Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616000819426
Ethics application status
Approved
Date submitted
9/06/2016
Date registered
22/06/2016
Date last updated
22/10/2021
Date data sharing statement initially provided
9/07/2019
Date results information initially provided
9/07/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
A parent-delivered intervention for infants with social and communication delay
Scientific title
Investigating the efficacy of a parent-mediated behavioural intervention for mitigating autistic symptom severity among infants with social and communication delay
Secondary ID [1] 289409 0
None
Universal Trial Number (UTN)
U1111-1184-0848
Trial acronym
The Australian Infant Communication and Engagement Study (AICES)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 299076 0
Developmental Language Disorder 299077 0
Condition category
Condition code
Mental Health 299110 299110 0 0
Autistic spectrum disorders
Mental Health 299123 299123 0 0
Learning disabilities
Physical Medicine / Rehabilitation 299124 299124 0 0
Speech therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention, called iBASIS-VIPP (Green et al.,, 2013; 2015), focuses on enriching social and communication exchanges between an infant and their caregiver. The manualised intervention will be delivered in family homes by a Research Therapist (Speech Pathologist/Psychologist). One parent will be asked to participate in all of the therapy sessions. They will receive 10 X 1.5-2 hours sessions over five months. During therapy sessions, parent and infant are videotaped during daily interactions. Video feedback provides the opportunity to focus the caregiver’s attention on the infant’s communicative signals and expressions, thereby stimulating skills for observing and empathising with the child. Core methods include:(1) a focus on the communicative aspects of the particular parent-infant dyad; (2) viewing ‘successful’ excerpts from videotaped interactions, providing positive examples of sensitive parenting; and (3) involvement of a trained therapist to frame observations to assist self-reflection, and to focus behavioural change. Intervention content focusses on enhancing parental observation, attributing communicative intent to infant behaviours that may be difficult to interpret, and facilitating responses that will build infant interaction. To this foundation, we have added components that have been tested in our previous ASD intervention studies, focusing on promoting early social communication skills, such as joint attention and turn-taking. Parents will also be asked to undertake 30-mins daily home practice in interacting with their infant using the newly learned skills, and document the quantity of home practice they undertake. As with the Treatment as Usual group, we will also quantify and qualify any contact the families have with other health professionals.

References:
Green J, Wan M, Guiraud J, Holsgrove S, McNally J, Slonims V, et al. Intervention for infants at risk of developing autism. J Autism Dev Disord. 2013;43(11):2502-14.
Green J, Charman T, Pickles A, Wan MW, Slonims V, et al. Parent-mediated intervention versus no intervention for infants at high risk of autism. Lancet Psychiatr. 2(2):133-40.
Intervention code [1] 294992 0
Behaviour
Comparator / control treatment
Families in the "treatment as usual" group will receive current treatment protocol offered within the community, which may comprise a 'parent information workshop', the provision of reading material on infant development, or developmental monitoring. Within the "treatment as usual" group, we will quantify all contact with health professionals by asking parents to complete a monthly diary. We will also quantify the nature of this contact by directly contacting the health professional(s) involved.
Control group
Active

Outcomes
Primary outcome [1] 298583 0
The primary outcome for the First Phase Analysis is the Autism Observation Scale for Infants (AOSI). The AOSI is a measure of the severity of autistic symptoms at Follow-up Assessment 1. The AOSI is a semi-structured observational assessment used to assess the early behavioural expression of ASD. The AOSI examines precursors of later autism symptoms such as response to name, social reciprocity and imitation, as well as items assessing motor and sensory skills. Behaviours are coded 0, 1, 2 and 3 with a higher score indicating a greater level of autistic-like atypicality. The total score is calculated by summing all items in the battery, excluding items 19, 20 and 21, which generates a range of scores from 0 to 38.
Timepoint [1] 298583 0
Baseline assessment will occur within 2 weeks of ascertaining study eligibility.

