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Trial registered on ANZCTR


Registration number
ACTRN12623000612617
Ethics application status
Approved
Date submitted
21/05/2023
Date registered
5/06/2023
Date last updated
1/06/2024
Date data sharing statement initially provided
5/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
E-PACT: Randomised Trial of Parenting Acceptance and Commitment therapy for Parents of children with neurodevelopmental disabilities
Scientific title
E-PACT: Randomised Trial of Parenting Acceptance and Commitment Therapy for Parents of children diagnosed with or with increased chance of neurodevelopmental disability or developmental delay
Secondary ID [1] 309659 0
None
Universal Trial Number (UTN)
U1111-1292-7794
Trial acronym
E-PACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurodevelopmental disabilities 330000 0
Parenting children with neurodevelopmental disabilities 330001 0
Condition category
Condition code
Neurological 326908 326908 0 0
Other neurological disorders
Mental Health 326918 326918 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
E-PACT is an online/telehealth parent support intervention developed in partnership with
parents and focussed on growing parent capacity. E-PACT (“Parenting with Acceptance and
Commitment Therapy”) was developed grounded in acceptance and commitment therapy
(ACT), a type of cognitive behavioural therapy (CBT) that targets psychological flexibility: the
“ability to persist or change one’s behaviour, with full and flexible awareness of the situational
context and one’s own present-moment experience, in the service of chosen values”. Core to
ACT is acknowledgement of the universality of suffering, and the importance of living a
meaningful life through effective action and focusing on what works, themes that resonate for parents of children with neurodevelopmental disabilities (NDD).

E-PACT will support parents to grow parent capacity by cultivating flexible, sensitive, and
effective parenting through developing:
• Effective strategies for teaching new skills, and encouraging positive behaviour
• Effective strategies for managing misbehaviour
• Effective strategies for interacting with the wider community
• Awareness of their own and their child’s (developing) values
• Awareness of effective action, i.e., what works
• Insightfulness, understanding the child’s perspective
• Experiential acceptance, the ability to live with distressing emotions, cognitions, and memories
as they arise, and continue to focus on effective action
• Acceptance of their child and their child’s emotions, cognitions etc.
• Self-compassion & achievable self-care repertoires

It will include an EdX course and clinician consultations.

E-PACT EdX course: 12-week EdX course, includes videos, text, multiple choice questions, real life activities (e.g., practising mindfulness during a parent-child interaction), and a discussion board facilitated by the E-PACT clinicians. The course contains six modules (one module per fortnight across 12-weeks), with modules taking approximately one hour each to complete. E-PACT is delivered via the edX platform, freely available and fully supported at the University of Queensland. Module engagement will be tracked via participants' completion of questions related to program feasibility and acceptability shown at the end of each module.

Clinician Support: One-on-one clinician consultations (30 minutes per fortnight across the 12-week course) will support parents in understanding and acting on E-PACT content, taking a flexible goal-directed approach. Clinician consultations will focus on: parental goals, parental application in real life, overcoming obstacles, and integrating flexibility into parent-child interactions. Clinician consultations will be conducted via ZOOM. They will be recorded and assessed for adherence to protocol and session attendance logs will be kept. Parents will choose three goals for change (i) a parent-child relationship or parenting goal, (ii) a parental self-care or health behaviour goal, and (iii) a child behaviour/adjustment goal.

E-PACT is supported by trained allied health clinicians providing individualised feedback and
additional support to specific families. It thus offers a translatable and scalable universal online support with additional telehealth components for families who need it.
Intervention code [1] 326094 0
Behaviour
Comparator / control treatment
The Care as Usual group will be randomised to receive their usual services from baseline (T1) for six months (T3) and will then be offered the E-PACT intervention after completing follow-up assessment (at 6 months post baseline). The E-PACT program is secure and unable to be accessed by external parties during the study period, so no between-group contamination is possible
Control group
Active

