Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000196640
Ethics application status
Approved
Date submitted
6/02/2023
Date registered
23/02/2023
Date last updated
20/03/2023
Date data sharing statement initially provided
23/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising outcomes for families with children with a Fetal Alcohol Spectrum Disorder diagnosis or 'At Risk' designation: A mixed-methods randomised trial of Parents under Pressure and the Alert® Program
Scientific title
Assessing the effect of the Parents under Pressure and the Alert® Program on children's global executive functioning for children with a Fetal Alcohol Spectrum Disorder diagnosis or 'At Risk' designation
Secondary ID [1] 308608 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Fetal Alcohol Spectrum Disorder 328499 0
Prenatal Alcohol Exposure 328500 0
Condition category
Condition code
Mental Health 325529 325529 0 0
Other mental health disorders
Neurological 326047 326047 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parents Under Pressure
The Parents under Pressure (PuP) Program is a home-based intervention based on a systemic and strengths-based framework, drawing on theoretical influences that include attachment, behavioural parenting, and emotional regulation. The PuP program is individually tailored to each family using a case formulation process. The delivery of the PuP program is guided by a Practitioner Manual and practitioners and families collaborate to develop a therapeutic family support plan with identified goals. A Parent Workbook is also available as additional support to complement sessions. It contains twelve modules addressing different domains of family functioning that may or may not be targeted in a treatment plan. There is a significant focus on enhancing the caregiving relationship and emotional regulation in both parents and children. For example, the module How to Manage Emotions When Under Pressure: Increasing Mindful Awareness integrates mindfulness exercises to enhance parent emotion regulation. The ‘Supporting Your Child to Develop Self-Regulation’ and ‘Connecting With Your Child To Help Them Feel Loved And Safe’ modules provide parents with developmentally appropriate and non-punitive strategies to enhance child self-regulation, including ‘mindful play’, skills for understanding their children’s cognitive and emotional states, and mindfulness techniques to promote sensitive caregiving in stressful parenting contexts.

This trial extends the PuP program to address the needs of families of children with a diagnosis of Fetal Alcohol Spectrum Disorder (FASD) or an 'At Risk' designation (as per the Australian Guidelines). Adaptations to the existing program have been informed by consultation with experienced clinicians in the diagnosis and treatment of FASD, along with the extant treatment literature. There are three ways in which the current study extends the PuP program to comprehensively address the needs of families of children with FASD or an 'At Risk' designation. First, psychoeducation will be provided concerning the child's individual profile of neurodevelopmental strengths and needs, and how this impacts their daily functioning and behaviour. This will be informed by the child’s neurodevelopmental assessment that informed their diagnosis. The caregiver's role in supporting the child’s developing self-regulation will be emphasised, and environmental modifications tailored to the child's profile will be discussed (e.g., anticipating/preparing for challenging situations, using executive instructions and reminders, picture routines or schedules). Second, age-appropriate strategies for enhancing young children's self-regulatory capacities will be introduced to the child and caregiver. PuP practitioners will use play-based approaches to teach child breathing techniques (e.g., using a flickering candle or bubble blowing exercise), mindfulness strategies (e.g., using a storybook, child-friendly tablet apps), emotion identification (e.g., use of visual aids and cartoons), developing coping self-talk or ‘mantras’ with children and caregivers to help the child manage frustration and impulsive behaviour. Third, liaison with the child's teacher will enable any recommended strategies to be generalised to this environment, ensuring consistency of approach and improving child engagement with education.

Allied and mental health practitioners who have undergone the PuP accreditation process will implement the trial (e.g., psychologists, social workers, family support workers). All implementing practitioners will receive regular supervision by a senior PuP trainer and clinical psychologist to ensure fidelity to the program model. In addition, practitioners will be required to complete a short progress note at the end of each session aiming to capture the components of the intervention captured in the session (e.g., Module from the Parent Workbook, the proportion of the intervention focused on emotion regulation). The PuP arm of the trial will run continuously for the duration of the project, with 2 – 3 PuP practitioners holding a maximum caseload of 5 families at any time.

The intervention will be delivered face-to-face individually with each family, predominantly in the home. Some sessions may occur in other settings, as determined by the family’s needs (e.g., child’s school, appointments with other allied health professionals, community agencies). Sessions will be conducted over 12 – 16 weeks for approximately 1 – 2 hours. Families may also be in contact with their PuP practitioner between sessions as needed to problem-solve issues as they arise (e.g., short phone calls or emails). The amount of engagement with the Parent Workbook each week will be at the discretion of the family and/or their PuP practitioner.
Intervention code [1] 325057 0
Treatment: Other
Intervention code [2] 325464 0
Behaviour
Comparator / control treatment
Alert® Program
The Alert® program is an evidence-based intervention for fostering children's self-regulatory capacity. It focuses on enhancing child self- regulation by encouraging integration of cognitive processing, using a car engine analogy, and has been used in Australia and Canada with FASD populations. The current study will adopt the approach used by Nash et al. (2015) for children with FASD, organised into three sequential stages: (1) identifying and labelling 'engine levels' through learning 'engine words' and 'engine speeds'; (2) experimenting with 'engine speeds' and learning regulation strategies; (3) self-selection of strategies for application outside therapy and review of learning.

The intervention will be run in small face-to-face groups over 12 weekly sessions, of 90 minutes duration. The first session will be caregiver-only session focused on explicating the eight key concepts of the Alert® program, with the aim of supporting caregivers in using the Alert® program strategies between therapy sessions. The remaining 11 sessions will be comprised of child-focused group sessions following the sequential stages and associated Mile Markers as per the Alert® program manual and materials. Caregivers will be invited to attend the last 15 minutes of each group session to obtain a summary of the session and how the skills/strategies can be implemented into family routines and parenting. All sessions will occur at a child development clinic located within Griffith University, Queensland. If a parent is unable to attend the first session, it will be offered as a one-on-one session via videoconferencing or in-person. If a child is unable to attend a group session (e.g., due to illness), the family will be offered a one-on-one face-to-face session that is equivalent to the group session content.

Psychologists who have undertaken the Alert® program training will implement the intervention. Psychologists may hold endorsement as per Australian standards (e.g., clinical, neuropsychology) or be actively working towards formal registration (e.g., postgraduate students who are provisionally registered). One Alert® group with a minimum of 3 and a maximum of 6 children will run each school term. All implementing practitioners will receive regular supervision by a senior clinical psychologist and at least 20% of sessions will be observed by a member of the research team who will complete fidelity checklists.
Control group
Active

Outcomes
Primary outcome [1] 333709 0
Child global executive function (indirect) using the Behaviour Rating Inventory of Executive Functioning – 2 (BRIEF-2) and Behaviour Rating Inventory of Executive Functioning – Preschool (BRIEF-P) (Gioia et al., 2003) which are standardised and normed caregiver- and teacher-report measures of behaviours associated with specific aspects of executive functioning in children aged 5 to 18 years and 2 to 5 years 11 months, respectively. This measure will be administered by a secure online platform. The BRIEF-2 has 10 subscales (Inhibit, Self-Monitor, Shift, Emotional Control, Initiate, Working Memory, Plan/Organize, Task Monitor, Organization of Materials), which reduce to Behaviour Regulation, Emotion Regulation and Cognitive Regulation. The BRIEF-P has four subscales (Inhibit, Shift, Emotional Control, Working Memory) that form three broad index scores (Inhibitory Self-Control, Flexibility, and Emergent Metacognition).
Timepoint [1] 333709 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Primary outcome [2] 333748 0
Child behavioural and emotional functioning using the Behaviour System for Children, 3rd Edition (BASC-3; Reynolds & Kamphaus, 2015). The BASC-3 is standardised and normed parent- and teacher-report measure of behavioural and emotional functioning in children aged 2 – 21 years and 11 months. The measure will be administered via a secure online platform. The parent-report version contains (a) composite scales (Adaptive Skills, Behavioural Symptoms Index, Externalising Problems, Internalising Problems); (b) clinical symptom scales (Aggression, Anxiety, Attention Problems, Atypicality, Conduct Problems, Depression, Hyperactivity, Learning Problems, Somatisation, and Withdrawal); (c) content scales (Anger Control, Bullying, Developmental Social Disorders, Emotional Self-Control, Executive Functioning, Negative Emotionality, and Resiliency); (d) adaptive scales (Activities of Daily Living, Adaptability, Functional Communication, Leadership, Social Skills, and Study Skills); and (e) probability, impairment and executive function indices (Clinical Probability Index, Emotional Behavioural Disorder Probability Index, Autism Probability Index, Attention-Deficit/Hyperactivity Disorder Probability Index, Functional Impairment Index, Executive Functioning Indexes (Problem- Solving, Attentional Control, Behavioural Control, Emotional Control, and Overall)). The teacher-report BASC-3 contains the above, in addition to a School Problems composite scale.
Timepoint [2] 333748 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [1] 418000 0
Child inhibitory attention and attention (direct measure of executive function) using the Flanker task within the NIH Toolbox suite of assessments, administered on an iPad. Children are required to focus on a target stimulus (i.e., a fish) while inhibiting attention to stimuli flanking it (“flankers”). Some trials present the target stimulus pointing in the same direction as the flankers (congruent), with other trials in the opposite direction (incongruent).
Timepoint [1] 418000 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [2] 418001 0
Set shifting (direct measure of executive function) using the Dimensional Change Card Sort task, within the NIH Toolbox suite of assessments, administered on an iPad. A visual target stimulus is presented, and the child must match this to one of two choice stimuli. On each trial, the child is instructed whether to match stimuli based on shape or colour both through a word presented on the screen, as well as orally through a voice recording.
Timepoint [2] 418001 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [3] 418133 0
Caregiver emotion regulation, as measured by the Difficulties in Emotional Regulation Scale (DERS; Gratz & Roemer, 2004). The DERS is a 36-item self-report measure of difficulties with emotion regulation. Items are rated on a five-point Likert-type scale which reflect the proportion of time an individual experiences a particular aspect of emotion regulation. The DERS provides a score for total difficulties with emotion regulation and six subscales (Non-Acceptance of Emotional Responses, Difficulty Engaging in Goal Directed Behaviour, Impulse Control Difficulties, Lack of Emotional Awareness, Limited Access to Emotion Regulation Strategies, and Lack of Emotional Clarity), with higher scores indicative of greater difficulties with emotion regulation.
Timepoint [3] 418133 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [4] 418134 0
Caregiver psychological wellbeing, as measured by the Depression Anxiety Stress Scales (DASS) (Lovibond & Lovibond, 1995). The DASS-21 is a 21-item assessment tool that consists of three, 14-item scales measuring depression, anxiety, and stress.
Timepoint [4] 418134 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [5] 418135 0
Child heart-rate variability, as a physiological measure of emotional regulation. The data collection process involves placing two recording electrodes that have a slightly sticky adhesive to the skin (less adhesive than a typical band-aid). These can be placed by the caregiver or researcher or the child themselves just below their neckline. Recording will commence with a baseline period where the participating caregiver and child watch a neutral video (Spot the Dog). The caregiver and child then undertake a task where they engage in a brief period of play (jigsaw or etcher sketch depending on child's age).
Timepoint [5] 418135 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [6] 418136 0
Caregiver heart-rate variability, as a physiological measure of emotional regulation. The data collection process involves placing two recording electrodes that have a slightly sticky adhesive to the skin (less adhesive than a typical band-aid). These can be placed by the caregiver or researcher just below their neckline. Recording will commence with a baseline period where the caregiver and participating child watch a neutral video (Spot the Dog). The caregiver and child then undertake a task where they engage in a brief period of play (jigsaw or etcher sketch depending on child's age).
Timepoint [6] 418136 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [7] 418705 0
Quality of parent/carer-child caregiving as measured by the Emotional Availability Scales (EA Scales) (Biringen, 2008). Emotional availability is a multidimensional construct for understanding emotional relationships within a dyadic structure. The EA Scales allow for assessment in varied settings and cultures by the coding of a 10 to 20-minute filmed interaction between the parent and child. The scales assess six dimensions of emotional availability (EA) in the relationship: four for the adult (sensitivity, structuring, non-intrusiveness and non-hostility) and two for the child (responsiveness to adult and involvement with adult).
Timepoint [7] 418705 0
Baseline, post-intervention (within 2 weeks of intervention completion), 6-months post-intervention (primary timepoint), 12-months post-intervention
Secondary outcome [8] 418706 0
Utility of the intervention models as measured by comprehensive implementation data collected for both intervention arms throughout implementation. The data collected aims to facilitate a cost-benefit analysis, following the approach taken by Barlow et al., 2019 (e.g., resources required to implement each intervention including staffing, time, and materials).
Timepoint [8] 418706 0
Throughout implementation and evaluation period
Secondary outcome [9] 418707 0
Utility of the intervention models as measured by short semi-structured qualitative interviews with the practitioners implementing the interventions and a random sample of families from the study. These interviews will focus on ascertaining barriers and facilitators to implementation and gaining an understanding of what was helpful and/or not helpful for each intervention model. These interviews will be voice-recorded and transcribed for analysis.
Timepoint [9] 418707 0
Within one-month of intervention completion

Eligibility
Key inclusion criteria
Children who have been assessed and received either a diagnosis of FASD with or without 3 sentinel facial features or an 'At Risk' designation within 18-months prior to referral will be eligible for the trial. This will be based on the Australian Guide to FASD.

Children must be enrolled in preparatory to Grade 3 at school and/or must reach age 5 years by June 30 of enrolling year through to maximum age 8.5 years. Children may be residing with a biological parent, kinship carer, foster carer, or carer designated by a governmental authority (e.g., Child Safety). Families must reside within 80 kilometres of Griffith University Logan campus to be eligible for recruitment. If literacy is an issue, measures and forms can be read to potential participants.

At least one caregiver per child is required to participate. Caregiver(s) must be aged 18 years and over, with no limits on the upper age range. Caregivers may be biological parents, kinship carers, foster carers, adoptive parents, or any other caregiver designated by governmental entities (e.g., Child Protection authorities).
Minimum age
54 Months
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children and/or caregivers will be ineligible for the trial if: (1) Either the child or participating caregiver have been diagnosed with Intellectual Disability as per the Diagnostic and Statistical Manual of Mental Disorders (DSM-5 or DSM-5-TR) or ICD-10/11 (Severe or Profound) will be ineligible for the trial; (2) Either the child or participating caregiver has insufficient fluency in English for conversational use; or (3) Either the child or family have previously participated in the Parents under Pressure or Alert® program or are currently receiving either of these interventions.

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)
Central randomisation by computer, conducted by researcher not involved in directly implementing the trial interventions.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The trial will use dynamic (adaptive) random allocation using a variation of a cohort multiple randomised trial design (cmRCT). This design relies on the use of cohorts of eligible participants to efficiently align randomised trials to routine practice. In practice, a cohort of individuals are randomly assigned prior to seeking informed consent and are then approached with an offer to participate in their assigned intervention. Participants are not made aware of alternative interventions until completion of their participation. This design has been chosen over simple randomisation for the following reasons. First, it will permit recruitment of eligible participants from recent cohorts of children diagnosed with FASD under the auspices of a related research projects. Second, the design will allow for careful control of the flow of participants so that they are not left waiting for their assigned intervention, which may increase the likelihood of attrition and lowering of statistical power. Third, the cmRCT design reduces the likelihood of differential refusal, which can introduce bias and reduce statistical power. Fourth, drawing on the existing cohorts of participants will allow the trial to begin earlier, and additional participants can be drawn at a later time-points from a growing cohort of participants currently being assessed for a connected diagnostic study.

In practice, 8-12 eligible children from an already existing eligible cohort will be allocated via computer software using block randomisation to either the PuP or Alert® arm of the trial. Families will be approached to seek consent to participate in their assigned treatment. Close to the completion of each Alert® group, the next cohort of eligible families will be allocated via block randomisation to either the PuP or Alert® arm of the trial. Cohorts of eligible participants must be a minimum of 8-12 children to accommodate attrition and still retain at least 3 children Alert® group.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study aims to recruit 80 families, which will form 6 – 8 smaller cohorts. This sample size is in line or larger than other intervention studies conducted with children who have a diagnosis of FASD (see Betts et al., 2022; 10.1002/cl2.1258). Further, the complexity of FASD requires smaller caseloads to maximise feasibility and treatment fidelity. Power analysis was informed by a trial of Alert® using a sample of 25 primary school children with a diagnosis of FASD (Nash et al., 2012; https://www.proquest.com/docview/1349625775?pq-origsite=gscholar&fromopenview=true). Using the BRIEF Global Executive Composite post-intervention mean (75.1) and standard deviation (9.7) for the Alert® group and the post-intervention mean for the non-treatment control group (83.0), with power set 90% and alpha level at 0.05 (2-tailed), a sample size of 64 would be required to detect differences between treatment groups.

An intent-to-treat analysis will be conducted on all scales provided by the standardised measures using multi-level modeling (MLM). Additional per-protocol analyses may also be conducted if there are significant deviations required from the trial protocol. Descriptive statistics will be provided for all measured variables (medians and ranges, means and variances, or contingency tables, depending on the variable distribution and type). Analysis of baseline data will be undertaken to verify comparability between the two treatment conditions and any significant differences will be accounted for in subsequent modeling.

Subsidiary analyses will include an examination of change between groups over time, moderators of change within and between treatment groups, and potential mechanisms of change. These analyses will be conducted using MLM approaches (e.g., cross-lagged modelling, latent growth curve modelling), informed by the nature of the final data. A priori moderators will be informed by the approach taken in Dawe et al. (2022; doi:10.1111/add.15579). Mechanism of change analyses will test whether child outcomes are mediated by improvements in parental emotional regulation and the quality of the caregiving relationship. Multiple imputation (MI) will be used to compensate for missing data at different assessment points.

Qualitative data will be fully transcribed and analysed thematically using NVivo 8.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
20/03/2023
Actual
Date of last participant enrolment
Anticipated
31/10/2024
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 312853 0
Government body
Name [1] 312853 0
Australian Department of Health as part of the Alcohol, Tobacco and Other Drugs program: Fetal Alcohol Spectrum Disorder (FASD) Diagnostic Services and Models of Care Grant Opportunity (4-G041V23)
Country [1] 312853 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
176 Messines Ridge Rd
Mount Gravatt
Queensland
4122
Country
Australia
Secondary sponsor category [1] 314502 0
None
Name [1] 314502 0
Address [1] 314502 0
Country [1] 314502 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312130 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 312130 0
Ethics committee country [1] 312130 0
Australia
Date submitted for ethics approval [1] 312130 0
14/04/2022
Approval date [1] 312130 0
18/05/2022
Ethics approval number [1] 312130 0
2022/283
Ethics committee name [2] 312347 0
Department of Children, Youth Justice and Multicultural Affairs, Research and Evaluation
Ethics committee address [2] 312347 0
Ethics committee country [2] 312347 0
Australia
Date submitted for ethics approval [2] 312347 0
30/05/2022
Approval date [2] 312347 0
28/11/2022
Ethics approval number [2] 312347 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123586 0
Prof Sharon Dawe
Address 123586 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Queensland
4122
Country 123586 0
Australia
Phone 123586 0
+61 0419910968
Fax 123586 0
Email 123586 0
[email protected]
Contact person for public queries
Name 123587 0
Sharon Dawe
Address 123587 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Queensland
4122
Country 123587 0
Australia
Phone 123587 0
+61 0419910968
Fax 123587 0
Email 123587 0
[email protected]
Contact person for scientific queries
Name 123588 0
Sharon Dawe
Address 123588 0
School of Applied Psychology
Griffith University
176 Messines Ridge Road
Mount Gravatt
Queensland
4122
Country 123588 0
Australia
Phone 123588 0
+61 0419910968
Fax 123588 0
Email 123588 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Ethical approvals does not allow for sharing of individual participant data due to the risk of families being identifiable.


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.