Brain Injuries, Cerebral Palsy, Empowerment, Motor Skills Disorders, Parent-Child Relations, Parenting
Conditions
Keywords
brain injury, cerebral palsy, motor disability, GMFCS level, Pedi-Cat, Family Empowerment scale, Parenting stress index
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.
Interventions
OTHERHabilitation as usual
When the participants are not joining the study year containing the intervention program, they will be offered habilitation services "as usual" administered by the primary health care services in the local community.
OTHERProgram Intensified Habilitation
The program is based on a holistic and family-centered concept, which acknowledges parents as experts on their child's abilities and needs. The program involves both parents and local professionals, and includes goal setting and goal-directed treatment targeted to the needs of the individual child. The program lasts for about one year and contains three in-patient group sessions over 2 weeks. In between the children are receiving individualized home training programs at home and in pre-school/kindergarten. The children train on a daily basis, both during the inpatient sessions and in the home setting.
Sponsors
Sorlandet Hospital HF
Haukeland University Hospital
St. Olavs Hospital
University Hospital of North Norway
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Blinded evaluation by independent researchers at baseline, at 12 months and at 24 months.
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.
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) | Change from baseline measure at 12 months and after 24 months | Primary evaluation measure for the child |
| Change in Family Empowerment Scale (FES) | Change from baseline measure at12 months and after 24 months | Primary evaluation measure for the parents |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Gross motor function measure (GMFM-88) | Change from baseline measure at 12 months and after 24 months | Secondary evaluation measure for the child |
| Change in Parenting Stress Index (PSI) | Change from baseline measure at 12 months and after 24 months | Secondary evaluation measure for the parents |
Countries
Norway
Contacts
PRINCIPAL_INVESTIGATORJon Skranes
Sørlandet Hospital
Outcome results
None listed