Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618002046280
Ethics application status
Approved
Date submitted
18/12/2018
Date registered
21/12/2018
Date last updated
23/09/2019
Date data sharing statement initially provided
21/12/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): an innovative intervention for infants at risk of Autism Spectrum Disorder
Scientific title
ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy): A randomised controlled trial of an innovative intervention targeted at improving the parent-infant interaction and developmental outcomes in infants at risk of Autism Spectrum Disorder
Secondary ID [1] 296690 0
None
Universal Trial Number (UTN)
U1111-1224-6536
Trial acronym
ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 310534 0
Condition category
Condition code
Mental Health 309245 309245 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
ENACT is a very early parenting intervention that is designed for mothers of infants that are at risk of developing Autism Spectrum Disorder. It supports parent-infant interactions, targets parent-infant social reciprocity and supports parental mental health. The intervention is delivered online using the edX platform and is available to mothers when they are 6-8 months pregnant. The course uses acceptance and commitment therapy (ACT) to support parenting and parental mental health and contains a teaching component that is designed to support parental responsiveness and non-intrusivness, and promote social reciprocity in infants. The course contains educational videos, homework assignments, discussion boards, educational activities, journal and reflection activities and mindfulness exercises. The ENACT online course consists of 5 modules and mothers are encouraged to move through the course at their own pace, with the goal that the mothers will complete the course before their baby is 8 weeks of age. Participants will also be offered fortnightly 20-30 minute video conferencing sessions with a clinician (a health professional with early intervention experience who has been trained ad supervised in the ENACT protocol) to support them as they move through the course. Website analytics on the edX platform will be used to monitor the completion of activities within the ENACT course. When their infant is 2 weeks of age, mothers will be encouraged to practice sensitivity chains with their infants, with a goal dose of 30 minutes a day/5 days a week until their infant is 12 months of age. This practice can be integrated into everyday interactions between the parent and the child. Participants will also be supported by regular clinician consultations over regular video conferencing sessions until the infant is 10 months of age.
Intervention code [1] 313001 0
Behaviour
Comparator / control treatment
The control group will be allocated to care as usual. This is not based upon specific clinical practice guidelines. Families that are allocated to this condition will receive their regular postnatal medical care. At the 6 month and 12 month follow up assessment, the care as usual families will be offered a developmental assessment and report for their infant.
Control group
Active

Outcomes
Primary outcome [1] 308218 0
Infant development and autism symptomatology will be measured using the Autism Observation Schedule in Infants (AOSI).
Timepoint [1] 308218 0
12 months of age (primary endpoint)
Primary outcome [2] 321490 0
Parental mental health will be assessed using the Depression, Anxiety and Stress Scale (DASS)
Timepoint [2] 321490 0
Baseline, 3 months, 6 months of age and 12 months
Secondary outcome [1] 354267 0
Infant's spontaneous motor activity as a marker of adverse neurological outcomes will be measured using the General Movements Assessment
Timepoint [1] 354267 0
3 months of age
Secondary outcome [2] 354708 0
The Hammersmith Infant Neurological Examination (HINE) will be used to measure infant sensorimotor skills.
Timepoint [2] 354708 0
6 months and 12 months of age
Secondary outcome [3] 354971 0
Child cognitive development will be measured using the Early Learning Composite (ELC) of the Mullen Scale for Early Learning (MSEL), which contains the sub-domains of Visual Reception, Fine Motor, Receptive Language and Expressive Language.
Timepoint [3] 354971 0
6 months and 12 months of age
Secondary outcome [4] 354972 0
Infant adaptive skills will be measured using the Vineland Adaptive Behaviour Scale (3rd edition; VABS-III)
Timepoint [4] 354972 0
12 months of age
Secondary outcome [5] 354973 0
Infant visual perception skills will be measured on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist (CSBS DP ITC)
Timepoint [5] 354973 0
6 months and 12 months of age
Secondary outcome [6] 354974 0
Infant sleep patterns will be measured using the Brief Infant Sleep Questionnaire (BISQ)
Timepoint [6] 354974 0
3 months and 6 months of age
Secondary outcome [7] 354975 0
Changes in infant regulation will be measured through the Infant Toddler Social & Emotional Assessment (ITSEA) scale,
Timepoint [7] 354975 0
12 months of age
Secondary outcome [8] 354976 0
Infant regulation and crying patterns will be measured using the Crying Patterns Questionnaire (CPQ)
Timepoint [8] 354976 0
3 months and 6 months of age
Secondary outcome [9] 354985 0
Infant visual attention will be measured using The Gap-Overlap task
Timepoint [9] 354985 0
6 months and 12 months of age
Secondary outcome [10] 375101 0
Parent-infant interaction and emotional availability will be measured using the Emotional Availability Scales (EAS) Self-Report
Timepoint [10] 375101 0
3 months, 6 months and 12 months of age
Secondary outcome [11] 375102 0
Parent infant interaction and emotional availability will be coded using the Emotional Availability Scales (EAS) Observation
Timepoint [11] 375102 0
6 months of age and 12 months of age

