The aim of this study is to evaluate the feasibility of the E-TOP module for both VP infants as an addition to the TOP program as well as for MP infants in an adapted TOP program.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
ontwikkelingsproblemen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The process evaluation for the feasibility includes the online use of the E-TOP
module and the adapted TOP program for MP infants and parental experiences
with the E-TOP module. and the adapted TOP program.
Secondary outcome
Outcomes measures include the questionnaires: Maternal self-efficacy in the
Nurturing Role (SENR), Parental Reflective functioning Questionnaire (PRFQ),
Massie Cambell scale of Mother-Infants Attachement indicators during Stress
(ADS), Ages and Stage Questionnaire: Socio-Emotional, Second Edition
(ASQ:SE-2), Distress Thermometer for Parents (DT-P), . Parent-child interaction
will be evaluated by the Massie Cambell Scale of Mother-Infants Attachement
indicators during Stress (ADS). Motor development will be assessed by the
Alberta Infant Motor Scale (AIMS). Parental experiences with the E-TOP and
adapted TOP program will be assessed using questionnaires as well as by
semi-structured interviews.
Background summary
Very preterm (VP) and moderate preterm (MP) born infants are vulnerable and at
risk for developmental problems. In the Netherlands, the TOP program, a
post-discharge responsive parenting program, is part of routine care for VPT
infants in the first year. Despite this support, parents still have more
information needs. More parental knowledge of development is associated with
better outcomes. Parents of MP infants do not receive the TOP program, and also
have information needs.
Study objective
The aim of this study is to evaluate the feasibility of the E-TOP module for
both VP infants as an addition to the TOP program as well as for MP infants in
an adapted TOP program.
Study design
A pilot feasibility study with a pretest-post test design
Intervention
E-TOP module, families will receive information regadring prematurity, en de
consequences for e.g. feeding, sleeping, crying, the behaviour and development
of pretermborn infants, and parenthood after preterm birth. Families with an MP
infant will receive additionally the adapted TOP program consisting of 6 home
visits by a TOP interventionist in the first 6 months.
Study burden and risks
Parents fill in three questionnaires at baseline, and four questionnaires at 6
months follow up. In addition, the TOP paediatric physical therapist will
assess at the post-test motor development with the AIMS (already standard for
the VPT infants in the TOP program). mother-child interaction will be assessed
at pre and posttest using a videotaped observation of a daily situation of
approximately 5 minutes, using the ADS.
We hypothesize that the E-TOP module added to the (adapted) TOP program has a
positive effect on parental knowledge, parental satisfaction, parental
responsiveness and thereby on the development of preterm infants, whereas the
risk for children is neglible.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
VP group: participating in the TOP program
MP group: born between 32-34 weeks of gestation
Exclusion criteria
infants with severe congenital abnormalities of parents with severe mental
illness
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 |
|---|---|
| ISRCTN | ISRCTN65709138 |
| CCMO | NL78996.018.21 |