The primary outcome will be assessed at:
Follow-up assessment 1 (6 months post-baseline assessment)
Primary outcome [2] 307023 0
The Autism Diagnostic Observation Schedule – Second Edition (ADOS-2) will be used (along with the AOSI) to measure the severity of autistic symptoms in the Second Phase Analysis. The ADOS-2 is a semi-structured assessment developed to elicit behaviours relevant to an ASD diagnosis in toddlers aged 12-30 months (Toddler Module) or 31 months and above (Module 1 [non-verbal/single-word speech] and Module 2 [phrase speech]). Total ADOS-2 Algorithm scores will be used, and these range from 0 to 28.
Timepoint [2] 307023 0
The ADOS-2 will be administered at Follow-up Assessment 2 and 3
Secondary outcome [1] 324634 0
Parent-infant free-play interaction was filmed at each visit. Parents were asked to play with their child as they would usually at home with toys (provided by the study team) if they so wished. Six minute clips were later coded using the Manchester Assessment of Caregiver-Infant interaction (MACI) by a trained coder, blind to family information. The measure comprises 2 caregiver scales (sensitive responsiveness, non-directiveness), 4 infant scales (attentiveness to caregiver, positive affect, negative affect, liveliness), and 2 dyadic items (synchrony/mutuality, quality of engagement). Each item involves rating on a 7-point scale (ranging from 1-7). Videos recorded at Baseline and Follow-up Assessment 1 will be coded according to the ‘Infant’ version of the MACI, and videos recorded at Follow-up 2 and 3 will be coded according to the ‘Toddler’ version of the MACI.
Timepoint [1] 324634 0
Baseline assessment will occur within 2 weeks of ascertaining study eligibility. This secondary outcome will be assessed at: Follow-up Assessment 1 (6 months post-Baseline Assessment) Follow-up Assessment 2 (12 months post-Baseline Assessment) Follow-up Assessment 3 (24 months post-Baseline Assessment)
Secondary outcome [2] 324635 0
The Mullen Scales of Early Learning (MSEL) is a standardised developmental assessment, which examines early motor and cognitive development from 0-68 months. The assessment is comprised of five subscales Gross Motor, Visual Reception, Fine Motor, Receptive Language and Expressive Language. Analyses will use subscale T-scores (ranging plausibly from 20-80) unless the data description phase gives evidence of floor-effects, in which case raw scores (ranging plausibly from 0-50) may be used, together with covariation for age at assessment.
Timepoint [2] 324635 0
Baseline assessment will occur within 2 weeks of ascertaining study eligibility. This secondary outcome will be assessed at: Follow-up Assessment 1 (6 months post-Baseline Assessment) Follow-up Assessment 2 (12 months post-Baseline Assessment) Follow-up Assessment 3 (24 months post-Baseline Assessment)
Secondary outcome [3] 324636 0
The Vineland Adaptive Behavior Scales – 2nd edition (VABS-2) is a parent report measure of daily living skills, which yields scores across a range of ages and competency levels for a range of domains (e.g. motor, communication, personal independence, socialisation). Items are scored on a three-point scale: Never ‘0’, Sometimes ‘1’ or Usually ‘2’, with Don’t Know or No Opportunity responses also possible (and rescored as ‘1’, provided there are not more than two such responses within a given subscale; in which case the subscale score is treated as ‘invalid/missing’). Analysis will use standard scores for the Communication and Socialization domains (each ranging plausibly from 20-140), unless the data description phase gives evidence of floor effects, in which case raw scores (ranging plausibly from 0-198) may be used together with covariation for age at assessment.
Timepoint [3] 324636 0
Follow-up Assessment 1 (6 months post-Baseline Assessment) Follow-up Assessment 2 (12 months post-Baseline Assessment) Follow-up Assessment 3 (24 months post-Baseline Assessment)
Secondary outcome [4] 324637 0
The MacArthur-Bates Communicative Development Inventory (MCDI) is a standardised parent report measure of vocabulary knowledge and other early communication skills appropriate for typical infants aged 8-30 months, but relevant also for older children with language abilities at this level. Two forms exist – Words and Gestures (MCDI-WG) typically for infants aged 8-18 months, and Words and Sentences (MCDI-WS) typically for infants aged 16-30 months. In either form, parents endorse the number of words the child understands, or both understands and says among an inventory spanning different semantic categories (i.e., action words, people etc.) for a plausible total of 396 (WG form) or 680 words (MCDI-WS form). Other subsections of the MCDI pertain to child communicative and symbolic gesture use (i.e., subsections with responses ‘not yet’ [coded 0], and ‘sometimes’ or ‘often’ [both coded 1]) or ‘yes’/’no’ responses [also coded ‘0’ and ‘1’]. We will compute an Expressive Vocabulary Count as the total of all ‘understands and says’ items endorsed, and a Receptive Vocabulary Count as the combined total of all ‘understands’ and ‘understands and says’ items endorsed on the relevant form (WG/WS) at each visit. We will also compute a Total Gestures score as the sum of endorsed items (i.e., coded ‘1’).
Timepoint [4] 324637 0
The MCDI-WG form is provided at Baseline as well as Follow-up Assessment 1 and the MCDI-WS form (with MCDI-WG Gestures supplement) provided at Follow-up Assessments 2 and 3.
Secondary outcome [5] 350411 0
The Parenting Sense of Competence (PSOC) scale is a parent-report questionnaire that asks respondents about their own sense of parenting efficacy. Each item involves rating on a 6-point scale (ranging from 1-6). Endorsed PSOC items are summed to yield three subscales: Satisfaction (scores ranging plausibly from 6-36), Efficacy (scores ranging plausibly from 5-30) and Interest (scores ranging plausibly from 3-18). After reverse coding a number items, higher scores indicate greater parent satisfaction, efficacy and interest.
Timepoint [5] 350411 0
Baseline and Follow-up Assessments 1, 2 and 3.
Secondary outcome [6] 402179 0
A further outcome of interest is a determination of the ASD diagnostic status of the infants at the final assessment - a so called 'Best Estimate Clinical Judgment' of diagnostic status. This determination will be made following assessment at 24 months’ post baseline, when we anticipate a mean age of approximately 3 years, and will draw on available data for children collected at their 12- and 24-month post baseline assessments. The clinical team making the judgment will be asked to generate a best estimate clinical judgment, according to four options: (1) Definite ASD; (2) Possible ASD; (3) no developmental concerns; (4) other developmental concern (with a description of these). A separate protocol document describes the process for determine the best estimate clinical judgement. This has been uploaded to Open Science Framework: https://osf.io/qt9gy/quickfiles .

