Program Intensive Habilitation (PIH) for Young Children With Early Brain Damage

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of a Norwegian Model of an Intensive Habilitation Program for Young Children With Early Brain Damage - a Multicentre Randomized Controlled Trial.

Conditions
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Brain Injuries, Cerebral Palsy, Motor Skills Disorders, Empowerment, Parent-Child Relations, Parenting

Intervention / Treatment
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* Other: Program Intensified Habilitation
* Other: Habilitation as usual


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Half of the study participants will be randomized to the intensive habilitation program the first year of program. The second year of program this group of participants will be offered habilitation as usual. | Other: Program Intensified Habilitation<br>* 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.<br>* Other names: PIH Multi;Other: Habilitation as usual<br>* 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.<br>* Other names: Control;|
| Other: Control group<br>Half of the study participants will be randomized to treatment as usual the first year of program, then offered the intensive program during the second year (stepped wedge design). | Other: Program Intensified Habilitation<br>* 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.<br>* Other names: PIH Multi;Other: Habilitation as usual<br>* 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.<br>* Other names: Control;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT) | Primary evaluation measure for the child | Change from baseline measure at 12 months and after 24 months | 
| Change in Family Empowerment Scale (FES) | Primary evaluation measure for the parents | Change from baseline measure at12 months and after 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Gross motor function measure (GMFM-88) | Secondary evaluation measure for the child | Change from baseline measure at 12 months and after 24 months | 
| Change in Parenting Stress Index (PSI) | Secondary evaluation measure for the parents | Change from baseline measure at 12 months and after 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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motor disability, brain injury, cerebral palsy, GMFCS level, Pedi-Cat, Family Empowerment scale, Parenting stress index