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Intervention SENSory regulation Early life

Intervention SENSory regulation Early life - iSENSE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57172
Enrollment
20
Registered
2024-10-15
Start date
2024-05-01
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sensory atypicalities

Interventions

The intervention consits of an e-learning, parent groups, and individual parent-child sessions (home visits).

Sponsors

GGZ instellingen / Psychiatrische Ziekenhuizen
Lead Sponsor

Eligibility

Age
2 Years to 64 Years

Inclusion criteria

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

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 outcomes

Primary

MeasureTime frame
• 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

MeasureTime frame
• 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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)