Tele-rehabilitation Program: An Innovative and Sustainable Early Intervention Service for Children With Autism Spectrum Disorders

NCT05792449 | Unknown

• 1 other identifier: 2018/00753
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

In Singapore, Autism Spectrum Disorders (ASD) is ranked number one in disease burden for children 0-14 years of age. The Child Development Unit at the National University Hospital serves 3000 children annually, of which 25-30% of children have been diagnosed with ASD. Therapist roles are to provide interim therapy for these children before entry into community-based Early Intervention Centres (EIPIC), which currently have waiting times of 6-9 months. Current limitations with interim care includes long wait times, high cost for families, lack of manpower and space to serve the patients, poor parental involvement due to their work commitments, parental difficulties attending frequent, needed, in-hospital therapy and difficulty generalizing patient treatment to the home/community setting (decreasing effectiveness). The proposed Telerehabilitation (also called Telerehab) initiative involves the use of video conferencing technology to help address the aforementioned deficits. Offering early intervention through Telerehab will enable previously unattainable benefits such as seeing the child in their home environment, allowing multiple caregivers to have access to the early intervention training, more frequent contact with families and the ability to trouble shoot real life difficulties in real time. The important advantages to the caregivers include less financial burden arising from time off from work and travel, more access to treatment over a longer period of time and ability to access a multidisciplinary team. An additional benefit for the children is they need not travel to unfamiliar environments, which is frequently distressing for children with ASD. Lastly, Telerehab is a sustainable initiative allowing for less manpower to cover the growing number of patients, and the possibility to be implemented in other government run hospitals and clinics facing similar challenges. Elaboration of benefits:1) Importance of parent and caregiver empowerment. Early Intervention in the current model has been predominantly centre based with initiatives to increase caregiver education. A large body of literature suggests that early intervention is highly successful when provided at the age of diagnosis, with younger children yielding better outcomes. Caregiver involvement is vital to long-term success, as they spend a significant amount of time with their child; they can support the generalizations of new skills. National Research Council identifies parent training to be the key component for successful intervention for children with autism. Parent training improves quality of life by reducing parental stress and increasing optimism.2) Addressing nationally identified gaps. The Enabling Master plan recommendations for 2012-2016 (under Ministry of Family and Social Development) identifies gaps in family involvement and support in acquiring necessary skills and knowledge to be competent in helping their children make developmental gains. Child Development Unit (CDU) envisions that Telerehab is a viable avenue for supporting parents in learning EI skills.3) Improving existing parent training programmes. CDU has successfully piloted a parent-training program for children with ASD called SPEECCH. In our study of the impact of this parent-training program, children made measurable progress in all four skill areas assessed (p\<0.001). Focus on achievable and observable family- centred developmental goals showed evidence for increased parental understanding of children's learning and behaviour amp; effective use of strategies for facilitating communication and interactions to support their child's development (p\<0.001). However this intervention service could not be sustained due to high caseload demands and insufficient manpower. Parent interviews during review visits identified having sustained contact with therapists and parent coaching to be key areas of need. Currently the service provides intervention for 24 children with ASD weekly for one hour across 12 weeks, and continued support for up to 20 weeks (maximum of 16 hours of intervention). Of the new referrals of 150 children with ASD, if a sustained service is to be provided, only a small group of children will receive intervention. In order to address the demand, the frequency and intensity of intervention has had to be sacrificed to be able to provide some service to all patients. Hence to maximize the impact of early intervention, a sustainable model of service delivery using technology through videoconferencing is being proposed.

Conditions

Autism Spectrum Disorder

Keywords

Parent coaching; Parent-implemented intervention; Telerehabilitation; Randomised controlled trial; Non-inferiority

Outcome Measures

Primary Outcomes (1)

• Mullen's Scale of Early Learning (MSEL)

  MSEL is a standardized developmental assessment to examine developmental skills using 5 subscales: Gross Motor, Visual Reception, Fine Motor, Expressive Language and Receptive Language. For each scale, the assessment derives a T-score with a mean of 50 and standard deviation of 10, a percentile score, and an age equivalent. An early learning composite (ELC) score is calculated from the total of the subscale scores (except the gross motor scale) with a mean of 100 and standard deviation of 15 (Bacon et al., 2014). The use of MSEL subscale scores allow for greater granularity of analysis, to examine the impact of intervention on specific functions of the child and for separate assessment of verbal and non-verbal abilities (Vismara et al, 2009). Differences in the T-scores on the subscales of the MSEL as well as MSEL ELC from baseline to program conclusion will be calculated and compared between the two intervention groups. The margin of non-inferiority is set at 5 units.

  Change from baseline MSEL assessment at study completion, an average of 1 year

Secondary Outcomes (7)

• Vineland Adaptive Behaviour Scales (VABS-III)

  Change from baseline VABS-III assessment at study completion, an average of 1 year

• Joint Engagement Rating Inventory (JERI)

  Change from baseline parent-child interaction based on JERI at study completion, an average of 1 year

• Parenting Stress Index-Short Form (PSI-SF)

  Change from baseline PSI-SF assessment at study completion, an average of 1 year

• Families in Early Intervention Quality of Life (FEIQoL)

  Change from baseline FEIQoL assessment at study completion, an average of 1 year

• Cost survey

  Change from baseline cost assessment at study completion, an average of 1 year

Study Arms (2)

Standard Program

ACTIVE COMPARATOR

The current standard program for early intervention treatment is in-clinic therapy based on the Foundational Skills Curriculum (FSC): a framework for early intervention developed from outcomes of an Autism research project conducted in the UK. This framework provides a clear and systematic approach to understanding the child's functioning in 3 core areas of development (across 141 items): Play, Social Interaction, and Communication. Children and their parents will receive the standard program which consists of 16 clinic-based intervention sessions of 60 minutes each, separated into 3 intervention blocks, with breaks in between so that parents will have opportunities to practise at home.

