The proposed study has 2 main aims: 1) Understanding the complex interplay of determinants of parenting and examining how specific parenting styles explain associations between parent characteristics (such as personality or mental and physical (ill…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
- Psychiatric and behavioural symptoms NEC
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The TRAILS study is an extensive database on the basis of which different
researchers answer different scientific questions, rather than a study with
primary and secondary outcome measures. We had to make choices, and the focus
is on measuring personality/temperament in both parents and child, additional
early cognitive development in the child (previously also done in parents when
they were 11 and 18 years old) and environmental proxies, i.e. parenting /
parent-child relationships on the one hand and other important aspects of the
environment (such as SES and serious life events) on the other hand. In the
research protocol we have given global examples of the type of research
questions that can be answered in TRAILS - Tracking the Next Generation.
However, for each study carried out in TRAILS there are primary and secondary
outcome measures that are specified in advance, per research question, in a
publication plan. Studies are only carried out after a positive assessment of
this publication plan (based on the quality of the research question and its
elaboration, and the feasibility of answering the question in TRAILS) by the
TRAILS management team. Researchers thus commit themselves to answer all the
questions included in their publication plan, regardless of whether the
association(s) found are significant or not. These procedures that need to be
followed for all studies conducted in TRAILS are established to guarantee the
quality of the research in TRAILS and to prevent "fishing" in the data as well
as publication of only positive (i.e. statistically significant) findings.
Therefore, although it is clear per research question which variable is the
primary outcome measure, and whether there are any secondary outcome variables,
the multitude of research questions in TRAILS makes it impossible to answer
this question about primary and secondary research variables in general. This
is the background on the basis of which we filled in N/A (just as we did in
previous TRAILS research protocols assessed by the CCMO).
We also emphasized the main concepts that are central to the study, on the
basis of which the instruments were chosen, in the research protocol. We do not
measure things that we consider to be of secondary importance. The choice of
personality/temperament in both parents and child, additional early cognitive
development in the child (previously also done in parents when they were 11 and
18 years old) and the environmental proxies such as upbringing and SES and
serious life events were chosen after careful consideration (in which other
subjects and associated instruments "did not make it"). In that sense, we have
no secondary research variables/outcome measures.
Secondary outcome
N/A, see text under primary research variables/outcome measures.
Background summary
We know from prior research that parental characteristics, such as personality
or mental (ill-)health, are important predictors of parenting which interact
with the social context to influence developmental outcome in the children.
However this knowledge is still very general and much more precision is
needed.
First, few if any studies comprehensively examined this interplay using
detailed information about the parents and their social contexts as predictors
of variation in parenting. Second, parenting and parent-child relationships,
in turn, play an important role in child development and are assumed to
function as mechanism between parent characteristics and child outcomes. Yet,
again, there a few comprehensive studies to substantiate this. Parenting and
parent-child relationship are an important target for prevention or treatment
in relation to unfavourable developmental outcomes in children, therefore,
research needs to determine these pathways. In addition, it is well known
personal characteristics (e.g. personality) interact with the social context
to affect mental and physical (ill-)health.
Unknown, however, is whether and how these so called person x environment
transactions affect the next generation. As argued, parenting and parent-child
relations are key targets for prevention and treatment efforts that are aimed
at improving child adaptation. Thus, studying the transactions of parental
characteristics, parenting, and the social context allows us to understand in
much greater detail under which conditions particular parenting styles are
especially maladaptive. Such a detailed understanding provides a solid
knowledge base for developing personalized and contextualized prevention and
treatment efforts: i.e., what works well for which child, given the parental
and environmental context.
Abovementioned applies to the ROAD study as well, within the context of a child
with ultra-high risk for developing ADHD, given that at least one of the
parents has ADHD. Gained knowledge will be utilized for the development of a
screening tool to identify children at high risk of developing ADHD.
Study objective
The proposed study has 2 main aims:
1) Understanding the complex interplay of determinants of parenting and
examining how specific parenting styles explain associations between parent
characteristics (such as personality or mental and physical (ill-)health) and
child developmental outcomes.
2) Exploring whether and how transactional (person x environment) models of the
development of mental and physical (ill-)health reach into the next generation
and are predictive of child developmental outcomes.
The ROAD study has the same aims within the context of an ultra-high risk for
the child to develop ADHD.
