusion, randomisation, Measurement 1, Tackling Teenage training, T2, collecting data;
September 2012 – November 2013: T3, data collection;
December 2013 - April 2015: Data-analyses; spreading results.
- Trial web sitewww.ikpuber.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Kirsten Visser
- CONTACT for SCIENTIFIC QUERIES Kirsten Visser
- Sponsor/Initiator Yulius Academie
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThis research tests the effects of a training to promote the psycho-sexual and pubertal development of twelve to eighteen year olds adolescence with problems on the autism spectrum. The objectives are firstly that the Tackling Teenage training increases knowledge, skills and confidence of young people with autism spectrum problems (ASP) , and that inappropriate sexual behavior decreases and secondly that the (sexual) vulnerability of these young people becomes smaller and their resistance increases. The study design is an RCT with an experimental condition (training condition) and a control condition (waitinglist condition). The adolescents are randomly assigned to one of these conditions. Youngsters in the training condition receive the Tackling Teenage training over an average period of six months. Effects of training are investigated by comparing developments in the functioning of the youths in the two conditions, through questionnaires for the child and the parent/ caretaker of the child.
- Main changes (audit trail)10-jun-2014: Changes in studyprotocol:
The following items have been changed in the Tackling Teenage (Ik Puber) Trial information.
- INCLUSION CRITERIA
1. Autism Spectrum Disorder;
2. an Total IQ of 85 and above.

- PLANNED CLOSINGDATE
31-04-2015

- PRIMARY OUTCOME
1. Knowledge of puberty, sexuality and related issues, measured by a knowledge test;
2. Psychosexual development, psychosexual problems and concerns of parents and youth, measured by the Teen Transition Inventory (TTI) for parents / caretakers and the adolescents;
3. Detection of sexually transgressive behavior, measured by ‘het Vlaggensysteem’;
4. Confidence / self-esteem, measured with the ‘Nederlandse Persoonlijkheidsvragenlijst’ (NPV-2);
5. Social skills in situations where intimacy and sexuality play a role as measured by the Social Responsiveness Scale (SRS) and TTI;

Number 6-8 are not outcome measures, but inclusion measures (WASI & SRS), instruments to measure the ASD severity (ADOS & 3Di) and other measures of interest (CBCL).
6. The degree of autism spectrum problems, measured by the Social Responsiveness Scale (SRS), the Autism Diagnostic Observation Schedule (ADOS) and Developmental, Dimensional and Diagnostic Interview (3Di);
7. Intelligence level, from file or measured by the Wechsler Abbreviated Scale of Intelligence (WASI); 8. Emotional and behavioral problems, measured by the Child Behavior Checklist (CBCL).

- TIMEPOINTS
Until December 2011: Preparation of the research, PR activities;
January 2012 – April 2014: Inclusion, randomisation, Measurement 1, Tackling Teenage training, T2, collecting data;
October 2014 – April 2015: T3, data collection;
April 2014 – October 2015: Data-analyses; spreading results.
- AB
- RECORD20-apr-2011 - 10-jun-2014


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