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A Comparison of Approaches to Delivery of the Early Start Denver Model (ESDM) for the Reduction of Stress in Parents and the Acceleration of Developmental Progress in Preschoolers with Autism

Does Parent Coaching Early Start Denver Model (P-ESDM) Add Value to Other Evidence-Based Intervention for Preschoolers with Autism by Minimising Parent Stress?

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001282370
Acronym
VicASELCC P-ESDM
Enrollment
53
Registered
2017-09-06
Start date
2017-09-11
Completion date
2020-02-28
Last updated
2021-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Parents of children with autism experience greater parenting stress than those of typical children or children with other disabilities. While there is some evidence for efficacy of parent-mediated interventions, existing studies are limited in scope focusing on short-term child outcomes rather than potentially important longer-term outcomes for parents. This pragmatic RCT is achievable uniquely within the operations of the Victorian Autism Specific Early Learning and Care Centre (ASELCC), based in Melbourne Australia. We will determine whether a Parent Coaching approach to delivery of the Early Start Denver Model (P-ESDM) adds value to traditional therapist-delivered ESDM intervention, bringing benefits for parents and children with autism alike, over the short and medium term. Participants in this trial will be followed over 2 years. Initially, children will be recruited on the basis of enrolment (not at random) into one of three groups – ASELCC Playrooms and Autism Playmates (two different approaches to therapist-delivered ESDM), and community services Treatment as Usual controls. Following an eligibility assessment, enrolled participants will complete a baseline (BL) assessment including 1) standardised assessments with the child, 2) questionnaires and interviews completed by parents for self-reported mental health/wellbeing and parent-reported child functioning, 3) collection of naturalistic interaction samples for coding of parent and child behaviour, and 4) collection of parental saliva swabs for Cortisol Awakening Response and salivary Alpha Amylase Awakening Response assay. A mid-point assessment will be conducted 5 months later (5m MP) following which half of families will be randomly assigned to receive Parent Coaching or No Coaching (whilst continuing with their existing enrolment). An end-point assessment will occur 10 months post-BL (10m EP), following which all ASELCC-delivered ESDM-based therapy will cease (i.e., ASELCC Playrooms and Autism Playmates enrolment, and Parent Coaching), and families will transition to Treatment as Usual. A final follow-up assessment will occur 12 months later, 22 months post- BL (i.e., 22m FU). Analysis of the efficacy of Parent Coaching vs. No Coaching – as an adjunct to therapist-delivered intervention – will be conducted via intention to treat method on 10m EP data controlling for any 5m MP between-group differences. Planned preliminary analyses on baseline data will be conducted to 1) determine distribution of Clarke QRS scores in this sample to inform appropriate stratification on this measure, and 2) refine the coding framework for quantifying expressed emotion from five-minute speech samples. Further, to comply with reporting requirements of the funding body, planned interim analysis on BL and 5m MP data will be conducted to inform the short-term relative benefit of the two different therapist-delivered ESDM approaches (ASELCC Playrooms, Autism Playmates) vs. Treatment as Usual.

Interventions

Interventions are various approaches to delivery of Early Start Denver Model (ESDM; Rogers & Dawson, 2010), all implemented within the context of the Victorian Autism Specific Early Learning and Care Centre (ASELCC), in Melbourne, Australia. Intervention Phase A: Enrolment Groups with non-random assignment (occurring between Baseline [BL] and 10-month End-Point [10m EP] assessment) 1. ASELCC Playroom Children enrolled in ASELCC Playrooms will receive ESDM delivered in group- and centre-based

Interventions are various approaches to delivery of Early Start Denver Model (ESDM; Rogers & Dawson, 2010), all implemented within the context of the Victorian Autism Specific Early Learning and Care Centre (ASELCC), in Melbourne, Australia. Intervention Phase A: Enrolment Groups with non-random assignment (occurring between Baseline [BL] and 10-month End-Point [10m EP] assessment) 1. ASELCC Playroom Children enrolled in ASELCC Playrooms will receive ESDM delivered in group- and centre-based format, as developed and recently manualised by the Victorian ASELCC team (i.e., G-ESDM; Vivanti et al., 2017). The ASELCC Playrooms are situated within the La Trobe University Community Children’s Centre, a long day care program operating from 8.15am to 6.15pm. Within the ASELCC Playrooms, G-ESDM intervention hours are focused between 9.30am and 2.30pm with families encouraged to ensure their child attends during this period. Enrolment in ASELCC Playrooms is offered across one calendar year (approx. Feb-Dec) with most children attending 3 days per week (i.e., few children offered alternative placements to fill rooms to capacity). G-ESDM intervention delivery is by a core classroom staff of early childhood educators, with a maximum ratio of 1 adult to 4 children. At least one educator per room is ESDM Certified. All staff participate in annual ESDM training workshops and receive ongoing coaching and support from an on-site allied health team (psychologist/s, speech pathologist/s, occupational therapist/s) which include additional ESDM Certified Therapists. ESDM Trainers are also employed at the centre to oversee staff training needs and ongoing quality assurance of G-ESDM delivery. Each child undergoes an ESDM Curriculum Checklist assessment by an ESDM Certified Therapist at the start of their enrolment year, and quarterly thereafter. Intervention goals are written from this assessment and parent priorities, and these are targeted in the playroom across the rest of the quarter. Where child progress is behind what is expected, staff use an ESDM decision tree to determine changes that can be made to the teaching to better support the child's learning. ASELCC Playroom staff (who are not already ESDM Certified) receive initial/annual training followed by regular supervision and coaching across the calendar year by Senior ESDM Certified Therapists. Training will center around one-to-one ESDM implementation (across various children and activity contexts; Rogers & Dawson, 2010) and also G-ESDM practices (i.e., small-group and whole-of-classroom implementation; Vivanti et al., 2017). Formal fidelity checks will be conducted across the calendar year using the ESDM Fidelity Tool, with % fidelity computed. 2. Autism Playmates Children enrolled into Autism Playmates will receive ESDM delivered by Therapy Assistants in individual- and home/community-based format. This approach has been developed by the Victorian ASELCC team to provide an alternative and potentially more affordable option to the group/centre-based ASELCC Playroom model. Autism Playmates mirrors the one-to-one approach manualised by Rogers and Dawson (2010) but is adapted for delivery by trained paraprofessional staff (Therapy Assistants) under the supervision of an ESDM Certified Therapist and with consultation from the Victorian ASELCC allied health team. Autism Playmates is offered across approximately one year (i.e., 10-12 month period), comprising three or four cycles of A) assessment and goal planning, followed by B) 12 weeks of targeted delivery. Therapy Assistants (often undergraduate students of an allied health discipline) work directly with the child, for at least 10 hours per week, either in the family home and/or at the child’s local educational/care setting. Each child undergoes an ESDM Curriculum Checklist assessment by an ESDM Certified Therapist at the start of their enrolment year, and at the start of each quarterly cycle. An ESDM Trainer provides initial training to the Therapy Assistants, following which they begin to work with the child. The supervising ESDM Certified Therapist reviews and provides feedback to the Therapy Assistants on two videotaped submissions of their work with the child, soon after their initial training. Within each 12-week intervention delivery period, the supervising ESDM Certified Therapist meets three times with the Therapy Assistant/s and once with the child’s family to A) review delivery of ESDM and provide coaching as required, and B) review the child’s progress. Autism Playmates Therapy Assistants will receive initial training followed by regular supervision and coaching across the calendar year by Senior ESDM Certified Therapists. Training will center around one-to-one Training implementation with the specific child who the Therapy Assistant is working with, across various activity contexts. Following initial training, Therapy Assistants will submit video footage from two therapy sessions for a formal fidelity check by the supervising ESDM Certified Therapist. Over the course of the child’s program, the ESDM Certified Therapist will conduct further formal fidelity checks with each Therapy Assistant twice per 12-weekly therapy/goal cycle and provide coaching as required. These fidelity checks will be conducted via live observation against the ESDM Fidelity Tool with % fidelity computed. Intervention Phase B: Randomisation Group (occurring between 5-month Mid-Point [5m MP] and 10-month End-Point [10m EP] assessment) 1. Parent Coaching Half of families enrolled in this trial will be selected at random for Parent Coaching ESDM (P-ESDM). P-ESDM will be delivered by ESDM Certified Therapists who have completed subsequent training in P-ESDM Parent Coaching, and achieved fidelity prior to the commencement of work with trial families. Session content will follow Rogers, Dawson and Vismara (2012) and families will be provided with a copy of this book, on loan, for the duration of their P-ESDM intervention period. P-ESDM will comprise 13 x 1 hour clinic-based sessions, with the Parent Coach and participating parent and child in attendance. The series will comprise an initial goal planning session and 12 core sessions at weekly intervals. The initial P-ESDM session provides an opportunity for the Parent Coach to assess the child using the ESDM Curriculum Checklist and agree on child learning objectives with the parent. The parent and coach will also talk about the parent’s own goals for themselves. Subsequent sessions provide opportunities for the parent to receive hands-on practice with coaching in the implementation of the ESDM techniques and learning objectives with their child. The Parent Coach and parents will engage in discussion and reflection about the use of the techniques to support the child’s learning and engagement. Sessions are individualised to meet individual parents’ needs and learning styles and focus on supporting the transfer of techniques into everyday home routines. P-ESDM sessions will be conducted at a La Trobe University clinic space. The intention will be for the 15 P-ESDM sessions to be completed within the 5-month period following the child’s 5m MP assessment. Where delays to the planned scheduling occur (i.e., due to illness, public holidays, etc), therapists will attempt to complete as many as possible of the 13 sessions P-ESDM within the 5-month period (e.g., by reducing the time between booster sessions). However, any sessions outstanding beyond the 10m EP assessment will not be completed, with a shorter ‘dose’ of sessions noted. Parent Coaching staff will all be ESDM Certified Therapists who have subsequently participated in a training workshop on P-ESDM, completed coaching sessions with one or more practice families, and achieved fidelity prior to commencing work with trial families. P-ESDM staff will conduct monthly peer supervision sessions across the course of the trial. All Parent Coaching sessions with trial families will be video recorded for review during peer supervision, and to permit scrutiny of a proportion of tapes by independent raters against fidelity criteria using the ESDM Fidelity Tool with % fidelity computed.

Sponsors

La Trobe University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Other
Primary purpose
Treatment
Masking
Blinded (masking used) (Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
17 Months to No maximum
Healthy volunteers
No

Inclusion criteria

Children will be eligible if, at eligibility/baseline assessment, they: 1. Have an Autism Spectrum Disorder: a) Evidenced via a community clinical ASD diagnosis and exceeding ASD threshold on the Autism Diagnostic Observation Schedule – 2nd Edition (ADOS-2; Lord et al., 2012), Modules T, 1 or 2; or b) Exceeding ASD threshold on the ADOS-2 and meeting Clinical Best Estimate diagnosis of ASD according to DSM-5 by the Victorian ASELCC Senior Researcher. 2. Are aged between 17 and 43 months 3. Have non-verbal developmental age-equivalence equal to or greater than 12 months and are walking independently. We will seek to match the subgroups of 30 children enrolled (not at random) in the ASELCC Playrooms, Autism Playmates, and Community Services TAU groups, at eligibility/baseline assessment, on gender ratio and mean age, non-verbal developmental age-equivalence and severity of core autism symptoms. There are no additional inclusion criteria pertaining to parents/carers.

Exclusion criteria

1. Significant comorbid conditions in the child (e.g., hearing/visual impairment, physical disability such that the child is not yet walking); 2. Child twin status (concordant for Autism Spectrum Disorder). 3. Existing enrolment of a sibling of the child in this trial (i.e., only one child per family eligible); 4. Limited parental English competence (i.e., compromising full participation in Parent Coaching); 5. Significant unmanaged parental depression or anxiety (i.e., DASS subscale score in the severe/significant range without formal professional support); 6. Parental intention not to remain in Melbourne for the 2-year trial period.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026