search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


Validation of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and evaluation of the BITSEA as a screening tool in Youth Health Care for preschool children.


- candidate number6535
- NTR NumberNTR2035
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-sep-2009
- Secondary IDs80-82435-98-8058 ZonMw project number
- Public TitleValidation of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and evaluation of the BITSEA as a screening tool in Youth Health Care for preschool children.
- Scientific TitleValidation of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) and evaluation of the BITSEA as a screening tool in Youth Health Care for preschool children.
- ACRONYM
- hypothesisThe use of the BITSEA as screening tool compared to Kort Instrument voor Psychologische en Pedagogische Probleem Inventarisatie (KIPPPI-2 – a screening instrument for psychological and developmental problems designed for 2 year olds), results in more appropriate and timely care; and it also results in fewer emotional and behavioral problems at 1 year follow-up in the BITSEA group (intervention condition) compared to the KIPPPI-2 group (control condition).
- Healt Condition(s) or Problem(s) studiedEmotional problems in children, Behavioural disorders
- Inclusion criteriaChildren in the age of 24 months visiting the Youth Health Care centre for well-child visits with their parents.
- Exclusion criteriaChildren currently under medical or psychological treatment are excluded.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-mrt-2010
- planned closingdate1-sep-2013
- Target number of participants3000
- InterventionsTwo types of screening instruments/procedures will be compared: the BITSEA administered in one group and the KIPPPI-2 administered in another group. During approximately a one-and-a halve-year period (until we have at least 3000 participants) these two questionnaires will be used in youth health care centers as a basis for potential referral to other health practitioners.
- Primary outcomeEmotional and behavioral problems.
- Secondary outcome1. Quality of life;
2. Referrals and consumed care;
3. Satisfaction of parents and health care professionals with the questionnaires (both BITSEA and KIPPPI-2).
- Timepoints1. Baseline questionnaire (child age 24 months);
2. Follow-up questionnaire (child age 36 months).
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESMSc I. Kruizinga
- CONTACT for SCIENTIFIC QUERIESMD, PhD H. Raat
- Sponsor/Initiator Erasmus Medical Center, Department of Public Health
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryThe prevalence of emotional and behavioural problems among preschool children is high. Early detection and treatment of emotional and behavioural problems have a positive effect on prognosis. However, currently many cases are being missed. In the Netherlands, an advisory commission to the government strongly suggested to implement and to evaluate the test properties and impact of the Brief Infant-Toddler Social and Emotional Assessment (BITSEA) for the purpose of screening of emotional and behavioural problems among very young children (1-3 years old). We propose to validate and to evaluate the impact of the BITSEA as screening tool by youth health care (YHC) at the routine visit of parent/children at age 24 months, compared to the questionnaire currently in use; the KIPPPI-2. The KIPPPI-2 has some disadvantages; it is only used in the Netherlands (it is originally a Dutch questionnaire) and therefore unsuitable for comparison of data from other countries. Moreover, the KIPPPI-2 is a quite lengthy questionnaire and its test properties have not been studied sufficiently. The present study will be done by approximately 30 YHC-teams in the larger Rotterdam area, including non-Dutch communities as well as areas representative of the Dutch population at large. At random the YHC teams will be assigned to apply the BITSEA as a new screening tool at age 24 months (intervention condition). The other 15 YHC-teams will apply usual care (i.e. KIPPPI-2 – control condition). The Child Behavior Checklist 1,5-5 (CBCL 1,5-5 – blinded for YHC-professionals) will be used to determine concurrent validity. Bilingual versions (Dutch/Turkish, Dutch/Arabic) will be offered. Additionally, a ‘clinical’ sample of (net) 100 circa 2-year olds (18-30 months) referred to Youth Mental Health Services will be selected. Parents of these children will also complete the BITSEA and KIPPPI-2, next to the CBCL 1,5-5. Data from this sample will be used to determine cut-off points for the scores of the screening tools. Moreover, in a separate sample, test-retest reliability and inter-rater reliability will be determined.
- Main changes (audit trail)
- RECORD29-sep-2009 - 4-nov-2009


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl