A non-traditional complex intervention for the treatment of paediatric sleep problems.

Sleep problems and insomnia among infants (aged 6 months -1 year), toddlers
(aged 1-3 years) and (pre-)school children (aged 3-5 years) are highly
prevalent in paediatric care, which can seriously compromise quality of life of
both children and their families. Current prevalence estimations of insomnia
based on the first five years of life range from 10-30% among the general
paediatric population. 25-50% of infants and toddlers older than six months
have frequent night wakening*s, 10-15% of toddlers have bedtime resistance and
15-30% of preschool children suffer from daytime sleepiness and have wakening*s
at night. Most sleep problems are temporarily but they have a tendency to
develop at the long-term into insomnia.
Paediatric insomnia tends to persist throughout childhood and adolescence and
is associated with a higher prevalence of negative functional outcomes, such as
cognitive and behavioural problems. It might also result in an increased risk
of obesity and other negative metabolic consequences later in live.
Most of the interventions for paediatric sleep problems and insomnia, in
particular sleep hygiene and behavioural interventions, are deemed effective.
In 2017 the Dutch guideline *Healthy sleep and paediatric sleep problems* was
published, to offer professionals in paediatric care a standardised diagnostic
and intervention model. The guideline offers a stepped care intervention model,
introducing sleep hygiene interventions to create optimal sleep conditions. In
case of insufficient responding, behavioural interventions are offered.
Referral to a specialised sleep centre is advised in case of persisting sleep
problems not responding to sleep hygiene and behavioural interventions.
The number of children or their parents who do not profit from the recommended
interventions remains unclear and evidence of long-term effectiveness is still
missing.
In this study we hypothesize a delayed development of the self-regulating
abilities as a underlying cause of the originating of a subtype of common sleep
problems. Self-regulating abilities, including self-soothing, promote the
possibility to fall asleep and are of high importance for the development of
autonomous sleeping skills. Sleep problems in early infancy (2-6 months) are
negatively correlated with a delayed maturation of various
(neuro-)physiological processes such as those regarding the cardiorespiratory
system, the digestive system and the developing brain functioning. Persisting
sleep problems in infants above the age of six months often originate from an
insufficient developmental process of one or more domains of
(neuro-)physiological functioning. The physical inconvenience related to the
disfunctioning maturing process is disruptive to the state control of the child
and may cause signs of dysregulation (fuzziness, irritability and poor
self-calming).
Initial adequate parental strategies to relief the physiological inconvenience
may result in a delayed development of self-regulating abilities and/or the
origin and maintenance of dysfunctional sleep habits. Parents not responding to
the guideline often prefer *sensitive parenting* and/or experience the
behavioural interventions as stressful. The stress provoking effect on parents
and child practicing some of the behavioural interventions (in particular
unmodified extinction) remains unclear.
The guideline *Healthy sleep and sleep problems* does not address to the
underlying disruptive (neuro-)physiological regulation. We hypothesize in this
study that intervening to support the maturing process of the disfunctioning
(neuro-)physiological process might enable good functioning and will contribute
to the treatment of sleep problems. Early intervening can be useful to prevent
the development of insomnia.
In a Dutch paediatric practice a personalised integrative sleep intervention is
developed and practised. Clinical effectiveness is available, scientific
evidence is missing.
This study will compare the effects of the treatment as usual to a complex
intervention type. A complex intervention can be described as an intervention
containing several interacting components, with a range of possible outcomes
and a variability in the target population. The interacting components comprise
the state of development of the self-regulating abilities of the child, the
parental pedagogic possibilities and preferences and the environmental factors
related to the sleep problem. Herbal treatment, massage interventions, sensory
information interventions, parental counselling and dietary advise are possible
elements of the complex intervention.
This two staged study, composed of a feasibility study and a randomised
controlled trial (RCT), will evaluate the effectiveness of an used complex
intervention for paediatric sleep problems in the paediatric field compared to
treatment as usual. The feasibility study (ABR form) only examines the
feasibility of the research procedures, the burden on parents and child with
regard to the measuring instruments and the interest in participating in the
study. The feasibility study does NOT investigate the efficacy of the complex
intervention.
*

Assessing the feasibility of the research procedures, the burden on
participants, the degree of dropout and reason, the interest in participating.

What is the main treatment effect for parents / carers motivating them to
participate in this study?
• Is it feasible for parents / carers to fill in all measuring instruments
during the study?
• What is the number of students who drop out and for what reasons?
• Do participating professionals fill in all questions of the TIDieR guideline,
and if not for what reasons?
• What is the average number of participants recruited in a week? And where
does the reference come from?
• Are parents / carers willing to accept the randomization procedure in the
RCT?

It concerns a phased study design, in which in phase 1, the feasibility study,
the feasibility of the study design is investigated without a control group.
24 children are included.

Stage 1:
Complex intervention of paediatric sleep problems, a combination of two or more
intervention types; herbal treatment, massage interventions, sensory
information interventions, parental counselling and dietary advise.

Stage 2:
Experimental group: complex intervention of paediatric sleep problems
Control group: treatment as usual (TAU) according to the Dutch guideline
*Healthy sleep and paediatric sleep problems*

The following items of risk associated with participation are assessed in the
feasibility study and RCT:
The deviation of the Dutch guideline *Healthy sleep and paediatric sleep
problems* may result in a treatment effect which is less predictable.


The burden to comply with the data collection procedures for parents is to fill
out all questionnaires during the four measuring waves over a period of 18
weeks for a total of approximately 3,5 hours.

The possible benefits associated with participation of the study are:
A reduction of sleep problems
A more comprehensive view and guidance on parental and environmental sleep
factors
A guidance to handle parental stress in relation to paediatric sleep problems
and
The contribution to the development of a scientific basis of the complex sleep
intervention

The risks for carrying out this study with minors is considered negligible due
to the reason the complex intervention is an used intervention and is common
practice in the Kindertherapeuticum for children with sleep problems. All
participating professionals can be considered as experts, screened in advance
on expert knowledge and available experience with the participating
intervention groups.