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Trial registered on ANZCTR

Registration number

ACTRN12617001282370

Ethics application status

Approved

Date submitted

29/08/2017

Date registered

6/09/2017

Date last updated

21/10/2021

Date data sharing statement initially provided

18/02/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1201-1442

Trial acronym

VicASELCC P-ESDM

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Autism

Stress

Condition category

Condition code

Mental Health

Autistic spectrum disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Treatment: Other

Intervention code [2]

Prevention

Intervention code [3]

Behaviour

Comparator / control treatment

Intervention Phase A: Enrolment Group with non-random assignment

3. Community Services TAU

A third (non-randomised) group of children will comprise any eligible child not receiving services via the Victorian ASELCC team (i.e., ASELCC Playroom or Autism Playmates enrolment). These children will be accessing any available local community service as ‘Treatment as Usual’, which may include allied health services, early intervention programs, etc. There will be no restriction on what types of community services participants in this group can receive, and we will systematically record information about the community services all participants are receiving by way of Community Services TAU so as to determine ‘dose’ and between-group comparability (i.e., frequency, duration, and type of intervention).

Intervention Phase B: Randomisation Group

2. No Coaching

The remaining half of families enrolled in this trial will not be provided with Parent Coaching by the Victorian ASELCC team. There will be no restriction on community services participants in this group can receive (including parent support, coaching, etc.) and we will systematically record information about the community services all participants are receiving.

Control group

Active

Outcomes

Primary outcome [1]

Parent: Parenting Stress score on Clarke modification of Questionnaire on Resources and Stress (Clarke QRS)

Timepoint [1]

Baseline, 5 month Mid-Point (of Intervention Phase A; start of Intervention Phase B), 10m End-Point (of Intervention Phase A; end of Intervention Phase B), and 22m Follow-Up (i.e., 1 year following cessation of both Intervention Phases A and B).

Primary outcome [2]

Parent: Expressed emotion within Five-Minute Speech Sample (5MSS) coded from parent narrative description of the child

Timepoint [2]

Secondary outcome [1]

Parent: Cortisol Awakening Response (CAR) and salivary Alpha Amylase Awakening Response (sAA-AR) collected across paired consecutive days via saliva swab and with assays run in duplicate using standard commercially available kits.

Timepoint [1]

Secondary outcome [2]

Parent: Mean depression, anxiety, and stress subscale scores on the Depression Anxiety Stress Scales (DASS)

Timepoint [2]

Secondary outcome [3]

Parent: Mean total score on Warwick Edinburgh Mental Wellbeing Schedule (WEMWBS)

Timepoint [3]

Secondary outcome [4]

Parent: % Fidelity against ESDM Fidelity Tool by parent within 10-minute filmed sample of Parent-Child interaction

Timepoint [4]

Secondary outcome [5]

Child: Mean domain total scores for child on ESDM Brief Curriculum Checklist

Timepoint [5]

Secondary outcome [6]

Child: Mean Auditory Comprehension and Expressive Language age-equivalence scores on Preschool Language Scales 5th Edition (PLS-5)

Timepoint [6]

Secondary outcome [7]

Child: Mean domain age-equivalence scores and Non-Verbal and Verbal developmental quotients on Mullen Scales of Early Learning (MSEL)

Timepoint [7]

Secondary outcome [8]

Child: Mean domain standard scores on Vineland Adaptive Behaviour Scales (VABS)

Timepoint [8]

Secondary outcome [9]

Child: Mean rates of intentional communication act (i.e., total of initiations and responses) toward parent within 10-minute filmed sample of Parent-Child interaction

Timepoint [9]

Eligibility

Key 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.

Minimum age

17 Months

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key 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.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Eligibility for the trial will occur prior to the baseline assessment. Intervention Phase A will be by non-random enrolment. Intervention Phase B will be by random assignment into Parent Coaching and No Coaching arms. This will occur following the 5m MP assessment. Randomization codes will be generated by an independent research administrator who is not part of the Victorian ASELCC clinical or research team.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation for Intervention Phase B will be by minimisation method, with stratification by A) Intervention Phase A enrolment group (i.e., ASELCC Playrooms, Autism Playmates, Community Services TAU) [weighted 2.0] B) child age at 5m MP assessment (i.e., less than vs. greater than or equal to 36 months) [weighted 1.0], and C) parent stress score on 5m MP Clarke QRS (i.e., less than vs. equal to or greater than 2.40 points) [weighted 1.0].

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people assessing the outcomes

Intervention assignment

Other

Other design features

The key evaluation for this trial concerns the efficacy of Parent Coaching vs. No Coaching, with random assignment across these two groups (in Intervention Phase B; occurring between 5m MP and 10m EP assessments). Prior to randomisation, participants will be enrolled, not at random, into one of three groups after BL assessment, and will continue within these groups through Intervention Phase A (i.e., from BL through 5m MP and to 10m EP assessment).

Preliminary/Interim analyses are pre-specified on BL and 5m MP data. Principal hypothesis testing on the efficacy of Parent Coaching will concern the 10m EP data. Target therapy offered from the Victorian ASELCC team will cease after 10m EP, with all families transitioning to Community Services TAU. We will also conduct a follow-up assessment one year after the cessation of Intervention Phases A and B (i.e., 22m FU).

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A sample size of n = 90 powers the trial well (>.95) to identify even small differences in parenting stress (Clarke QRS Total Score) as the primary outcome measure, between parents randomised to Parent Coaching vs. No Coaching groups. This is following the effect size of d=.31 observed in a similar sample by Estes et al. (2014).

