None listed
Conditions
Brief summary
Research suggests that 20 or more hours per week of intervention over several years may lead to significant improvements in long-term outcomes for young children with autism spectrum disorder (ASD). However, many families are unable to access or afford intensive early intervention. In these cases, it is possible that intervention for a few hours per week may be of some benefit. The early start Denver model (ESDM) is a promising intervention approach which has not been carefully tested when implemented at a low-intensity. This proposed study will examine the effectiveness of 2 hours a week of ESDM therapy delivered by a training and 1 hour a week or fortnight of parent coaching for 6 months. Families will be assigned at random to receive this treatment or to receive monthly support calls (“treatment-as-usual). The children will be aged between one and five years. We will measure each child’s engagement. Child outcome measures will include engagement, life skills, cognitive abilities, autistic traits, and language and communication. We will also measure parents’ use of therapy strategies, their stress levels, their sense of competence, and their quality of life. Intervention approaches that only require a few hours of professional input per week have the potential to significantly improve outcomes for individuals on the autism spectrum and their whanau.
Interventions
Low intensity Early Start Denver Model (ESDM) group
The low-intensity ESDM package will be delivered by a team of two trained therapists/ researchers and one parent coach/researcher. Each child will receive two 1-hour direct therapy sessions per week for the full 26 weeks. All therapy sessions will take place in the Autism NZ Resource Centre in Petone. Their parents will receive a 1-hour home-based coaching session per week for the first 13 weeks, and 1-hour per fortnight for the remaining 13 we
Low intensity Early Start Denver Model (ESDM) group The low-intensity ESDM package will be delivered by a team of two trained therapists/ researchers and one parent coach/researcher. Each child will receive two 1-hour direct therapy sessions per week for the full 26 weeks. All therapy sessions will take place in the Autism NZ Resource Centre in Petone. Their parents will receive a 1-hour home-based coaching session per week for the first 13 weeks, and 1-hour per fortnight for the remaining 13 weeks. The therapists will be trained to implement the therapy according to the principles of the ESDM, as detailed in the official ESDM intervention manual. Each of the two weekly sessions will involve play with highly preferred objects and ‘sensory social routines’ with the therapist. Parents may be present during the sessions but will be instructed to minimise interaction with their child. The therapist will implement the therapy using the following ESDM fidelity items: (a) management of attention; (b) behavioural teaching; (c) modulation of affect and arousal; (d) management of unwanted behaviours; (e) dyadic engagement; (f) optimisation of child motivation; (g) positive affect; (h) sensitivity and responsivity; (i) use of multiple and varied communicative functions; (j) appropriateness of language; (k) use of flexible joint activity routines; and (l) smooth transitions. The coach/researcher will implement each parent session according to the ESDM coaching manual. All information covered during the sessions will be based on the ESDM parent manual which will be given to each of the parents. One consistent parent will be required to participate in all of the coaching sessions. In the first 13 weeks, sessions will occur weekly and will last for one hour. The parent will select a strategy to learn every week, will practice this strategy with their child, and will reflect on this with the coach. In the following 13 weeks, when the parents have learned all the strategies, sessions will take place once a fortnight, and will focus on an area of the parents choosing or an area where parents have not yet reached fidelity. Sessions will involve the parent practicing all strategies with their child and reflecting on this with the coach. Therapist and coach fidelity will be assessed by a trained researcher during 5% of sessions. Parents will also complete a log of the amount of hours per week that they use the ESDM strategies.
Sponsors
Dr Hannah Waddington
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
1 Years to 5 Years
Healthy volunteers
Yes
Inclusion criteria
Children and families will be eligible for this trial if: (a) the child is between the ages of 1 and 5 years at the start of the study; (b) the child has an official diagnosis of ASD, or the child is highly likely to be diagnosed with ASD because they meet the criteria for ASD diagnosis based on a clinician-administered ADOS-2 assessment; (c) the primary caregiver involved in the trial speaks sufficient English to understand the requirements of the study and to be able to participate fully in the coaching sessions; (d) the child does not have another serious medical, genetic, neurological or sensory condition (e.g., Down syndrome, fragile X); (e) the child is not receiving 15 or more hours per week of professionally implemented early intervention; and (f) the family does not intend to move out of the Wellington region during the 6 month pre-and post-assessment period.
Exclusion criteria
None
Outcome results
None listed