Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Acronym
STIPP
Study hypothesis
The hypothesis is that infants who receive the Infant Behavioural Assessment and Intervention Program (IBAIP) will be able to regulate themselves better and that disabilities will therefore be prevented or develop to a less serious degree.
Ethics approval
Ethics approval received from the local medical ethics committee
Study design
Multicentre, randomised, single blind, active controlled, parallel group trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Behavioural self-regulation and/or psychomotor problems
Intervention
For the intervention the IBA Intervention Program (IBAIP) will be used. The theoretical framework underlying the IBAIP is the "Synactive Model of Newborn Behavioural Organisation and Development".
The intervention aims at improving the developmental outcome of the child by assisting the parents as early as possible to support their childs self regulation at a stage where changes are still reversible. The intervention method does not only support the child, but the parents as well, by offering them emotional, practical and individual support, so that excessive stress can be prevented.
By means of standardised IBA observations the childs self regulating skills are examined.
All the childs behavioural expressions and the inter-relationship are observed systematically and are interpreted by means of 4 systems:
1. The autonomic system
2. The motor system
3. The state system
4. The attention-interaction system
With the help of this neurological behaviour assessment one judges how a child can play with its various systems and is able to use them to achieve its goal. Consequently the measure of self-regulation determines the amount of support/intervention that should be offered.
The parental support consists of an increased awareness of their babys behavioural expressions and the interpretation of these expressions, so that the parents learn to intermediate between their childs regulatory skills and the environment. The support they give may affect the environment (e.g. light, sounds, social interaction), functional positioning and ways of handling and the childs specific self-regulatory strategies (e.g. sucking, holding something, seeking support).
As the child grows older it is to be expected that there will be an increase in the childs self regulatory skills and consequently a decrease in the need for support/intervention. The family composition, the cultural diversity and the social/cultural safety network of the (often immigrant) parents will explicitly be taken into account during the project. After each home visit a report will be sent to the parents. This report will especially stress the competencies of the child and its parents. The interventions will be given by specially trained paediatric physical therapists that have the IBAIP certificate.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. The Bayley Scales of Infant Development-II (BSID-II) at the corrected age of 24 months
2. The Still Face procedure at 6 months
3. The Working Model of Child Interview at 18 months
Secondary outcome measures
1. The Infant Behavioural Assessment at 6 months
2. The BSID-II at 6 and 12 months
3. The Infant Toddler Symptom Checklist at 6, 12 and 24 months
4. The General Health Questionnaire at 6, 12 and 24 months
Overall trial start date
01/01/2004
Overall trial end date
31/12/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Gestation of less than 32 weeks and/or birth weight less than 1500 grams
2. Born in one of the Amsterdam hospitals
3. The infant's parents live in the Amsterdam area
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
180
Participant exclusion criteria
1. Chromosome or syndrome disease
2. Children of addicted mothers (hard drugs or alcohol)
3. Parents unable to communicate in Dutch or English and who have no interpreter
4. Mothers with severe psychiatric illness
Recruitment start date
01/01/2004
Recruitment end date
31/12/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Rehabilitation, A01
Amsterdam
1100 DD
Netherlands
Sponsor information
Organisation
Academic Medical Centre (AMC) (Netherlands)
Sponsor details
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Reserve Voormalige Vrijwillige Ziekenfondsen (RVVZ) (Netherlands) - a governmental non-profit health organisation
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2005 pilot study results in http://www.ncbi.nlm.nih.gov/pubmed/15707233
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/19880139
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21784445
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/21981307
5. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22406323
6. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23766396
Publication citations
-
Pilot study results
Koldewijn K, Wolf MJ, van Wassenaer A, Beelen A, de Groot IJ, Hedlund R, The Infant Behavioral Assessment and Intervention Program to support preterm infants after hospital discharge: a pilot study., Dev Med Child Neurol, 2005, 47, 2, 105-112.
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Results
Koldewijn K, van Wassenaer A, Wolf MJ, Meijssen D, Houtzager B, Beelen A, Kok J, Nollet F, A neurobehavioral intervention and assessment program in very low birth weight infants: outcome at 24 months., J. Pediatr., 2010, 156, 3, 359-365, doi: 10.1016/j.jpeds.2009.09.009.
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Results
Verkerk G, Jeukens-Visser M, Koldewijn K, van Wassenaer A, Houtzager B, Kok J, Nollet F, Infant behavioral assessment and intervention program in very low birth weight infants improves independency in mobility at preschool age., J. Pediatr., 2011, 159, 6, 933-8.e1, doi: 10.1016/j.jpeds.2011.05.035.
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Results
Koldewijn K, van Hus J, van Wassenaer A, Jeukens-Visser M, Kok J, Nollet F, Wolf MJ, Reliability, sensitivity and responsiveness of the Infant Behavioral Assessment in very preterm infants., Acta Paediatr., 2012, 101, 3, 258-263, doi: 10.1111/j.1651-2227.2011.02481.x.
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Results
Verkerk G, Jeukens-Visser M, Houtzager B, Koldewijn K, van Wassenaer A, Nollet F, Kok J, The infant behavioral assessment and intervention program in very low birth weight infants; outcome on executive functioning, behaviour and cognition at preschool age., Early Hum. Dev., 2012, 88, 8, 699-705, doi: 10.1016/j.earlhumdev.2012.02.004.
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Results
Van Hus JW, Jeukens-Visser M, Koldewijn K, Van Sonderen L, Kok JH, Nollet F, Van Wassenaer-Leemhuis AG, Comparing two motor assessment tools to evaluate neurobehavioral intervention effects in infants with very low birth weight at 1 year., Phys Ther, 2013, 93, 11, 1475-1483, doi: 10.2522/ptj.20120460.