Date

2023-06-01

Protocol

Protocol changed

Item Changed

Intervention(s) planned

Previous Version

Study Setting - Ayati, National Center for Children with Disabilities, Thalagolla Road, Ragama. Method of Randomization - stratified randomization - based on the age of recruitment list 1) 3-4 months list 2) 4.1-5 months list 3 ) 5.1-6 months. Eligible children stratified according to the age groups will be randomized to intervention and standard care packages. Unit of Randomization : intervention or standard care Method of sequence generation - The three lists will be allocated separately. Allocation will be done by a computer generated programme, random numbers will be issued by a person who is not involved in delivering the study interventions. Method of allocation concealment - Allocation concealment is done using the sealed envelope at the time of the recruitment. It will be opened by an independent administration officer attached to the Ayati center but who is not involved in delivering the intervention and will be directed to the relevant therapist for the specific intervention Carolina Curriculum or Standard Care. Intervention – Carolina Curriculum is an early intervention care package. Therapists will assess the child with the caregiver to identify the next targeted activity level combining two or more objectives into several specific activities with the materials which can be found within the home environment and that will be the intervention plan for each child. All the activities will be performed during weekly sessions with the therapist and all the instructions will be provided in writing with pictures and video recording to reinforce the demonstrations conducted during the training provided for each activity. Activities will be incorporated into their daily routines e.g. day care and home programs. Activities will be practiced everyday whenever possible. A timeline will be set for each activity and reassessment will be performed accordingly. After mastering the skill new skill level (to make it more challenging) and activity intervention will be selected. Parents will keep a record of the intervention they are doing at home in the form of a diary card. Standard care - The current standard care practice is a therapy program built on the principles of motor learning but delivered via demonstration and oral instructions only. Further there is no systematic program design; it is based on individual skill level of the child. Weekly appointments will be provided. (one face to face session followed by two tele-health sessions )Thirty minute sessions will be held at the physiotherapy area. The usual equipment and the toys in the physiotherapy room will be used for the session. Qualified Physiotherapist will assess the child and activities will be introduced according to the assessment findings. All the activities will be explained orally and demonstrated. The families are trained to deliver these interventions at home whenever possible within the daily routines; there is no strict prescription of therapeutic interventions. Blinding- Only the Assessor who does the assessments will be blinded.

Next Version

Study Setting - Ayati, National Center for Children with Disabilities, Thalagolla Road, Ragama. Method of Randomization - stratified randomization - based on the age of recruitment list 1) 3-4 months list 2) 4.1-5 months list 3 ) 5.1-6 months. Eligible children stratified according to the age groups will be randomized to intervention and standard care packages. Unit of Randomization : intervention or standard care Method of sequence generation - The three lists will be allocated separately. Allocation will be done by a computer generated programme, random numbers will be issued by a person who is not involved in delivering the study interventions. Method of allocation concealment - Allocation concealment is done using the sealed envelope at the time of the recruitment. It will be opened by an independent administration officer attached to the Ayati center but who is not involved in delivering the intervention and will be directed to the relevant therapist for the specific intervention Carolina Curriculum or Standard Care. CCITSN (Carolina Curriculum for Infants and Toddlers with Special Needs) CCITSN is based on the assessment-to-intervention approach. It is a developmentally tailored therapist and caregiver-led intervention strategy carried out in the infant’s natural environments. It allows locally and culturally appropriate toy selection. CCITSN is composed of an assessment log that includes self-explanatory items which will be the base for the selection of the intervention plan. Active child-directed motor learning strategies which minimize handling by a physiotherapist will be the focus of the therapy sessions. Each child will be assessed by the therapists in the presence of the caregiver to determine the present skill level to determine the next targeted activity level. The intervention plan will focus on two or more objectives and will include several specific activities using material found within the home environment. For the purpose of this study, the CCITSN was adopted to be delivered as a combination of face-to-face and telehealth sessions, once a week. In-person sessions and synchronous telehealth sessions will be conducted for one hour at the clinic. The asynchronous sessions will include a minimum of three short videos (5-10 minutes) of the child attempting the suggested activities and sent via social media (WhatsApp/ Viber / messenger and Imo) by the family. Feedback will be provided by the clinician within the same day to provide suggestions as appropriate. The ratio of person: telehealth sessions will be 1:2. Telehealth will be preferentially delivered through a synchronous method but the use of an asynchronous method will be an alternative option for situations where synchronous telehealth cannot be achieved. During asynchronous sessions, the videos will be reviewed and discussed using the chat feature. If required new activities or modifications to the current activities will be provided using example videos, images, or written documents. At all sessions, instructions will be provided in writing with diagrams and video recordings to demonstrate the activities for practice. It will be recommended that activities are incorporated into the child’s daily routines and practiced every day at home with caregivers whenever possible. A timeline is set for each activity and reassessments are carried out weekly during in-person and telehealth sessions. After mastering the criterion for each item outlined in the manual, a new more challenging skill level will be set and intervention activities selected. If the child is not responding or is slow to respond to a particular toy or a game suggested by the CCITSN manual a different toy or a different game will be offered as per manual processes. If the child is achieving the goal quickly, more challenging activities will be introduced. If feeding difficulties or other problems are identified, the infants will be referred to the appropriate service for further support and advice. Prior to in-person and synchronous sessions, the therapist will prepare toys and printed materials. Assessment of the child will be done at the beginning of the session. Time will be spent addressing any parental concerns regarding activities, making modifications to activities, or introducing new activities. A parent diary which will include a record of the activities and time spent on those activities between sessions will be checked and discussed. Staff Training protocol for CCITSN Each physiotherapist allocated to deliver the CCITSN intervention will attend specific training. This will include a one-week training course followed by practicing with 20 children before the commencement of the delivery of the intervention. The training session will include principles of the CCITSN, the assessment log, the progress chart, and intervention delivery. The therapist’s fidelity to the intervention delivery will be assessed by a fidelity checklist (annexure 1) administered by the PI. Standard care The therapists delivering standard care (SC) intervention will be a different group of qualified physiotherapists than those providing the CCITSN to prevent any contamination between groups. The current SC therapy program is built on child active interventions but delivered via demonstration and oral instructions only and activities will be therapist directed. Furthermore, there is no systematic program design; the intervention provided is based on the observed skill level of each child. SC in this study will continue for 6 months duration post-recruitment. Monthly 30-minute face-to-face sessions will be followed by two, weekly telehealth sessions at the clinic. Face-to-face sessions will be held within the physiotherapy clinic. The usual equipment and the toys in the physiotherapy room will be used for the session. The physiotherapists will observe the progress of the child and activities will be introduced according to the assessment findings. All the activities will be explained and demonstrated. Written instructions will be provided for parents as a reference. The families will be requested to practice these activities at home whenever possible within their daily routines. Activities will be tailored according to the child’s activity level. If feeding difficulties or other problems are identified they will be referred for the relevant expertise. Telehealth sessions will be conducted as synchronous and asynchronous methods depending on parent preferences. During the synchronous sessions, parents will be requested to perform activities and the therapist will review the activities and address any concerns or problems raised by caregivers. For asynchronous sessions, parents will be requested to send activity videos of the child via social media (WhatsApp/ messenger/ Viber /Imo) and comments will be given. If the parents do not have a smartphone, sessions will be conducted over the phone.