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
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
1100 DD
Netherlands
Sponsor information
Academic Medical Centre (AMC) (Netherlands)
University/education
University/education
Meibergdreef 9
Amsterdam
1105 AZ
Netherlands
Website | http://www.amc.uva.nl/ |
---|---|
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 | Date added | 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 |