Following a previously described approach (Green et al., 2017), these three categories will be analysed as three groups: clinical ASD (define ASD), atypical development (possible ASD and other developmental concerns),, and typical development (no developmental concerns).


Green J, Pickles A, Pasco G, Bedford R, Wan MW, Elsabbagh M, et al. Randomised trial of a parent-mediated intervention for infants at high risk for autism: longitudinal outcomes to age 3 years. Journal of Child Psychology and Psychiatry. 2017;58(12):1330-40.
Timepoint [6] 402179 0
Follow-up Assessment 3 (24 months post-Baseline assessment).

Eligibility
Key inclusion criteria
Infants will be offered participation in this trial if they:
(a) Are between 9 and 14 months of age;
(b) Endorsement of three or more of the ‘key items’ on the 12-month old SACS-R screening questionnaire (Barbaro & Dissanayake, 2010): absent/atypical pointing, waving, imitation, eye contact, response to name.
(c) The primary caregiver involved in the trial speaks sufficient English to: (i) understand the requirements of the study, and (ii) is deemed to be able to participate fully in the therapy sessions.

Reference:
Barbaro J, Dissanayake C. Prospective identification of ASD in infancy and toddlerhood using developmental surveillance. J Dev Behav Pediatr. 2010;31(5):376-85
Minimum age
9 Months
Maximum age
14 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded from the study if they meet either of the following characteristics:
(a) The infant has a diagnosed comorbidity known to affect neurological and developmental abilities (e.g., preterm birth < 32 weeks, cerebral palsy, Down syndrome, Rett syndrome, other chromosomal abnormality, hearing/visual impairment), and/or
(b) The family does not intend to remain living in the Perth/Melbourne areas for the next two years.

