To evaluate the long-term effects of early intervention in high-risk infants on the basis of the VIP-project.
ID
Source
Brief title
Condition
- Congenital and peripartum neurological conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Functioning in daily life (communication, daily living skills, socialization
and motor skills) as measured by the Vineland Adaptive Behavior Scale (VABS).
Secondary outcome
Secundary measurements:
- Developmental Coordination Disorder Questionnaire (DCD-Q)
- Child Behavior Check List (CBCL)
- General Health Questionnaire; GHQ)
- Utrechtse Coping Lijst (UCL)
- Family Empowerment Scale (FES)
- Vragenlijst VIP fysiotherapie
Background summary
Between March 2003 and May 2006 high-risk infants were randomly assigned to
study the effects of early paediatric physical therapeutical intervention on
developmental outcome of infants with or at high risk for developmental
disorders. The effects of a recently developed early intervention program COPCA
(Coping with and Caring for infants with special needs * a family centered
program) were compared to the effects of traditional infant physical therapy
(TIP). The randomized intervention was applied between 3 and 6 months corrected
age (CA). Outcome was monitored during the intervention, immediately after the
intervention (at 6 months CA) and at 18 months CA with a large assessment
battery including instruments to monitor neurological, motor, cognitive and
functional development.
At the level of the RCT only a minimal advantage of COPCA intervention was
found on cognitive development. The study showed that the contents of COPCA
intervention partially overlaps with that of TIP, a situation which interferes
with the RCT-design of the study. Additional process analyses of the contents
of the intervention revealed that some positive associations were found between
characteristics of COPCA intervention and developmental outcome at 18 months.
This suggests that it takes time before a beneficial effect of COPCA-approach
emerges. Therefore we are interested in the long-term effects of early
intervention.
Study objective
To evaluate the long-term effects of early intervention in high-risk infants on
the basis of the VIP-project.
Study design
This study is a follow-up study of the VIP project (MEC 98/06/106).
Duration: data-collection July 2011 * November 2011; data-analysis November
2011 * April 2012.
Setting: VIP-project, n= 46 children. The infants had been recruited at the
neonatal intensive care unit of the UMCG. Intervention was carried out in the
infant*s home and coordinated by the UMCG-team. The current evaluation will be
carried out by the UMCG-team. Caregivers will be interviewed by phone and
questionnaires will be sent by mail.
Intervention
COPCA (Coping with and caring for infants with special needs - a family
centered program) versus Traditional Infant Physiotherapy (TIP).
Study burden and risks
No risks is associated with participation in the follow-up study.
The burden of the study: interviews will be carried out by phone and
questionnaires will be filled in by parents at home. Costs/burden of
parents/researchers concern mainly about an investment of time.
Hanzeplein 1
9713 GZ Groningen
Nederland
Hanzeplein 1
9713 GZ Groningen
Nederland
Listed location countries
Age
Inclusion criteria
Infants and their families who participated in the VIP project are eligible for this follow-up study.
In the VIP project were infants included who presented definitely abnormal general movements at ten weeks corrected age, which indicates that they were at risk for developmental disorders.
Exclusion criteria
Infants with severe congenital anomalies, such as serious congenital heart disorders, and infants whose caregivers had an inappropriate understanding of the Dutch language were allready excluded in the VIP project.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | ISRTCN52740878 |
| CCMO | NL34198.042.10 |