Condition category
Mental and Behavioural Disorders
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr M.J. Wolf


Contact details

Department of Rehabilitation
Academic Medical Center
P.O. Box 22660
1100 DD

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type


Patient information sheet


Behavioural self-regulation and/or psychomotor problems


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 child’s 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 child’s self regulating skills are examined.
All the child’s 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 baby’s behavioural expressions and the interpretation of these expressions, so that the parents learn to intermediate between their child’s 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 child’s 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 child’s 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



Not Specified

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Department of Rehabilitation, A01
1100 DD

Sponsor information


Academic Medical Centre (AMC) (Netherlands)

Sponsor details

Meibergdreef 9
1105 AZ

Sponsor type




Funder type


Funder name

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

Reserve Voormalige Vrijwillige Ziekenfondsen (RVVZ) (Netherlands) - a governmental non-profit health organisation

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

1. 2005 pilot study results in
2. 2010 results in
3. 2011 results in
4. 2012 results in
5. 2012 results in
6. 2013 results in

Publication citations

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Additional files

Editorial Notes