Outcomes
Primary outcome [1] 334748 0
The quality of the parent-child relationship as measured by the Emotional Availability Scales (EAS).
Timepoint [1] 334748 0
Baseline, 12 weeks after starting intervention (primary timepoint), 6-month follow-up
Primary outcome [2] 334749 0
Parent emotional availability within the parent-child relationship as measured by the emotional Availability-Self Report (EA-SR).
Timepoint [2] 334749 0
Baseline, 12 weeks after starting intervention (primary timepoint), 6-month follow-up
Secondary outcome [1] 421945 0
Composite measure of parent depression, anxiety, and stress as measured by the Depression Anxiety Stress Scales (DASS-21)
Timepoint [1] 421945 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [2] 421963 0
Parent health behaviours as measured by the Good Health Practices Scale (GHPS)
Timepoint [2] 421963 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [3] 421964 0
Parental adjustment to a child’s chronic illness as measured by the Parent Experience of Child Illness Scale (PECIS)
Timepoint [3] 421964 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [4] 421965 0
Child behavioural and emotional problems as measured by the Child Behaviour Checklist (CBCL parent report)
Timepoint [4] 421965 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [5] 421966 0
Adaptive behaviour from birth to adulthood (communication, daily living skills, socialisation and motor skills) as measured by the Vineland Adaptive Behaviour Scale Comprehensive (3rd ed. VABS-III parent report)
Timepoint [5] 421966 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [6] 421967 0
Parent’s ability to maintain present-centred attention and emotional awareness during parent-child interactions as measured by Interpersonal Mindfulness in Parenting Scale (IM-P)
Timepoint [6] 421967 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [7] 421968 0
Psychological flexibility as measured by Comprehensive Assessment of Acceptance and Commitment Therapy Processes (Com-PACT)
Timepoint [7] 421968 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [8] 421976 0
Participants' ratings of the E-PACT intervention in terms of acceptability and feasibility (custom composite measure designed specifically for the program).
Timepoint [8] 421976 0
Measured six times, at the end of each of the intervention modules.
Secondary outcome [9] 421982 0
Health-related quality of life as measured by EuroQol five-dimension five-levels (EQ-5D-5L).
Timepoint [9] 421982 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [10] 421984 0
Composite measure of caregiver burden and care-related quality of life as measured by Carer Experience Scale (CES)
Timepoint [10] 421984 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [11] 422427 0
Parent nominated goal for change related to parent-child relationship or parenting, as measured by the Goal Attainment Scale (GAS).
Timepoint [11] 422427 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [12] 422428 0
Parent nominated goal for change related to parental self-care or health behaviour, as measured by the Goal Attainment Scale (GAS).
Timepoint [12] 422428 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [13] 422429 0
Parent nominated goal for change related to child behaviour/adjustment as measured by the Goal Attainment Scale (GAS).
Timepoint [13] 422429 0
Baseline, 12 weeks after starting intervention, 6-month follow-up
Secondary outcome [14] 422431 0
Changes in parent self-regulatory abilities as measured by a wearable heart rate variability (HRV) monitor.
Timepoint [14] 422431 0
Baseline, 12 weeks after starting intervention, 6-month follow-up. Parent HRV data will be collected by parents on waking for 5 consecutive days at each timepoint.
Secondary outcome [15] 422432 0
Changes in child self-regulatory abilities as measured by a wearable heart rate variability (HRV) monitor.
Timepoint [15] 422432 0
Baseline, 12 weeks after starting intervention, 6-month follow-up. Child HRV data will be collected by parents on waking for 5 consecutive days at each timepoint.

Eligibility
Key inclusion criteria
Families must have a child 0-10 years of age with either a diagnosis of a NDD or assessed as increased chance of a NDD (including Cerebral Palsy, Autism, Fetal Alcohol Spectrum Disorder). Children will be considered assessed as increased chance of a NDD on the basis of one of the following: (1) diagnosis of developmental delay coupled with eligibility for NDIS, (2) previous assessment as increased chance of Cerebral Palsy using the General Movements Assessment (GMA) or Hammersmith Infant Neurological assessment or (3) previous assessment as high-risk of ASD using the Social Attention and Communication Surveillance Revised (SAC-R) or the ASDetect mobile application. These inclusions are consistent with the latest practice in international Clinical Practice Guidelines for the early identification of Cerebral Palsy and Autism Spectrum Disorder.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential parent participants who are unable to understand the written information sheet will be excluded from the study, as the intervention includes materials written in the English language, and the study requires participants to complete sets of online questionnaires written in the English language. Any families who would be excluded from the study on the basis of language will be referred to other services as appropriate.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Central computer-generated block randomisation (1:1)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
To detect a difference of 0.35SD on the Emotional Availability Scales (EAS) with power of 0.80 and alpha= 0.05 a total sample size of 258 families is required (129 in each group). To account for expected attrition of 11-15% (from previous trials) we will recruit 300 families.

