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DEFINITIONS
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
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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
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Secondary ID [1]
296690
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None
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Universal Trial Number (UTN)
U1111-1224-6536
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Trial acronym
ENACT (ENvironmental enrichment for infants; parenting with Acceptance and Commitment Therapy)
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder
310534
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Condition category
Condition code
Mental Health
309245
309245
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0
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Autistic spectrum disorders
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
313001
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Behaviour
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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.
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Control group
Active
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Outcomes
Primary outcome [1]
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Infant development and autism symptomatology will be measured using the Autism Observation Schedule in Infants (AOSI).
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Assessment method [1]
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Timepoint [1]
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12 months of age (primary endpoint)
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Primary outcome [2]
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Parental mental health will be assessed using the Depression, Anxiety and Stress Scale (DASS)
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Assessment method [2]
321490
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Timepoint [2]
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Baseline, 3 months, 6 months of age and 12 months
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Secondary outcome [1]
354267
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Infant's spontaneous motor activity as a marker of adverse neurological outcomes will be measured using the General Movements Assessment
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Assessment method [1]
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Timepoint [1]
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3 months of age
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Secondary outcome [2]
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The Hammersmith Infant Neurological Examination (HINE) will be used to measure infant sensorimotor skills.
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Assessment method [2]
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Timepoint [2]
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6 months and 12 months of age
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Secondary outcome [3]
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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.
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Assessment method [3]
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Timepoint [3]
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6 months and 12 months of age
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Secondary outcome [4]
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Infant adaptive skills will be measured using the Vineland Adaptive Behaviour Scale (3rd edition; VABS-III)
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Assessment method [4]
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Timepoint [4]
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12 months of age
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Secondary outcome [5]
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Infant visual perception skills will be measured on the Communication and Symbolic Behavior Scales Developmental Profile Infant-Toddler Checklist (CSBS DP ITC)
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Assessment method [5]
354973
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Timepoint [5]
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6 months and 12 months of age
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Secondary outcome [6]
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Infant sleep patterns will be measured using the Brief Infant Sleep Questionnaire (BISQ)
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Assessment method [6]
354974
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Timepoint [6]
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3 months and 6 months of age
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Secondary outcome [7]
354975
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Changes in infant regulation will be measured through the Infant Toddler Social & Emotional Assessment (ITSEA) scale,
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Assessment method [7]
354975
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Timepoint [7]
354975
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12 months of age
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Secondary outcome [8]
354976
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Infant regulation and crying patterns will be measured using the Crying Patterns Questionnaire (CPQ)
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Assessment method [8]
354976
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Timepoint [8]
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3 months and 6 months of age
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Secondary outcome [9]
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Infant visual attention will be measured using The Gap-Overlap task
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Assessment method [9]
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Timepoint [9]
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6 months and 12 months of age
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Secondary outcome [10]
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Parent-infant interaction and emotional availability will be measured using the Emotional Availability Scales (EAS) Self-Report
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Assessment method [10]
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Timepoint [10]
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3 months, 6 months and 12 months of age
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Secondary outcome [11]
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Parent infant interaction and emotional availability will be coded using the Emotional Availability Scales (EAS) Observation
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Assessment method [11]
375102
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Timepoint [11]
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6 months of age and 12 months of age
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Infants with a known neurological or chromosomal disorder at the point of recruitment will be excluded.
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is concealed through central randomisation by computer.
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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.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/09/2019
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Actual
16/09/2019
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
66
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Accrual to date
0
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Final
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
12725
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Lady Cilento Children's Hospital - South Brisbane
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Recruitment postcode(s) [1]
25152
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4101 - South Brisbane
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Funding & Sponsors
Funding source category [1]
301474
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University
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Name [1]
301474
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University of Queensland
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Address [1]
301474
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The University of Queensland
St Lucia
QLD 4072
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Country [1]
301474
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Australia
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Primary sponsor type
Individual
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Name
Dr Koa Whittingham
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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
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Country
Australia
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Secondary sponsor category [1]
300909
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Individual
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Name [1]
300909
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Kavindri Kulasinghe
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Address [1]
300909
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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
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Country [1]
300909
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Australia
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Secondary sponsor category [2]
300912
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Individual
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Name [2]
300912
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Dr Andrea McGlade
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Address [2]
300912
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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
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Country [2]
300912
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Australia
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Secondary sponsor category [3]
300913
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Individual
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Name [3]
300913
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Prof Rosyln Boyd
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Address [3]
300913
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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
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Country [3]
300913
0
Australia
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Secondary sponsor category [4]
300914
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Individual
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Name [4]
300914
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Dr Amy Mitchell
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Address [4]
300914
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Parenting and Family Support Centre
School of Psychology
The University of Queensland
13 Upland Road
St Lucia
Queensland 4072
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Country [4]
300914
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Australia
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Secondary sponsor category [5]
304035
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Individual
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Name [5]
304035
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Associate Professor Honey Heussler
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Address [5]
304035
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Queensland Children's Hospital, 501 Stanley St, South Brisbane, QLD 4101
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Country [5]
304035
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Australia
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Secondary sponsor category [6]
304036
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Individual
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Name [6]
304036
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Dr Kristelle Hudry
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Address [6]
304036
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Olga Tennison Autism Research Centre
Kingsbury Drive
Bundoora
VIC 3083
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Country [6]
304036
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302010
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Children's Health Queensland Hospital and Health Service Human Research Ethics Committee
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Ethics committee address [1]
302010
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Level 6, Centre for Children’s Health Research
Lady Cilento Children’s Hospital Precinct
62 Graham Street
South Brisbane QLD 4101
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Ethics committee country [1]
302010
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Australia
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Date submitted for ethics approval [1]
302010
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21/01/2019
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Approval date [1]
302010
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26/02/2019
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Ethics approval number [1]
302010
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HREC/19/QCHQ/50131
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Ethics committee name [2]
302013
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The University of Queensland Human Research Ethics Committee
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Ethics committee address [2]
302013
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Cumbrae-Stewart Building
The University of Queensland
St Lucia QLD 4072
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Ethics committee country [2]
302013
0
Australia
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Date submitted for ethics approval [2]
302013
0
21/01/2019
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Approval date [2]
302013
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08/04/2019
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Ethics approval number [2]
302013
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2019000558
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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.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Dr Koa Whittingham
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Address
88842
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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
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Country
88842
0
Australia
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Phone
88842
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+61 (7) 3646 5539
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Fax
88842
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Email
88842
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[email protected]
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Contact person for public queries
Name
88843
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Dr Koa Whittingham
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Address
88843
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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
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Country
88843
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Australia
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Phone
88843
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+61 (7) 3646 5539
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Fax
88843
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Email
88843
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[email protected]
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Contact person for scientific queries
Name
88844
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Dr Koa Whittingham
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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
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Country
88844
0
Australia
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Phone
88844
0
+61 (7) 3646 5539
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Fax
88844
0
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Email
88844
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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
Source
Title
Year of Publication
DOI
Embase
ENACT (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.
2020
https://dx.doi.org/10.1136/bmjopen-2019-034315
N.B. These documents automatically identified may not have been verified by the study sponsor.
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