Eligibility
Key inclusion criteria
To be included in the study potential participants must meet the following inclusion criteria: (1) the infant must have one or more biological siblings or a biological parent diagnosed with Autism Spectrum Disorder; (2) the mother must agree to assessment requirements; (3) the mother must have reliable internet access; and (4) the mother must have sufficient English to complete the assessments.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Infants with a known neurological or chromosomal disorder at the point of recruitment will be excluded.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation will be conducted using a computer-generated random number generator.
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/09/2019
Actual
16/09/2019
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
66
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 12725 0
Lady Cilento Children's Hospital - South Brisbane
Recruitment postcode(s) [1] 25152 0
4101 - South Brisbane

Funding & Sponsors
Funding source category [1] 301474 0
University
Name [1] 301474 0
University of Queensland
Country [1] 301474 0
Australia
Primary sponsor type
Individual
Name
Dr Koa Whittingham
Address
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country
Australia
Secondary sponsor category [1] 300909 0
Individual
Name [1] 300909 0
Kavindri Kulasinghe
Address [1] 300909 0
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country [1] 300909 0
Australia
Secondary sponsor category [2] 300912 0
Individual
Name [2] 300912 0
Dr Andrea McGlade
Address [2] 300912 0
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country [2] 300912 0
Australia
Secondary sponsor category [3] 300913 0
Individual
Name [3] 300913 0
Prof Rosyln Boyd
Address [3] 300913 0
Queensland Cerebral Palsy and Rehabilitation Research Centre, The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country [3] 300913 0
Australia
Secondary sponsor category [4] 300914 0
Individual
Name [4] 300914 0
Dr Amy Mitchell
Address [4] 300914 0
Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia
Queensland 4072
Country [4] 300914 0
Australia
Secondary sponsor category [5] 304035 0
Individual
Name [5] 304035 0
Associate Professor Honey Heussler
Address [5] 304035 0
Queensland Children's Hospital, 501 Stanley St, South Brisbane, QLD 4101
Country [5] 304035 0
Australia
Secondary sponsor category [6] 304036 0
Individual
Name [6] 304036 0
Dr Kristelle Hudry
Address [6] 304036 0
Olga Tennison Autism Research Centre
Kingsbury Drive
Bundoora
VIC 3083
Country [6] 304036 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302010 0
Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
Ethics committee address [1] 302010 0
Level 6, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
Ethics committee country [1] 302010 0
Australia
Date submitted for ethics approval [1] 302010 0
21/01/2019
Approval date [1] 302010 0
26/02/2019
Ethics approval number [1] 302010 0
HREC/19/QCHQ/50131
Ethics committee name [2] 302013 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [2] 302013 0
Cumbrae-Stewart Building
The University of Queensland
St Lucia QLD 4072
Ethics committee country [2] 302013 0
Australia
Date submitted for ethics approval [2] 302013 0
21/01/2019
Approval date [2] 302013 0
08/04/2019
Ethics approval number [2] 302013 0
2019000558

Summary
Brief summary
Infants with a family history of Autism Spectrum Disorder are at an increased risk of developing this disorder themselves. The provision of an early Acceptance and Commitment (ACT)-based therapy intervention aims to improve clinical outcomes for these infants by enriching parent-infant interactions, assisting with infant sleep, crying and fuss behaviours and supporting parental mental health. A randomised controlled trial will evaluate whether this intervention for parents of infants at risk of Autism Spectrum Disorder is effective, comparing this intervention with usual care. We expect that this intervention will improve the emotional availability of the parent-infant interaction, parental mental health as well as infant developmental outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 88842 0
Dr Koa Whittingham
Address 88842 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country 88842 0
Australia
Phone 88842 0
+61 (7) 3646 5539
Fax 88842 0
Email 88842 0
koawhittingham@uq.edu.au
Contact person for public queries
Name 88843 0
Dr Koa Whittingham
Address 88843 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country 88843 0
Australia
Phone 88843 0
+61 (7) 3646 5539
Fax 88843 0
Email 88843 0
koawhittingham@uq.edu.au
Contact person for scientific queries
Name 88844 0
Dr Koa Whittingham
Address 88844 0
Queensland Cerebral Palsy and Rehabilitation Research Centre,
The University of Queensland
Level 6, Centre for Children’s Health Research
62 Graham Street
South Brisbane
Queensland 4101
Country 88844 0
Australia
Phone 88844 0
+61 (7) 3646 5539
Fax 88844 0
Email 88844 0
koawhittingham@uq.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseENACT (ENvironmental enrichment for infants; Parenting with Acceptance and Commitment Therapy): A randomised controlled trial of an innovative intervention for infants at risk of autism spectrum disorder.2020https://dx.doi.org/10.1136/bmjopen-2019-034315
N.B. These documents automatically identified may not have been verified by the study sponsor.