Study design
TRAILS participants (n=2700) will be contacted 4 times per year (every 3
months) by email. In this email they will be asked whether they or their
partners are pregnant. To answer this question participants will be requested
to click on a link indicating whether they are, or are not, expecting a child.
Participants who indicate that they expect a child are then contacted by phone.
Participants are asked to confer with their partners and decide if they want to
participate in the current add-on study. Additional information on the study,
by mail or telephone, will be provided to the partner if requested.
Participants who agree to participate in the study will be invited 5 times to
participate: during pregnancy until the child is 3 months old, when the child
is 3 months old, 30 months old, 54 months old and 78months old.
At T1, during pregnancy until the child is 3 months old, participants will be
asked to fill in, weekly, a few questions on their well being (duration 1
minute).
In addition, when the baby is 3 months old, a questionnaire (max. 1 hour) will
be submitted to both parents at the end of T1 when a home visit will be paid to
observe movements of the child and the parent-child interaction (T2).
At the age of 2-3 months (VM1) and at the age of 11 months (VM2) video
recordings will be made of the parent-child interaction surrounding the child's
vaccinations. In advance, parents will be asked about their expectations, and a
week after the vaccination how it went. (This part will not be included in
ROAD).
When the child is 2,5 years old (T3) a questionnaire (max. 1 hour) will be
presented again to both parents (and any non-biological parents). Furthermore,
we will pay a home visit to observe parent-child interaction. In addition, the
child will do some short tasks to measure cognitive development. We will
collect swabs of buccal cells (i.e., conduct mouth swabs) from the child and
the biological parents.
At the age of about 4 years (VM3) video recordings of the parent-child
interaction surrounding the toddler vaccination will be made again, in the same
way as at 3 and 11 months. This time the child will also be asked how painful
the injection was using a scale of smileys. (This part will not be included in
ROAD).
At T4, when the child is 4,5 years, participants will be asked to fill in a
questionnaire (max. 1 hour) . Also the teacher will be asked to fill in a
questionnaire. Furthermore, we will pay a homevisit to do the Berkely Puppet
Interview with the child and collect swabs of buccal cells (i.e., conduct mouth
swabs) of the child and the biological parents only if this was not possible at
T3. We also will interview one of the biological parents. During the house
visit, the Disruptive Behavior Diagnostic Observation Schedule (DB-DOS) will be
administered. In this observational task, the parents will do five interactive
tasks with the child that will be recorded. The tasks are designed to assess
the child*s coping with potential everyday frustration situations, such as
having to wait for their turn to speak to the parent, coping with an unsolvable
maze, and the disappointment of initially not receiving a reward (which of
course will be given later).
At T5, when the child is 6.5 years, participants will be asked to fill in a
questionnaire (max. 1 hour) . Also the teacher will be asked to fill in a
questionnaire. Furthermore, we will pay a homevisit to do the Berkely Puppet
Interview with the child. We also will interview one of the biological parents.
During the house visit, the Disruptive Behavior Diagnostic Observation Schedule
(DB-DOS) will be administered (see 4,5 years assessment), and the short version
of the WISC-V-NL IQ test.
The same design applies to the ROAD cohort (N = 200 infants + their parents),
except that participants will not enroll from the TRAILS study but will be
newly recruited.
Study burden and risks
There are no risks involved in filling out questionnaires, or in the
observations or tasks during the home visits. It cannot be excluded completely
that during the home visits parents will be emotional given their new role as a
parent with accompanying responsibilities. We are working with a team of
research participants who are highly skilled and have been collecting data for
TRAILS for years. New research assistants are trained in dealing with emotions
appropriately and in never leaving a participant behind on his/her own in a
very difficult situation. The vaccinations are regular vaccinations; making
video recordings does not involve any additional risk.
Hanzeplein 1
Groningen 9713 GZ
NL
Hanzeplein 1
Groningen 9713 GZ
NL
Listed location countries
Age
Inclusion criteria
All TRAILS and TRAILS-CC participants, who are parent or are to become a parent
in the next ten years, except those who dropped out of the study. In addition
the babies or young children of these parents will be included.
In the ROAD cohort, at least one of the parents has ADHD and they are either
pregnant or anticipating to become pregnant.
Exclusion criteria
No participation in TRAILS
Design
Recruitment
Medical products/devices used
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 | NL47782.042.14 |