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)
Allocation involves contacting the holder of the allocation schedule who is at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Group allocation of participants will be by minimization method, stratified (with blocking) by:

Childs age (based on age at the eligibility screen):
1.. 9 to 11 months inclusive (covers 9.00 months to 11.99 months)
2.. 12-14 months inclusive (covers 12.00 to 14.99 months)

Sex:
1.. Male
2.. Female

SACS-R severity score:
1. Score total 3
2. Score total 4
3. Score total 5

Site:
1. Perth
2. Melbourne
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The analysis will be separated into two phases across the three follow-up assessments:
(1) First Phase Analysis of immediate post-treatment outcomes (data from Follow-up Assessment 1), and
(2) Second Phase Analysis of medium-term outcomes (combining outcome data across Follow-up Assessments 1, 2 and 3).

Treatment Blinding: The analysis plan has been written prior to linkage of the treatment allocation variable to outcome data (i.e., completion of the final Follow-up Assessment 1 session), and prior to treatment unblinding. All analyses will be undertaken by a biostatistician blind to the treatment group coding.

Data description: The patterns of availability of baseline and follow-up data will be summarised separately for the two treatment groups for each measure. Descriptive summary statistics of means and standard deviations, means and interquartile ranges, and proportions will be presented as appropriate. No statistical significance tests or confidence intervals will be calculated for the difference between randomised groups on any participant-level baseline variables. The randomisation of participants to intervention groups should have ensured that any imbalance over all measured and unmeasured baseline characteristics is due to chance.

Missing data: The pattern of missing data, and the reasons for it, will be described. Analyses of data involving missing outcome measures will be undertaken wherever possible by full information maximum likelihood (ML). The primary approach to handling missing baseline data will be using multiple imputation (MI), carried out using iterative chained equation approach as implemented in R. Both ML and MI allow for potentially selective attrition. Where – for any analysis – complete data cases falls below 70%, complete-case only analyses will also be reported. Where MI is used, complete case analysis will also be carried out and presented for comparison.

Treatment Compliance: The mean and range of the proportion of iBASIS-VIPP treatment sessions attended will be reported. The criterion set for minimum compliance is attendance at and completion of 4 sessions.

Effect Estimators: Analysis of the intervention effect element of the study will initially use an intention to treat (ITT) principle, in which participants will be analysed in the groups to which they were randomised utilising all available follow-up data from all randomised participants. Analysis will compare endpoint group effects using a priori hypotheses related to each measurement domain. Where the treatment compliance does not reach the pre-specified ‘minimum’, the Local Average Treatment Effect (LATE) will also be reported for the primary outcome. The LATE approach continues to exploit the randomized to treatment allocation undertaken, and is also valuable in obtaining estimates of mediation unbiased by residual confounding.

Control Variables: Analyses will control for minimisation stratification variables (where ‘age group’ may be replaced with ‘exact age at testing’), variables for which baseline imbalance is suggested, and baseline levels of variable being analysis (where appropriate, ANCOVA model).

Significance and Precision: The analyses specified will use a 5% significance level with 95% confidence intervals. Given the previous evidence in this area,10 and the clear hypotheses that are being examined, one-tailed significance testing will be adopted. To reduce multiple testing, significance tests for measures with multiple sub-scores will use global tests with multiple degrees of freedom.

Model checking: For models assuming continuous responses Q-Q plots of residuals will be examined.

First phase analysis - immediate post-treatment outcomes
Analysis 1 will focus initially on the primary outcome measure (autism symptoms) through an investigation of AOSI Total Scores at Follow-up Assessment 1. The Follow-up Assessment 1 AOSI Total Score (dependent variable) is a continuous variable and will be analysed using regression, with intervention group (iBASIS-VIPP vs. treatment as usual) as the independent variable of interest, and covarying for baseline AOSI Total Score (ANCOVA framework).

Further analyses will focus on the trial’s secondary outcome variables at follow-up 1.

MACI
The following MACI scores will be investigated: Caregiver sensitive responsiveness, caregiver nondirectiveness, infant attentiveness, and infant positive affect. These will be analysed as a four-outcome regression using an estimating equations approach with unstructured working correlation matrix (equivalent to MANOVA in complete data case) with a 4df significance test reported, again with (iBASIS-VIPP vs. TAU) as the independent variable, and covarying for baseline measures.

