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

Cerebral Palsy Clinical Trial

— PIHMulti  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05093777
• Other study ID #: KlinBeForskSkranes
• Status: Recruiting
• Phase: N/A
• Start date: October 10, 2021
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Sorlandet Hospital HF
• Contact: Jon S Skranes, MD PhD
• Phone: 99390285
• Email: joskra[@]online.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Program 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.
• Habilitation 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.

Locations

Country	Name	City	State
Norway	Sørlandet Hospital	Kristiansand

Sponsors (4)

Lead Sponsor	Collaborator
Sorlandet Hospital HF	Haukeland University Hospital, St. Olavs Hospital, University Hospital of North Norway

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Change in Family Empowerment Scale (FES)	Primary evaluation measure for the parents	Change from baseline measure at12 months and after 24 months
Secondary	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
Secondary	Change in Parenting Stress Index (PSI)	Secondary evaluation measure for the parents	Change from baseline measure at 12 months and after 24 months