The aim of this project is to investigate a parent-mediated treatment method targeting sensory processing difficulties thereby improving the emotion regulation difficulties and quality of life of the child and its family.
ID
Source
Brief title
Condition
- Developmental disorders NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
• Emotional regulation capacities of the child using The Emotion Dysregulation
Index (EDI) (Samson et al., 2013).
• Quality of life of the child using the Pediatric Quality of Live Inventory
(PedsQL) (Varni et al., 1998).
Secondary outcome
• Adaptive functioning using the Vineland Screener 0-6 years (Scholte et al.,
2008) is completed by parents during the intake process and two times more, to
asses a short-term and long-term adaptive functioning level of the child.
• Sensory processing difficulties using the Sensory Profile-NL-2 (SP-NL-2)
(Dunn, 2002).
• Parental burden based on the Opvoedingsbelasting Vragenlijst (OBVL)
(Vermulst, Kroes, De Meyer, Nguyen, & Veerman, 2015).
• Quality of life of the parents using the Pediatric Quality of Live Inventory
Family Impact Module (PedsQL-FIM) (Varni et al., 1998).
• Parental sensitivity and co-regulation using the Parent-Infant/Toddler Coding
of Interaction - Preschool (PInTCI-P) (Pijl et al., 2018).
• Last, parental level of satisfaction is rated on a 5-point Likert Scale
short-term post-intervention, using a 20-item custom made questionnaire.
Background summary
Clinical observations and scientific research show that parents referred to
specialized mental health care often ask professional support regarding sensory
processing difficulties of their young child. It is well established that
sensory processing difficulties can have a profound negative impact on a
child*s functioning (Posar, 2018) which may continue later on in life. While
increasing the risk for emotional regulation problems, social withdrawal and
impaired quality of life, it also effects participation in society such as
work and leisure activities (Benen Demchick, Goldrich Eskow, & Crabtree, 2014;
Costa-López, 2021; Schaaf, Toth-Cohen, Johnson, Outten, & Benevides, 2011).
Children may be hyper- and/or hyporeactive to sensory stimuli or both at
different times, which makes it difficult for parents to understand and
interpret their child*s signals and respond adequately. Importantly, at this
point no evidence-based treatments are available that focus on young children
with sensory processing difficulties.
Study objective
The aim of this project is to investigate a parent-mediated treatment method
targeting sensory processing difficulties thereby improving the emotion
regulation difficulties and quality of life of the child and its family.
Study design
Given the expected heterogeneity in our study population, an experimental
single-subject design is used in this study (A1-B-A2 design) (Backman et al.,
1997) to investigate this intervention.
Intervention
The intervention consits of an e-learning, parent groups, and individual
parent-child sessions (home visits).
Study burden and risks
Nature and extent of the burden and risks associated with participation,
benefits, and group relatedness: Participants (parents/caregivers and children)
are expected to benefit from the treatment. The risks associated with
participating in the study were considered negligible and the burden associated
with participation was estimated to be low.
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Reinier Postlaan 12
Nijmegen 6525 GC
NL
Listed location countries
Age
Inclusion criteria
-Age between 0-7 years old.
-Meeting the decision criteria need for highly specialized mental health care,
based on the Decision
Tool of Karakter Young Child Center.
-Evident sensory processing difficulties, with hyperreactivity or both hyper-
and hyporeactivity to
sensory stimuli, based on the information collected during the intake process
and the SP-NL-2
(Dunn, 2002) questionnaire and interview, the latter two completed within 3
weeks after completion
of the intake process both by a member of the research team.
Exclusion criteria
-No completed or ongoing treatment at Karakter for parents/primary caregiver or
child
-Children with only hyporeactivity to sensory stimuli are excluded, due to the
use of habituation
techniques.
-Unable - although support¬ - to respond to questions (parents)
-Insufficient mastery of Dutch language (parents)
-Trauma-related disorders/complaints for which trauma treatment is directly
indicated in the child
-Attachment problems that meet the classification criteria for an attachment
disorder according to
the Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5).
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 | NL85666.091.23 |