Autism Spectrum Disorder Clinical Trial
Official title:
Tele-rehabilitation Program: An Innovative and Sustainable Early Intervention Service for Children With Autism Spectrum Disorders
Verified date | March 2023 |
Source | National University Hospital, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 200 |
Est. completion date | May 31, 2023 |
Est. primary completion date | May 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 15 Months to 48 Months |
Eligibility | Inclusion Criteria: 1. Children aged 15-48 months 2. 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. 3. Parent(s) is/are willing and able to give informed consent 4. Families with at least one parent who is digitally literate with the home use of the internet and access to Wi-Fi 5. 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 Exclusion Criteria: 1. Participants not having access to the internet will be excluded 2. Received or receiving other treatment or interventions (Note: this is an exclusion criterion but not a withdrawal criterion) 3. Children with genetic and other associated auditory or visual impairment and/or seizure disorders |
Country | Name | City | State |
---|---|---|---|
Singapore | National University Hospital, Singapore | Singapore |
Lead Sponsor | Collaborator |
---|---|
National University Hospital, Singapore | Ministry of Health, Singapore, National University of Singapore, Saw Swee Hock School of Public Health |
Singapore,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Vineland Adaptive Behaviour Scales (VABS-III) | VABS-III is a standardised assessment tool that utilises a semi-structured interview format to measure adaptive behaviour. The main domains are: Communication, Daily Living Skills and Socialization. VABS-III provides a measure of adaptive skills used to cope with challenges of daily living. A caregiver completes a questionnaire regarding the individual's current level of functioning across three domains: communication, daily living skills and socialization. The Vineland Scales are applicable to children with and without delays from birth to 18 years, 11 months. All scales use standard scores with a mean of 100 and a standard deviation of 15, a percentile score, and an age equivalent indicating at what developmental age the individual is performing. Scores on the three domains are combined to obtain an overall adaptive behavior composite (ABC) with a mean of 100 and a standard deviation of 15. | Change from baseline VABS-III assessment at study completion, an average of 1 year | |
Secondary | Joint Engagement Rating Inventory (JERI) | JERI measures joint engagement, communication dynamics and shared topics during parent-child interactions (Adamson & Bakeman, 2012). Raters will view video recordings of parent-child interaction and assess the interaction on a 7-point Likert scale. While the original inventory consists of a total of 27 items, JERI has been adapted as an 8-item scale in this study that cuts across the 4 domains of joint engagement, child's participation in joint engagement, caregiver behaviour during engagement and the quality of the caregiver-child interactions. Since joint engagement is a precursor for subsequent social interaction and language development, it serves as an important component of early intervention. The change scores from baseline to midterm to program conclusion will be compared between the two intervention groups to see if telerehabilitation is as effective as standard care in enhancing parent-child interaction. | Change from baseline parent-child interaction based on JERI at study completion, an average of 1 year | |
Secondary | Parenting Stress Index-Short Form (PSI-SF) | PSI-SF (Loyd & Abidin, 1985) is an abbreviated version of the PSI. It is a 36-item self-report questionnaire assessing the level of relative stress in a parent-child relationship. Each item requires the parent/caregiver to rate the degree to which s/he agrees with a statement on a five-point Likert scale (1 = Strongly Agree, 2 = Agree, 3 = Not Sure, 4 = Disagree, and 5 = Strongly Disagree). The questionnaire is divided into three subscales: Parental Distress (PD), Parent-Child Dysfunctional Interaction (P-CDI), and Difficult Child (DC). The PSI-SF produces subscale raw scores ranging from 12 to 60 and an overall Total Stress score that ranges from 36 to 180. A higher score indicates a greater level of stress. Although this parent coaching program does not aim to directly decrease parental stress, equipping parents with strategies to manage and support their child's behaviour will increase their self-efficacy and could result in lower parental stress. | Change from baseline PSI-SF assessment at study completion, an average of 1 year | |
Secondary | Families in Early Intervention Quality of Life (FEIQoL) | FEIQoL includes 40 items across 4 domains rated on a 5-point Likert scale - (a) Family Relationships (Problem solving, communication, parenting, relationships with extended family, and family participation in social activities); (b) Access to Information and Services (Knowledge of their child's disability, child development, managing challenging behaviors and resources such as support services, medical assistance, and organizations in their community); (c) Child Functioning (Child's engagement, independence, and social relationships within family daily routines) and (d) Overall Life Situation (Fulfillment of family needs in health, financial resources, and employment). | Change from baseline FEIQoL assessment at study completion, an average of 1 year | |
Secondary | Cost survey | The cost survey will measure non-healthcare direct and indirect costs as a result of attending intervention sessions, including transportation costs, additional assistance costs and productivity losses. | Change from baseline cost assessment at study completion, an average of 1 year | |
Secondary | Parent Satisfaction Survey | This 13-item survey uses a 5-point Likert scale to obtain parents' feedback at the end of the program. Each item requires the parent/caregiver to rate the degree to which s/he agrees with a statement on a five-point Likert scale. | At study completion, an average of 1 year | |
Secondary | NDBI-Fi | NDBI-Fi is an 8-item observational rating scheme that evaluates caregiver implementation of specific strategies that have been identified to be common among naturalistic developmental behavioural intervention programs. The rating scheme uses a 5-point Likert scale to evaluate parents' implementation of strategies based on short videos of caregiver-child interactions during free play. Since the intervention model involves parent coaching where parents play a key role in actively learning and implementing intervention strategies, parents should demonstrate high fidelity to facilitate their child's improvement. | Change from baseline parent intervention fidelity based on NDBI-Fi at study completion, an average of 1 year |
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