Municipal Transition and Intervention Program for Premature infants and their parents.

ISRCTN	ISRCTN65503576
DOI	https://doi.org/10.1186/ISRCTN65503576
Secondary identifying numbers	1

Submission date: 20/12/2005
Registration date: 20/12/2005
Last edited: 23/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr M.J. Wolf
Scientific

Department of Rehabilitation, A01
Academic Medical Center
P.O. Box 22660
Amsterdam
1100 DD
Netherlands

Study information

Study design	Multicentre, randomised, single blind, active controlled, parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	STIPP
Study objectives	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(s)	Ethics approval received from the local medical ethics committee
Health condition(s) or problem(s) studied	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
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 study start date	01/01/2004
Completion date	31/12/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	Both
Target number of participants	180
Key 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
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	31/12/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Department of Rehabilitation, A01

Amsterdam
1100 DD
Netherlands

Sponsor information

Academic Medical Centre (AMC) (Netherlands)
University/education

Meibergdreef 9
Amsterdam
1105 AZ
Netherlands

Website	http://www.amc.uva.nl/
"ROR"	https://ror.org/03t4gr691

Funders

Funder type

Government

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

No information available

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	pilot study results	01/02/2005	Yes	No
Results article	results	01/03/2010	Yes	No
Results article	results	01/12/2011	Yes	No
Results article	results	01/03/2012	Yes	No
Results article	results	01/08/2012	Yes	No
Results article	results	01/11/2013	Yes	No