The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy

Cerebral Palsy Clinical Trial

Official title:

The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03264339
• Other study ID #: 2016/1366
• Status: Completed
• Phase: N/A
• Start date: September 7, 2017
• Est. completion date: June 7, 2021

Study information

• Verified date: September 2021
• Source: St. Olavs Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Children with cerebral palsy (CP) have life-long motor disorders caused by brain injuries which occur around birth. These children go through extensive treatment during childhood, but the treatment has generally been started late due to late diagnosis (median age 15 months). New recommendations state that the clinical diagnosis "high risk of CP" should be given before 6 months corrected age, in order to be able to intervene as early as possible, and have the best possibilities to prevent or limit the adverse neurodevelopmental consequences of brain injuries occurring around birth. Thus, there is a great need to develop evidence-based early interventions for children at high risk of developing cerebral palsy.

The Small Step program is developed at Karolinska Institutet (KI) in Stockholm, Sweden and is based upon theories of brain plasticity induced by early learning. The efficacy of the program is presently being investigated at KI. Preliminary results indicate a large individual variation in response to the program among the participating children.

The aim of the present study is therefore to explore individual responses to the Small Step Program in infants at risk of developing cerebral palsy.

The main hypothesis is that infant characteristics, such as severity of brain pathology, are associated with differential response to the program. Also, infants with absent fidgety movements and children with sporadic fidgety movements are believed to respond differently to the program.

Description:

The efficacy of the Small Step program is presently being investigated through a randomized controlled trial (NCT02166801) at Karolinska Institutet (KI) in Stockholm, Sweden. In the original project proposal for the current study, the plan was to contribute with inclusion of children from St. Olavs Hospital to the randomized controlled study initiated at KI. This project proposal has previously been approved by the Regional Ethical Committee (REK) for Medical Research in Mid-Norway (2016/1366). However, the researchers at KI have now completed the inclusion of participants for the randomized controlled study, and their preliminary results indicate that there is a large individual variation among the included participants regarding effect of the Small Step program. In agreement with the researchers at KI, it was therefore decided to change the design of the current study using Single Subject Research Design, a study design that is more appropriate to investigate individual response to treatment. The change in study design has been approved by REK (2016/1366-10).

Participation in this study is based on informed consent from the parents, and the child and the family participating in the project will be offered a potentially effective early intervention program that they would otherwise not be able to access.

The Small Step intervention program has three alternating treatment foci (B, C, and D) divided into five different steps, each lasting for 6 weeks (in total 30 weeks). The three treatment foci are Communication, Hand function and Mobility/gross motor function. The Hand function and Mobility steps will be conducted during two time-periods and the order will be randomised. Communication will have one intervention period during step III. The training will be conducted in the children's home by the parents on a daily basis under weekly supervision by the therapist responsible for each specific step of the intervention. General principles for the small step program are: a) collaborative goal-setting; b) promote infant's self-initiated actions; c) use of enriched home environment, d) intensity and repetition.

Before and after the intervention, there is a baseline phase with no treatment (A) and a withdrawal phase with no treatment (A), resulting in the following design: A-B-C-D-B-C-A. In addition, there is a follow-up phase when the children are 2 years of age.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 7, 2021
• Est. primary completion date: June 7, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 8 Months

Eligibility

Inclusion Criteria:

• increased perinatal risk factors, such as preterm birth, hypoxic ischemic encephalopathy (asphyxia), and morphological brain abnormalities. These "at-risk" children are included in the regular clinical follow-up program at St. Olavs University Hospital comprising a standard examination at 3 months of age (for preterm born children: 3 months post term, so-called corrected age). At this examination, infants who exhibit two or more of the following additional risk factors will be eligible for study participation:

• Neurological signs assessed with Hammersmith Infant Neurological Examination (HINE) with a cut-off score of < 57 (20).

• Delayed psycho-motor development measured with Alberta Infant Motor Scale (AIMS) using 2SD as the cut-off.

• Absent or sporadic fidgety movements assessed with the General Movements Assessment (GMA)

• Pathological findings on cerebral imaging (magnetic resonance imaging-MRI/cerebral ultrasound) done in regular clinical practice.

Exclusion Criteria:

• unstable medical condition

• progressive disorders

• diagnosis with a specific syndrome.

• neither parent is fluent in Norwegian or English. Satisfactory skills in either language are required for participation in data collection and the coaching and education program.

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Behavioral:
• Small Step Program
The Small Step intervention program has three alternating treatment foci (Hand use, Mobility, Communication) divided into five different steps, each lasting for 6 weeks (in total 30 weeks).

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (2)

Lead Sponsor	Collaborator
St. Olavs Hospital	Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Eliasson AC, Holmström L, Aarne P, Nakeva von Mentzer C, Weiland AL, Sjöstrand L, Forssberg H, Tedroff K, Löwing K. Efficacy of the small step program in a randomised controlled trial for infants below age 12 months with clinical signs of CP; a study protocol. BMC Pediatr. 2016 Nov 3;16(1):175. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hammersmith Infant Neurological Examination (HINE)	Identifies neurological signs in infants and is used to estimate the neurological development of infants aged two-24 months	at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
Other	The Working Model of the Child Interview (WMCI)	a semi-structured, open-ended interview designed to assess parent´s representations of their infant/ child and their relationship with their infant/ child. The WMCI will be used to measure change over time	at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
Other	The Ages & Stages Questionnaire: Social and Emotional (ASQ:SE)	a questionnaire to be completed by parents for assessing social and emotional difficulties in babies and young children	at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
Other	Norwegian Parenting Stress Index (PSI)	used to measure changes in perceived parental stress over time	at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
Other	The Hospital Anxiety and Depression Scale (HADS)	a self-assessment scale for parents and is used to detect changes in states of depression, anxiety and emotional distress over time among parents	at baseline, after the intervention at 30 weeks and at follow-up up at 2 years
Other	Pediatric Evaluation of the Disability Inventory (PEDI)	used to evaluate functional skills and caregiver assistance in the domains self-care, mobility, and social function over time. The child is assessed by structured interviews with the parents. The summary scores can be converted to normative standard scores and scaled scores, meaning that the child's performance will be compared with norms taken from typically developing children	at 2 years
Other	Bayley Scales of Infant Development (BSID-III)	a standard measurements to assess the motor (fine and gross), language (receptive and expressive), and cognitive development of infants and toddlers, ages 0-3. These scores will be used to determine the child's performance at two years of age compared with norms taken from typically developing children	at 2 years
Other	Norwegian Communicative Development Inventory (NCDI)	a parent questionnaire for assessing early language development of children. The NCDI involve questions about communication and language capacities corresponding to the child's ability to comprehend and use communication and language and will be collected	at 2 years
Other	Structural magnetic resonance imaging (MRI)/cerebral ultrasound	used to identify neuroanatomical abnormalities and underlying brain lesions. Neuroimaging data will be assessed by experienced neuroradiologists in accordance with well-established clinical assessment protocols at the hospital. This means that the children included in the project will not undergo any extra structural MRI examinations outside the normal clinical routine.	before 2 years corrected age
Other	General Movements Assessment (GMA)	identifies reduced movement quality (i.e. absent or sporadic fidgety movements) in infants at 3 months corrected age. The GMA is part of the clinical assessment performed at the hospital and is assessed by certified and experienced physiotherapists	at 3 months corrected age
Primary	Peabody Developmental Motor Scales, second edition (PDMS-2)	PDMS-2 is a standard measurement that assesses gross and fine motor skills in young children from birth through age 5 years. The PDMS-2 is composed of six subtests that assess related motor abilities that develop early in life. In this study, the Stationary, Locomotion, Grasping, and Visual-Motor Integration subtests will be used. The scores on these subtests are presented as percentiles, standard scores, and age equivalents.	up to 2 years
Secondary	Hand Assessment for Infants (HAI)	identifies and measures upper limb asymmetry and general manual development from 3-12 months	up to 2 years
Secondary	Alberta Infant Motor Scale (AIMS)	identifies infants with delayed or deviant motor development up to 18 months of age	up to 2 years
Secondary	Gross Motor Function Measure (GMFM-66)	an observational, standardized and criterion-referenced measure, developed to evaluate change in gross motor function in children with cerebral palsy (CP)	up to 2 years
Secondary	Parent-Child Early Relational Assessment (PC-ERA)	assesses parent-child interactions to capture the affective and behavioral characteristics that parent and child bring to the interaction, and the quality or tone of the relationship	up to 2 years
Secondary	Treatment Expectancy and Credibility Survey (TCS) - modification	assesses treatment expectations	up to 2 years