The primary outcome will be analysed using linear regression with treatment (E-PACT/CAU) included as the main effect. Secondary comparisons will be conducted using linear models for continuous outcomes, logistic models for binary outcomes and Poisson models for count outcomes. The value of the outcome variable at baseline will be included as a covariable when appropriate. When repeated measures are analysed the non-independence of results from the same family will be accounted for using mixed-effects models. Sub-group analyses will compare by age and child diagnosis. Analysis will follow standard principles for RCTs with two-group comparisons using the intention-to-treat principle.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
24/07/2023
Actual
26/02/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
300
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Funding & Sponsors
Funding source category [1] 313852 0
Government body
Name [1] 313852 0
Australian Government Department of Health and Aged Care, Medical Research Future Fund (MRFF)
Country [1] 313852 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
The University of Queensland
St Lucia QLD 4072
Country
Australia
Secondary sponsor category [1] 315691 0
None
Name [1] 315691 0
Address [1] 315691 0
Country [1] 315691 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313000 0
The University of Queensland Human Research Ethics Committee
Ethics committee address [1] 313000 0
Cumbrae-Stewart Building The University of Queensland St Lucia QLD 4072
Ethics committee country [1] 313000 0
Australia
Date submitted for ethics approval [1] 313000 0
Approval date [1] 313000 0
04/05/2023
Ethics approval number [1] 313000 0
2023/HE000040

Summary
Brief summary
This proposal is a type-1 hybrid randomised controlled trial, focussing on effectiveness and
implementation. Our aim is to grow the capacity of parents of children with neurodevelopmental disabilities (NDD) to continue to effectively implement and manage ongoing interventions for their children, with an easily translatable online/telehealth intervention: E-PACT.

Parent capacity is underpinned by multiple factors including physical and mental health and is associated with multiple child outcomes. Our primary outcome is parent capacity itself, specifically the core parenting competency: emotional availability measured on the Emotional Availability Scale (EAS). Secondary outcomes include parent and child physical and mental health. Tertiary outcomes will measure the cost and consequences, barriers and facilitators of E-PACT delivery compared to Care as usual to inform implementation.

We will conduct a phase III RCT of an online/telehealth intervention E-PACT with 300 families of children with NDD. This is a two-arm RCT in which families of a child (0-10 years) with a diagnosis of an NDD or assessed as increased chance of a NDD will be randomly assigned to E-PACT or Care As Usual (CAU) with follow-up until 6 months post baseline. All families will complete pre-intervention assessment at baseline (T1), post-intervention assessment (T2), and 6 months follow up (T3 6 months post baseline). Families in the CAU group will then be provided with E-PACT after completion of the six months follow up (wait-list control).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126638 0
Dr Koa Whittingham
Address 126638 0
UQ Child Health Research Centre,
62 Graham Street
South Brisbane, QLD 4101
Country 126638 0
Australia
Phone 126638 0
+61 7 3069 7346
Fax 126638 0
Email 126638 0
koawhittingham@uq.edu.au
Contact person for public queries
Name 126639 0
Dr Koa Whittingham
Address 126639 0
UQ Child Health Research Centre,
62 Graham Street
South Brisbane, QLD 4101
Country 126639 0
Australia
Phone 126639 0
+61 7 3069 7346
Fax 126639 0
Email 126639 0
koawhittingham@uq.edu.au
Contact person for scientific queries
Name 126640 0
Dr Koa Whittingham
Address 126640 0
UQ Child Health Research Centre,
62 Graham Street
South Brisbane, QLD 4101
Country 126640 0
Australia
Phone 126640 0
+61 7 3069 7346
Fax 126640 0
Email 126640 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
No additional documents have been identified.