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

Sorlandet Hospital HF

Status: Active, not recruiting

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

Treatments: Other: Habilitation as usual; Other: Program Intensified Habilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT05093777

KlinBeForskSkranes

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 2 to 7 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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90 participants in 2 patient groups

Intervention group

Experimental group

Description:

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".

Treatment:

Other: Program Intensified Habilitation

Other: Habilitation as usual

Control group

Other group

Description:

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").

Treatment:

Other: Program Intensified Habilitation

Other: Habilitation as usual