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Social and psychological support for adolescents and young adults with Neurofibromatosis type 1


- candidate number15610
- NTR NumberNTR4226
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-okt-2013
- Secondary IDsNL41659.078.12 
- Public TitleSocial and psychological support for adolescents and young adults with Neurofibromatosis type 1
- Scientific TitleSocial and psychological support for adolescents and young adults with NF1
- ACRONYMSPOT-NF1
- hypothesisThe disease related intervention improves the psychosocial quality of life and self-efficacy of young adults with NF1.
- Healt Condition(s) or Problem(s) studiedNeurofibromatosis I, Social support, Participation
- Inclusion criteriaPatient diagnosed with NF1 by a doctor via the official NIH criteria;
Age: 16-30 years;
A signed informed consent by the patient and if the patient is a minor, then a signed informed consent by the parents is needed as well.
- Exclusion criteriaYoung adolescents without official diagnosis of Neurofibromatosis type 1;
Participants who do'nt have enough knowledge about the Dutch language to fill in the questionnaires.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mei-2013
- planned closingdate1-sep-2041
- Target number of participants100
- Interventions5 psychological and social support groups and a maximum of 4 individual sessions
- Primary outcomeMental quality of life (SF-36, mental scale)
- Secondary outcomePhysical quality of life (SF-36, physical scale); Self efficacy in coping with a chronic condition(Dutch versions of the On Your Own Feet - Self Efficacy Scale and General Self Efficacy Scale); Level of fatigue (Dutch version of the Checklist Individual Strength); Participation in daily life (Dutch questionnaire: Impact op Participatie en Autonomie, several subscales will be used (roughly translated): pastime and recreation, social contacts and relationships, paid work or volunteer work, education and courses; Specific questionnaire to measure the burden of appearance in NF1 (pilot dutch questionnaire "The burden of Visibility of NF1); Service satisfaction: some questions abbreviated from the Verona Service Satisfaction Scale
- TimepointsThe questionnaires will be filled in at the intake (T0) and six months later, at T=6.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES C. Bouman
- CONTACT for SCIENTIFIC QUERIES C. Bouman
- Sponsor/Initiator Erasmus Medical Center, Sophia Children's Hospital
- Funding
(Source(s) of Monetary or Material Support)
Fonds Nuts-Ohra
- PublicationsN/A
- Brief summaryFrom 2013 to 2014 we conduct a study in the Sophia Children's Hospital in Rotterdam for young people with NF1 (age 16-30 years). The aim of the study is twofold: chart the need for care and advice, quality of life, self efficacy, psychopathology and participation in society and measure the effectivity of a short, disease related intervention designed to improve psychosocial quality of life. SPOT-NF1 is a randomized controlled study: participants are randomly assigned to the treatment group or the control group, controlling for current psychological therapy. Treatment consists of five two-hour group sessions, and if needed individual sessions with social worker or psychologist and digital support by a Facebook site.
- Main changes (audit trail)
- RECORD25-okt-2013 - 23-dec-2013


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