MSEL Receptive Language, Expressive Language, Visual Reception, and Fine Motor subscales
The distribution of the endpoint T-scores on the Receptive Language, Expressive Language, Visual Reception, and Fine Motor subscales will be examined for evidence of floor effects. In their absence, these variables will be analysed as a two-outcome regression using an estimating equations approach with unstructured working correlation matrix (equivalent to MANOVA in complete data case) with a 2df significance test reported, again with treatment group (iBASIS-VIPP vs. TAU) as the independent variable of interest, and covarying for baseline measures. Where floor effects are evident – even for raw scores – separate tobit regressions will be estimated. Analyses may or may not covary for baseline scores.

VABS-2 Communication and Socialization domains
The distribution of the endpoint VABS-2 Communication and Socialization domain Standard Scores will be examined for evidence of floor effects. In their absence, the Standard Scores will be analysed as a two-outcome regression using an estimating equations approach with unstructured working correlation matrix (equivalent to MANOVA in complete data case) with a 2df significance test reported. Where floor effects are evident, separate tobit regressions will be estimated, and analyses will not covary for baseline VABS-2 scores.

MCDI
Receptive Vocabulary Count, Expressive Vocabulary Count, Total Gestures score
For receptive and expressive vocabulary counts, analysis will follow the same pattern as for MSEL. However, there will be no covariation for baseline scores. Total gesture score will be analysed as a continuous variable using ANCOVA, with intervention group (iBASIS-VIPP vs. treatment as usual) as the independent variable, and covarying for baseline total score.

PSOC
Parenting Satisfaction, Efficacy and Interest subscales
The three PSOC subscales will be analyzed as a three-outcome regression using an estimating equations approach with unstructured working correlation matrix (equivalent to MANOVA in complete data case) with a 3df significance test reported, covarying for baseline.

Second phase analysis – medium-term post-treatment outcomes
Analysis of the primary outcome (autism symptoms) will follow a procedure described in Green et al. (2017), which combines treatment effect estimates assessed using different tools across time to measure a related outcome, this being the Follow-up Assessment 1 (AOSI Total Score), Follow-up Assessment 2 (ADOS-2 Total Algorithm score) and follow up assessment 3 (ADOS-2 Total Algorithm Score) data using Seemingly Unrelated Regressions11 estimated by maximum likelihood using the SEM procedure using the mlmv option in Stata12, or equivalent packages in R. This method allows a set of treatment effect regressions to have different error variances and different predictors but nonetheless recognises that the regressions involve the same participants and adjusts for their correlation. Combining occasion-specific estimates of treatment effect can give increased power, not least because it improves the reliability of the post-treatment characterisation.

A Cohen’s d effect size for each measure will be calculated using the within-group standard deviation of the outcome at each assessment occasion. Each analysis will covary for relevant baseline measure value, in addition to key prespecified variables of site, age-at-assessment and treatment group assignment. The mlmv method option uses a full-information maximum likelihood estimator in which records with missing outcomes are included in the analysis and treated under an assumption of missing at random. To summarise the treatment group differences in a principled fashion, the multiple point estimates will be combined into an area between the curves. A Wald test for this estimated area will be calculated from the individual effect estimates and their parameter covariance using the lincom procedure. Confidence intervals for area effect sizes will also be obtained by boot-strapping, resampling participants with replacement.

Further analyses will follow the same statistical analysis procedure as described for the primary analysis, but with a focus on secondary outcome variables. These are described below:

MACI
The following MACI scores will be the dependent variables: Caregiver sensitive responsiveness, caregiver nondirectiveness, infant attentiveness, and infant positive affect. Videos recorded at baseline and follow-up assessment 1 will be coded according to the ‘Infant’ version of the MACI, and videos recorded at follow-up assessments 2 and 3 will be coded according to the ‘Toddler’ version of the MACI. Each score will be analysed separately.

