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

NCT05093777 | Active Not Recruiting

• 1 other identifier: KlinBeForskSkranes
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

brain injury; cerebral palsy; motor disability; GMFCS level; Pedi-Cat; Family Empowerment scale; Parenting stress index

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Change in Gross motor function measure (GMFM-88)

  Change from baseline measure at 12 months and after 24 months

• Change in Parenting Stress Index (PSI)

  Change from baseline measure at 12 months and after 24 months

Study Arms (2)

Intervention group

EXPERIMENTAL

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; Other: Habilitation as usual

Control group

OTHER

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; Other: Habilitation as usual

Interventions

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.

Also known as: PIH Multi

Control group; Intervention group

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.

Also known as: Control

Control group; Intervention group

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• children with progressive disorders
• co-morbidity like autism spectrum disorder, severe visual and hearing impairments or intractable epilepsy that worsen with physical activity.

Sponsors & Collaborators

• Sorlandet Hospital HF: lead
• Haukeland University Hospital: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator

Study Sites (1)

Sørlandet Hospital

Kristiansand, 4626, Norway

Location

MeSH Terms

Conditions

Brain Injuries; Cerebral Palsy; Motor Skills Disorders; Empowerment

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Brain Damage, Chronic; Neurodevelopmental Disorders; Mental Disorders; Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Jon Skranes

  Sørlandet Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinded evaluation by independent researchers at baseline, at 12 months and at 24 months.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor dr med

Model Details: 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.

Study Record Dates

• First Submitted: September 28, 2021
• First Posted: October 26, 2021
• Study Start: October 10, 2021
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)