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Completed

NCT Number: NCT05093777

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

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.

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Key information

Conditions

Brain Injuries Behavior Brain Damage, Chronic Brain Diseases Central Nervous System Diseases Cerebral Palsy Craniocerebral Trauma Empowerment Mental Disorders Motor Skills Disorders Nervous System Diseases Neurodevelopmental Disorders Parent-Child Relations Parenting Social Behavior Trauma, Nervous System Wounds and Injuries

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sørlandet Hospital

Kristiansand, 4626, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Program Intensified Habilitation

Other

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.

Other names: PIH Multi

Habilitation as usual

Other

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.

Other names: Control

Primary outcomes

  1. Change in Pediatric Evaluation of Disability Inventory - Computer Adaptive Test (PEDI-CAT)

    Time frame: Change from baseline measure at 12 months and after 24 months

    Primary evaluation measure for the child

  2. Change in Family Empowerment Scale (FES)

    Time frame: Change from baseline measure at12 months and after 24 months

    Primary evaluation measure for the parents

Secondary outcomes

  1. Change in Gross motor function measure (GMFM-88)

    Time frame: Change from baseline measure at 12 months and after 24 months

    Secondary evaluation measure for the child

  2. Change in Parenting Stress Index (PSI)

    Time frame: Change from baseline measure at 12 months and after 24 months

    Secondary evaluation measure for the parents

Sponsors and collaborators

Lead sponsor

Sorlandet Hospital HF

Other Gov

Collaborators

  • Haukeland University Hospital
  • St. Olavs Hospital
  • University Hospital of North Norway

Registry information

Official study title

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

Acronym: PIHMulti

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
Oct 26, 2021
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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