MSEL
The following MSEL subscale scores will be the dependent variables: Receptive Language, Expressive Language, Visual Reception, and Fine Motor. If floor effects are apparent at follow- up assessment 1, 2 or 3, then the analyses will use raw subscale score with covariate for age at assessment. In the absence of floor effects at this time point, the analysis will focus on subscale T-scores. Subscales will be analysed separately.

VABS-2
The following VABS-2 subscale scores will be the dependent variables: Communication and Socialization domain Standard Scores. If floor effects are apparent at follow- up assessment 1, 2 or 3, then the analyses will use domain raw scores with covariate for age at assessment. In the absence of floor effects at this time point, the analysis will focus on domain Standard Scores. Domains will be analysed separately.

MCDI
The following MCDI scales will be the dependent variables: Receptive Vocabulary Count (understands + understands and says) and Expressive Vocabulary Count (understands and says). The two scales will be analysed separately.

PSOC
The following PSOC scales will act as dependent variables: Parenting Satisfaction, Efficacy and Interest subscales. Each of the three scales will be analysed separately.

Best estimate clinical judgment of diagnostic status
In line with Green et al., (2017), diagnostic status will be categorised into three groups: ‘clinical ASD’ (coded by consensus diagnosticians as ‘definite ASD’), ‘atypical development’ (coded as ‘possible ASD’ or ‘other developmental concerns’), and ‘typically developing’ (coded as ‘no developmental concerns’). Fisher’s exact test and ordinal logistic models will be used to examine differences between the intervention and TAU groups in the diagnostic status categories (2 X 3 matrix).

Fisher’s exact test and ordinal logistic models will be used to compare the proportion of participants in the intervention and TAU groups meeting each of the 7 criteria for ASD diagnosis (e.g., A1, A2, A3, B1, B2, B3, B4). Consensus diagnostician ratings will be grouped into either ’met’ (coded as ‘met’) and ‘not met’ (coded as ‘not met’ or ‘partially met’), creating a 2 (intervention vs TAU) X 2 (met vs mot met) matrix for each criterion.



REFERENCE
Green J, Pickles A, Pasco G, Bedford R, Wan MW, Elsabbagh M, et al. Randomised trial of a parent-mediated intervention for infants at high risk for autism: longitudinal outcomes to age 3 years. Journal of Child Psychology and Psychiatry. 2017;58(12):1330-40

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
9/06/2016
Date of last participant enrolment
Anticipated
31/12/2017
Actual
30/03/2018
Date of last data collection
Anticipated
31/03/2020
Actual
15/04/2020
Sample size
Target
132
Accrual to date
Final
104
Recruitment in Australia
Recruitment state(s)
WA,VIC

Funding & Sponsors
Funding source category [1] 293780 0
Government body
Name [1] 293780 0
Telethon-Perth Children's Hospital Research Fund
Country [1] 293780 0
Australia
Funding source category [2] 293782 0
Charities/Societies/Foundations
Name [2] 293782 0
Angela Wright-Bennett Foundation
Country [2] 293782 0
Australia
Funding source category [3] 293783 0
University
Name [3] 293783 0
La Trobe University: RFA understanding Disease
Country [3] 293783 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Telethon Kid's Institute
Address
100 Roberts Rd,
Subiaco WA 6008
Australia
Country
Australia
Secondary sponsor category [1] 292617 0
University
Name [1] 292617 0
La Trobe University
Address [1] 292617 0
La Trobe University
Melbourne VIC 3086
Australia
Country [1] 292617 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295219 0
Princess Margaret Hospital Human Research Ethics Committee
Ethics committee address [1] 295219 0
Princess Margaret Hospital
Roberts Road, Subiaco, Perth
Western Australia 6008
Australia
Ethics committee country [1] 295219 0
Australia
Date submitted for ethics approval [1] 295219 0
08/12/2015
Approval date [1] 295219 0
03/03/2016
Ethics approval number [1] 295219 0
2016008EP

Summary
Brief summary
Autism Spectrum Disorder (ASD) is a lifelong developmental disorder affecting more than 1% of people. Social and communication therapies during early childhood are critical for promoting favourable longer-term outcomes in ASD. However, until very recently we have not had interventions tailored towards infants (<14 months of age) who are at increased risk for ASD. iBASIS-VIPP is a parent-mediated intervention in which therapists use video-feedback to help parents adapt to their infants’ interactive styles and promote optimal social and communicative development. Previous research has also shown that the iBASIS-VIPP protocol has preliminary efficacy for improving the developmental outcomes among infants who are at high risk of developing ASD because an older sibling had the condition. The next stage of this research programme is to test the iBASIS-VIPP intervention with infants presenting to a clinical setting with ASD risk-behaviours, such as social and communication delays.