Principal Hypothesis Testing:

Efficacy analysis of Parent Coaching ESDM (vs. No Coaching, and in addition to other types of intervention within Intervention Phase A) will by via ‘intention to treat’ method with analyses including all randomized participants. Significance level will be set at p < .05. Regression analyses will compare relative gains – from baseline through 5m MP to 10m EP assessment – among families randomly assigned to receive Parent Coaching vs. No Coaching. Stratified randomisation be on the basis of 5m MP assessment scores and 5m MP data will be examined via independent samples t-tests to determine the success of randomization for balancing out outcome measures across the Parent Coaching and No Coaching groups. Lack of statistical significance at a = .2 will imply successful randomization. Should this not be achieved, the principal analyses will be modified to adjust for baseline differences.

We will evaluate the following as potential moderators of outcome:
• Parent phenotypic traits and coping skills
• Child age, autism severity, and challenging behaviour

Preliminary/Interim Analyses:

We will monitor BL scores across participants enrolled (not at random) in Intervention Phase A groups – ASELCC Playrooms, Autism Playmates and Community Services TAU groups – on parent and child characterisation measures in attempt to ensure matching across these recruitment groups.

We will use mixed between-within subjects ANOVAs to examine change from BL to 5m MP assessments among these three (non-random) enrolment groups, anticipating:
• Main effects of visit (and potential group x visit interaction terms) on child outcome measures, given that children in all three groups will be receiving some form of intervention during this period.
• No such effects on parent outcome measures, given that no Parent Coaching will have yet occurred.

To comply with reporting requirements stipulated by the funding body, these analyses will be conducted:
1) In around June 2018: following the completion of 5m MP assessments for the first wave of participants in the ASELCC Playroom group (and including data from any participants who have completed 5m MP assessments in the Autism Playmates and Community Services TAU groups);
2) In around December 2018: following the completion of 5m MP assessments for further waves of participants in the Autism Playmates and Community Services TAU groups; and
3) In around June 2019: following the completion of all 5m MP assessments for participants in the trial.

Additional planned checks on BL data for our primary outcome measures have also been conducted during the initial months of the trial. Preliminary analysis of scores on the first 18 returned BL Clarke QRS have indicated a median score of 2.40 in the current cohort (vs. that of 2.0 reported by Estes et al., 2012). Hence, a cut-point of =2.40 is adopted for stratified randomisation. Preliminary analyses of pilot narrative descriptions of the child suggest that an appropriate coding framework for this trial and participant sample includes the number of positive and critical (i.e., negative) comments and the proportion of positive to critical comments, expressed during the five-minute speech sample (5MSS; Magana et al., 1986).

Preliminary analyses will exclude CAR and sAA-AR, as assays will only be run once all BL, 5m MP and 10m EP salivary swabs have been collected.

Results from these preliminary analyses will inform the short-term comparability of two different types of therapist-delivered ESDM approaches vs. Community Services TAU, and inform continued matching across our non-random assignment groups prior to randomisation to receive Parent Coaching vs. No Coaching (i.e., highlighting factors for statistical control within our main trial ITT analyses).

Recruitment

Recruitment status

Stopped early

Data analysis

Data collected is being analysed

Reason for early stopping/withdrawal

Lack of funding/staff/facilities
Participant recruitment difficulties

Date of first participant enrolment

Anticipated

11/09/2017

Actual

11/09/2017

Date of last participant enrolment

Anticipated

1/03/2020

Actual

28/02/2020

Date of last data collection

Anticipated

1/03/2022

Actual

11/01/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Department of Social Services

Address [1]

GPO Box 9820
Canberra ACT 2601

Country [1]

Australia

Primary sponsor type

University

Name

La Trobe University

Address

Kingsbury Drive, Bundoora VIC 3086

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

La Trobe University Human Ethics Committee

Ethics committee address [1]

Kingsbury Drive, Bundoora, VIC 3086

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

22/08/2017

Approval date [1]

29/08/2017

Ethics approval number [1]

HEC 16-136

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Kristelle Hudry

Address

La Trobe University
Kingsbury Drive, Bundoora
VIC 3086

Country

Australia

Phone

+61 3 9479 5649

Fax

+61 3 9479 1956

[email protected]

Contact person for public queries

Name

Kristelle Hudry

Address

La Trobe University
Kingsbury Drive, Bundoora
VIC 3086

Country

Australia

Phone

+61 3 9479 5649

Fax

+61 3 9479 1956

[email protected]

Contact person for scientific queries

Name

Kristelle Hudry

Address

La Trobe University
Kingsbury Drive, Bundoora
VIC 3086

Country

Australia

Phone

+61 3 9479 5649

Fax

+61 3 9479 1956

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All of the individual participant data collected during the trial, after de-identification

When will data be available (start and end dates)?

From publication of the primary trial outcome, and for at least 15 years thereafter

Available to whom?

The de-identified dataset will be placed with a La Trobe University data registry. A copy will be retained by the Chief Investigator who may provide access to other members of the research team and/or co-investigators of future projects subject to HREC approval.

Available for what types of analyses?

Any purpose

How or where can data be obtained?

Access subject to approvals by Principal Investigator and/or HREC

What supporting documents are/will be available?

Doc. No.	Type	Email
13703	Study protocol	[email protected]
13704	Informed consent form	[email protected]
13705	Ethical approval	[email protected]

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