The first objective of this study is to gain insight in which neurocognitive and neurobiological processes underlie the development of externalizing behavior (in specific aggressive behavior) in the first two years of life. The second objective is…
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Source
Brief title
Condition
- Other condition
Synonym
Health condition
het onderzoek richt zich niet op bepaalde aandoeningen maar meer op een verzameling van factoren die maken dat een (aanstaande) moeder verminderd in staat is om zich goed aan te passen aan het moederschap, dat kunnen problemen zijn in de psychische gezondheid, financiele situatie, huisvesting, sociale steun, levensstijl, werkloosheid, uitval in het onderwijs en dergelijke
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The assessments will focus on (1) maternal self-efficacy in the nurturing role,
life style and psychopathology, (2) the neurobiological (HPA axis and ANS
functioning), neurocognitive (e.g. executive functioning) and socio-emotional
development (e.g precursors to Theory of Mind, emotional reactivity and
regulation) of the child, and (3) the quality of parenting and the parent-child
relation.
Secondary outcome
A secondary aim of this study is to evaluate the (behavioral, personality-,
socio-demographic) profile of mother*s who benefit most from the intervention
versus mothers who do not benefit or benefit less from the intervention. These
secondary study parameters are maternal parameters such as Psychopathology/
mental health, Life style (alcohol, drugs and smoking), Personality,
Intelligence, Demographics (e.g. work status, education, relationship status).
Background summary
Aggressive behavior starting in the early development of life has a poor
prognosis. A large body of research on the etiology of antisocial behavior has
focused on the role of environmental factors. A more recent area of research
has focused on neurobiological and neurocognitive factors involved in the
development of aggressive behavior. However, most of this research involves
children in which aggressive behavior is already part of their behavioral
repertoire. The focus of this study is on the first two years of life, when
behavioral problems (i.e. aggressive behavior) first appear in the child*s
behavioral repertoire. To prevent social, emotional and cognitive problems
later in development and to prevent long lasting and expensive treatment
programs, it is important to develop evidence-based treatment and preventive
programs.
Study objective
The first objective of this study is to gain insight in which neurocognitive
and neurobiological processes underlie the development of externalizing
behavior (in specific aggressive behavior) in the first two years of life. The
second objective is to examine the effects of an intensive home visiting
program for first time mothers at risk on child neurocognitive and
neurobiological functioning, and the working mechanisms underlying the effects
of this program. A secondary objective of this study is to evaluate the social
and cognitive profile of mothers who benefit most versus mothers who benefit
less from the program.
Study design
Randomized control intervention study, three groups (one intervention and two
control groups). Subjects assigned to the high risk group (presence of > 1 risk
factor) are randomly allocated to either the intervention group (N=60) or the
(high risk) control group (N=100). Subjects in the low risk group (presence of
<2 risk factors) will serve as (low risk) normal control group (N=100). The
study consists of five measurement moments across three years, at the 27th week
of pregnancy and 6, 12, 20, 30 and 45 months post partum.
Intervention
Half of the high risk subjects will receive an intervention. The intervention
consists of home visits, starting by the 28th week of pregnancy with weekly
visits and continuing through the infant*s first year. The home visits are then
tapered to every other week through the child*s second year. During the home
visits, the coaches carry out three major activities: (a) stimulating maternal
reflective functioning, (b) promoting secure attachment, (c) attention for
mental and physical health in mother and child, and child*s development. The
control subjects will receive the casual care.
Study burden and risks
Participation includes five assessments over a three year period (three home
visits (T1, T2, T4), and three visits to the Babylab (T3, T5, T6)). The
assessments will last no more than two and a half hours. There are no known
risks associated with participating in this study and the intervention. The
physical burden for the children participating is minimal and will consist of
taking several saliva samples (at T3, T5 and T6) and having attached to their
bodies the heart rate and respiration monitoring equipment (at T2, T3, T5 and
T6). Serval saliva samples will also be taken from the mothers (at T3 and T5).
The most important benefits for mothers and children in the intervention group
are increased knowledge of early child development in general and in particular
the mother learns to understand her child*s behavior, feelings and needs, and
to adequately respond to her child. In addition, the mother is given help with
the organization of her own life, home, social network, education and work
leading to a more positive environment for mother and child. For subjects who
participate in this study but not in the intervention, there are benefits from
the potential knowledge gained from this study. They are stimulated to actively
think about their role as a (becoming) mother and the development of their
child. In this way, and by actively involving the mothers in the child
assessments, they may gain more insight in the development of their child.
Wassenaarseweg 52 2333AK Leiden
Leiden 2333 AK
NL
Wassenaarseweg 52 2333AK Leiden
Leiden 2333 AK
NL
Listed location countries
Age
Inclusion criteria
- Aged between 17 and 25 (at recruitment/consent)
- Having a first child
- Recruited no later than 27th week of the pregnancy
- Competence in Dutch language
Regarding the assignment to the high risk group, the following list of criteria is used. A subject is assigned to the high risk group in case more than one risk factor is present:
- Unemployed
- Housing problems
- Poverty / financial problems
- Single or varying partners
- No or little social support
- Psychiatric disorder or psychosocial problems
- Substance use/abuse (alcohol, smoking, drugs)
Exclusion criteria
- Heavy drug addiction or severe psychiatric or psychotic disorder, which requires more heavy psychiatric help
- IQ < 70
- Major acute or significant chronic illness in the mother
- Disorder or syndrome in the child which will affect normal development
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL39303.058.12 |