The study design is a two-site (Perth, Melbourne), two-arm (‘Treatment as Usual’, ‘iBASIS-VIPP'), single-blind (rater) randomized controlled trial (RCT). We will recruit 132 infants (n = 66 at each site) who are between 9 and 14-months of age and showing ASD-risk behaviours (social and/or communication difficulties). Consenting families will be randomized into receiving either the ‘iBASIS-VIPP Therapy’ (n = 66) or ‘Treatment as Usual’. Families in the ‘iBASIS-VIPP Therapy’ group will receive 10 home-based sessions with a Speech Pathologist or Psychologist over five months, and undertake 30-minutes daily home practice. Families in the ‘Treatment as Usual’ group may receive a parent information seminar, the provision of reading material on infant development, or developmental monitoring, which is the current ‘best practice’ protocol for these infants. Infants in both groups will be re-assessed follow-up points, time-locked to baseline assessments: (1) 6 months post-baseline (i.e., immediately post ‘treatment’ period), (2) 12- months post-baseline, and (3) 24-months post-baseline. The primary outcome will be autistic symptom severity immediately post treatment (measured by the AOSI). Secondary outcomes will be a range of social and communicative behaviours relevant to ASD at each of the three follow-up points.
Trial website
Trial related presentations / publications
Green J, Wan M, Guiraud J, Holsgrove S, McNally J, Slonims V, et al. Intervention for infants at risk of developing autism. J Autism Dev Disord. 2013;43(11):2502-14.
Green J, Charman T, Pickles A, Wan MW, Slonims V, et al. Parent-mediated intervention versus no intervention for infants at high risk of autism. Lancet Psychiatr. 2(2):133-40.
Public notes

Contacts
Principal investigator
Name 66566 0
Prof Andrew Whitehouse
Address 66566 0
Telethon Kids Institute
100 Roberts Rd
Subacio WA 6008
Australia
Country 66566 0
Australia
Phone 66566 0
+61 8 9489 7777
Fax 66566 0
+61 8 9489 7700
Email 66566 0
Andrew.Whitehouse@telethonkids.org.au
Contact person for public queries
Name 66567 0
Dr Dr Kandice Varcin
Address 66567 0
Telethon Kids Institute
100 Roberts Rd
Subacio WA 6008
Australia
Country 66567 0
Australia
Phone 66567 0
+61 8 9489 7777
Fax 66567 0
+61 8 9489 7700
Email 66567 0
Kandice.Varcin@telethonkids.org.au
Contact person for scientific queries
Name 66568 0
Dr Dr Kandice Varcin
Address 66568 0
Telethon Kids Institute
100 Roberts Rd
Subacio WA 6008
Australia
Country 66568 0
Australia
Phone 66568 0
+61 8 9489 7777
Fax 66568 0
+61 8 9489 7700
Email 66568 0
Kandice.Varcin@telethonkids.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Whitehouse AJO, Varcin KJ, Alvares GA, et al. Pre-... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePre-emptive intervention versus treatment as usual for infants showing early behavioural risk signs of autism spectrum disorder: a single-blind, randomised controlled trial.2019https://dx.doi.org/10.1016/S2352-4642%2819%2930184-1
EmbaseEffect of Preemptive Intervention on Developmental Outcomes among Infants Showing Early Signs of Autism: A Randomized Clinical Trial of Outcomes to Diagnosis.2021https://dx.doi.org/10.1001/jamapediatrics.2021.3298
N.B. These documents automatically identified may not have been verified by the study sponsor.