The primary aim of the study is to improve the oral cleanliness of young high caries active children by a HAPA-based intervention to improve the brushing behaviour of parents in their children. Therefore, the effect of the HAPA-based intervention is…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
cariës, mondgezondheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. the level of dental plaque in children
2. the HAPA score per construct
Secondary outcome
1.caries incidence in deciduous and permanent dentition
2. the cost-effectiveness
3. the acceptance and experiences of parents
4. the applicability and experiences of the dental team
5.. Action Planning, Coping Planning, Action Control
Background summary
Caries is the most common non-communicable disease with high prevalence. It
seems that the parents of high caries risk children to not benefit from
conventional prevention programmes. A prevention programme that is based on
theory from health behavioural science could be beneficial for the oral health
of children. The Health Action Process Approach (HAPA) is a model from health
behavioural sciences that emphasizes bridging the intention behaviour gap.
Hypotheses:
It is expected that HAPA-based prevention programme will result in lower level
of dental plaque, higher scores on the HAPA constructs, higher brushing
frequency, less caries, better quality of life and more cost-effectiveness than
a conventional prevention programme in young high caries risk children, after
12 months, and in less caries after 24 months.
Study objective
The primary aim of the study is to improve the oral cleanliness of young high
caries active children by a HAPA-based intervention to improve the brushing
behaviour of parents in their children. Therefore, the effect of the HAPA-based
intervention is compared with conventional prevention after one, three, six and
twelve months on the following variables:
* the level of dental plaque in the children
* the mean scores of the parents on the social cognitive constructs from the
HAPA model, being *action self-efficacy*, *risk perceptions*,* outcomes
expectancies*, *intention*, *action planning*, *coping planning*, *coping
self-efficacy* en *action control*.
The secondary aim is to compare the control group with the interventiongroup on:
1. caries incidence in primary and permanent dentition after 12 and 24 months.
2. the cost-effectiveness during the study period
3. the acceptance and experience of the dental staff, practitioners, parents
and children during the study period
4. the quality of life of the children after 12 months.
Study design
This is a multicenter patient randomised clinical intervention study with two
parallel arms: one intervention group and one control group. Besides the usual
restorative dental care both groups receive conventional prevention as usual
care, based on the Ivoren Kruis. Additionally in the intervention group the
HAPA-based-model is applied the improve the preventive oral health behavioral
change, by using action planning, coping planning and action control (mobile
website).
The study is partially blind (examiner). The primary end point is one year
after start intervention. A secondary end point for caries incidence is two
year after start intervention. Parents, investigators are not blind for the
intervention as they receive and give the intervention. Only desk clerk,
examiners of the dental and caries, data processors and primary investigator
are blind for the allocation.
Intervention
Parents in both groups receive five conventional prevention interviews per year.
Parents in the intervention group will focus on action planning, coping
planning and action control during each prevention interview. In addition,
parents in the intervention group receive a reminder of their brushing goals
and register their brushing behavior on the mobile website (action control)
every day.
Study burden and risks
Parents in both groups are expected to benefit from conventional prevention and
parents in the intervention group are expected to benefit more from prevention.
There are no known risks associated with conventional prevention or HAPA
prevention.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
Parents/caregivers
*of children 4 to 8 years old with ASA 1 of 2
*who have signed the informed consent
who have a proper understanding of the Dutch language to fill out the
questionnaire
* who have a proper understand fo the Dutch language to receive the
intervention
Exclusion criteria
Parents/caretakers
of children with syndromes
of children who are not treatable because of behaviour managment problems
of children with enamal abnormalities other than caries
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 |
|---|---|
| CCMO | NL72154.029.20 |