Clinical trial NCT05093777: Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage
Official title: Evaluation of a Norwegian Model of an Intensive Habilitation Program for Young Children With Early Brain Damage - a Multicentre Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Brain Injuries
Cerebral Palsy
Motor Skills Disorders
Empowerment
Parent-Child Relations
Parenting
Keywords: brain injury
cerebral palsy
motor disability
GMFCS level
Pedi-Cat
Family Empowerment scale
Parenting stress index
Lead sponsor: Sorlandet Hospital HF
Sponsor class: OTHER_GOV
Collaborators: name: Haukeland University Hospital
name: St. Olavs Hospital
name: University Hospital of North Norway
First posted: 2021-10-26
Enrollment: 90
Sex: ALL
Minimum age (years): 2
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Randomized controlled trial (RCT) with blinded evaluation by independent researchers at baseline, at 12 months and at 24 months. A stepped-wedge design will be applied so that all study participants eventually will be offered the intervention program. Those who are randomized to control group in the first year of study, will be offered intensive training during the second year, and vice versa.
Primary purpose: TREATMENT

Brief summary: By longitudinal, prospective research in children with neurodisabilities including severe motor impairments and their parents to explore the beneficial effects of participating in an intensive habilitation program on the child's adaptive functioning and parental empowerment in order to treat and reduce the consequences of early brain damage.

Detailed description: Evidence-based knowledge about the effects of intensive training programs for children with severe early brain damage is limited since research on this topic has methodological weaknesses and shows conflicting results. As intensive training programs require extensive efforts from the child, parents and professionals and represent major costs, the importance of scientifically proven effects is considerable. This research project aims to measure the effects of an intensive habilitation program for young children with severe early brain damage on the child's adaptive, motor, language and social functioning and on parental empowerment, family functioning and stress. In this randomized controlled trial (RCT) 90 children will be divided into an intervention group participating in a Norwegian developed program of intensified habilitation of 12 months duration and a control group, who will receive "services as usual" during the same time period. Between-group analyses will then be performed. Due to a stepped wedge design, the control participants will then be offered training in year two of participation. Within-group analysis of results before and after training will then be performed for all participants. Standardized measures with high responsiveness in documenting intervention effectiveness will be used as primary outcome measures. Intensive training groups will be offered in all Health Regions in Norway and if successful be implemented as standard clinical practice.

Eligibility criteria: Inclusion Criteria:

* age 2 - 6 years at the start of the program
* a diagnosis of severe cerebral palsy or similar motor disability of non-progressive etiology (GMFCS level IV-V),
* being able to participate in group sessions
* having parents who want to take an active part in their child's training
* least one of the parents must speak fluent Norwegian or English.

Exclusion Criteria:

* children with progressive disorders
* co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.

Primary outcomes:
measure: Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)
timeFrame: Change from baseline measure at 12 months and after 24 months
measure: Change in Family Empowerment Scale (FES)
timeFrame: Change from baseline measure at12 months and after 24 months
Secondary outcomes:
measure: Change in Gross motor function measure (GMFM-88)
timeFrame: Change from baseline measure at 12 months and after 24 months
measure: Change in Parenting Stress Index (PSI)
timeFrame: Change from baseline measure at 12 months and after 24 months
Other outcomes:
Locations:
city: Kristiansand
country: Norway
facility: Sørlandet Hospital
Study officials:
affiliation: Sørlandet Hospital
name: Jon Skranes
role: PRINCIPAL_INVESTIGATOR
References: