The Small Step Program - Early Intervention for Children With High Risk of Developing Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): Small Step Program
Intervention type(s): Behavioral
Intervention description(s): 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).
Intervention model: Single Group Assignment
Intervention model description: Single-subject research design (SSRD) will be used with each participant serving as his/her own control.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Infant; Hand/Growth & Development; Motor activity; Exercise; Communication