Behavioral: Foundational Skills Curriculum

Telerehab Program

EXPERIMENTAL

The telerehab program will provide parent coaching through video conferencing using the FSC. The telerehabilitation program commences with 2 clinic-based intervention sessions of 60 minutes each followed by 16 video conferencing-based sessions of 45 minutes each. For clinic-based sessions, an additional 15 minutes is allocated to allow parent-child dyads to transit into and out of the therapist's room.

Behavioral: Foundational Skills Curriculum - Telerehabilitation

Interventions

Foundational Skills Curriculum BEHAVIORAL

The therapist will coach parents in the context of clinic-based play activities and help parents identify contexts and activities at home where the parents could follow up on the program at home. Intervention sessions empower and equip parents with skills and strategies to engage with their child at home. Since the program involves behavioural intervention and parent coaching, active participation of parent and child are key to each session.

Also known as: Naturalistic, parent-implemented intervention

Standard Program

Foundational Skills Curriculum - Telerehabilitation BEHAVIORAL

Parent-child interactions during activities at home will be observed through video conferencing. Parents will be encouraged to interact with their child using strategies aimed at increasing their child's attention and motivation, turn-taking routines, initiating and responding to joint attention, communication, etc. Intervention sessions empower and equip parents with skills and strategies to engage with their child at home. Since the program involves behavioural intervention and parent coaching, active participation of parent and child are key to each session.

Also known as: Naturalistic, parent-implemented intervention delivered through vide conferencing

Telerehab Program

Eligibility Criteria

• Age: 15 Months - 48 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 15-48 months
• Children meet cut off score for Autism Spectrum Disorders (ASD) on Autism Diagnostic Observation Schedule-2 (ADOS): The Autism Diagnostic Observation Schedule (ADOS) is a semi-structured assessment of communication, social interaction, and play (or imaginative use of materials) for individuals suspected of having autism or other pervasive developmental disorders. The ADOS consists of a toddler module and four other modules, each of which is appropriate for children and adults of differing developmental and language levels, ranging from nonverbal to verbally-fluent. The ADOS consists of standardized activities that allow the examiner to observe the occurrence or non-occurrence of behaviours that have been identified as important to the diagnosis of autism and other pervasive developmental disorders across developmental levels and chronological ages.
• Parent(s) is/are willing and able to give informed consent
• Families with at least one parent who is digitally literate with the home use of the internet and access to Wi-Fi
• The same parent(s) or caregiver(s) in attendance for most intervention sessions and all review sessions in order to monitor performance across outcome measures

You may not qualify if:

• Participants not having access to the internet will be excluded
• Children with genetic and other associated auditory or visual impairment and/or seizure disorders

Sponsors & Collaborators

• National University Hospital, Singapore: lead
• Ministry of Health, Singapore: collaborator
• National University of Singapore, Saw Swee Hock School of Public Health: collaborator

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

Location

Related Publications (4)

• Loyd BH, Abidin RR. Revision of the Parenting Stress Index. J Pediatr Psychol. 1985 Jun;10(2):169-77. doi: 10.1093/jpepsy/10.2.169. No abstract available.

  PMID: 4020601 BACKGROUND

• Bacon EC, Dufek S, Schreibman L, Stahmer AC, Pierce K, Courchesne E. Measuring outcome in an early intervention program for toddlers with autism spectrum disorder: use of a curriculum-based assessment. Autism Res Treat. 2014;2014:964704. doi: 10.1155/2014/964704. Epub 2014 Mar 10.

  PMID: 24711926 BACKGROUND

• Vismara LA, McCormick C, Young GS, Nadhan A, Monlux K. Preliminary findings of a telehealth approach to parent training in autism. J Autism Dev Disord. 2013 Dec;43(12):2953-69. doi: 10.1007/s10803-013-1841-8.

  PMID: 23677382 BACKGROUND

• Sia IKM, Kang YQ, Lai PL, Mahesh M, Chong SC. Parent coaching via telerehabilitation for young children with autism spectrum disorder (ASD): study protocol for a randomised controlled trial. Trials. 2023 Jul 19;24(1):462. doi: 10.1186/s13063-023-07488-6.

  PMID: 37468898 DERIVED

MeSH Terms

Conditions

Autism Spectrum Disorder

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Computer-generated randomisation will be used to randomly assign the participants to one of the intervention groups. Block randomisation will be used to allocate the recruited subjects into one of the interventions. A randomisation list will be generated by the study statistician and envelopes will be prepared. Although the allocation of intervention will be concealed and the study team will not know in advance which subject will receive which intervention, the blinding will not be possible once the intervention is assigned. Assessors of the initial and final MSEL were not told of the intervention status of the patient to avoid bias in outcome assessment. Blinding of the parents is not possible in the context of this study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants willing to participate in the proposed research study and providing informed consent will be randomized to either the experimental (telerehab program) or control (standard program) arm of the intervention.

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 31, 2023
• Study Start: January 7, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: March 31, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)