Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12621000596808
Ethics application status
Approved
Date submitted
11/03/2021
Date registered
19/05/2021
Date last updated
7/04/2024
Date data sharing statement initially provided
19/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
ParentWorks Spectrum: An integrated parenting intervention for children with autism.
Scientific title
Evaluation of the efficacy of ParentWorks Spectrum, an integrated parenting intervention for children with Autism Spectrum Disorder targeting child externalising behaviours, social-communication and adaptive functioning skills, and parenting practices.
Secondary ID [1] 303052 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 320132 0
Behavioral Disorders 320133 0
Condition category
Condition code
Mental Health 318074 318074 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants are parents of children diagnosed with autism aged between 2 and 5 years 11 months of age who are referred (or self-refer) to the Sydney Child behaviour Research Clinic, and would like assistance managing child disruptive behaviour.

Participants randomly allocated to the ParentWorks Spectrum will receive 12 (one hour) 1:1 weekly sessions with a trained clinician. The intervention follows a structured treatment manual and the components of this intervention have been developed from current evidence-based treatments to address child externalising behaviours (Module 1; sessions 1-4); parent-child reciprocity and child social-communication skills (Module 2; sessions 5-9); and parental wellbeing (Module 3; sessions 10-12). While the treatment is 12 sessions in duration, up to 15 sessions can be provided in order to provide additional time for the content to be delivered where needed.

The assessment and intervention will be delivered online via the platform Zoom. Throughout treatment, clinicians work collaboratively with parents to deliver intervention strategies that target child behavioural difficulties, parent-child interactions, in addition to parental stress and parenting difficulties experienced in the context of parenting a child with autism.
Strategies will be taught to parents through active skills training and will involve role-plays, modelling, rehearsing and feedback.

This intervention will be delivered by utilising the manual, ParentWorks Spectrum: A parent mediated intervention for young children with autism (Leonard, Hawes, Tully, Eapen & Dadds, 2019).
Clinician adherence to treatment content and manual will be monitored using weekly clinician checklists that are developed specifically for this study. Furthermore, session attendance, parental engagement in session, and parent homework completion will be measured to monitor engagement to treatment.
Intervention code [1] 319349 0
Behaviour
Comparator / control treatment
Parents randomly allocated to the waitlist control group will wait for 12 weeks before receiving the ParentWorks Spectrum parenting intervention. The waitlist group will continue to receive treatment as usual, as long as this does not involve a parenting program.

Treatment as usual can encompass a range of treatments and services that parents may seek for their child, including but not limited to: occupational therapy, speech therapy, physical therapy (e.g., physiotherapy), mental health services (e.g., psychology, psychiatry), dietician/naturopath/nutritionist services, and Early Intensive Behavioural Interventions. Additionally, parents may have interactions with their child’s primary care team including but not limited to their GP, Paediatrician, Psychiatrist etc.
Control group
Active

Outcomes
Primary outcome [1] 326062 0
Child diagnostic profiles will be assessed using the Diagnostic Interview Schedule for Children, Adolescents and Parents– DISCAP (Johnson, Barrett, Dadds, Fox, and Shortt, 1999). The DISCAP is a reliable diagnostic system administered by a psychologist to parents in order to make DSM-5 diagnoses, and will be used to conduct a comprehensive diagnostic profile for each child. Blind checks will be used to examine the reliabilities using a secondary team of psychologists to check the diagnosis made by the primary clinician. This diagnostic system is a reliable indicator of externalizing and internalizing disorders and provides clinicians with a severity rating. A composite variable of severity of externalising behaviours (Oppositional Defiant Disorder (ODD) and/or Conduct Disorder (CD)) specifically will be the primary outcome for this study. ODD and CD diagnoses will be used as an indicator of externalising behavioural issues collapsed into the one composite primary outcome—the child’s diagnostic profile. The DISCAP will be completed by the treating clinician (at baseline) and by a blind clinician (blind to intervention group and pre-treatment diagnosis and severity) at intervention completion and three month follow-up.
Timepoint [1] 326062 0
The DISCAP will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Primary outcome [2] 326149 0
Child Externalising behaviours will be assessed with the Intensity and Problem scales of the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [2] 326149 0
The primary outcomes on the ECBI will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Primary outcome [3] 326150 0
The severity of autism symptoms will be assessed with the total score and subscale scores (social awareness, social cognition, social communication, social motivation, restricted interests and repetitive behaviours) on the Social Responsiveness Scale (SRS; Constantino & Gruber, 2012), a parent-report measure completed by all participating parents (both mothers and fathers).
Timepoint [3] 326150 0
The SRS will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [1] 390248 0
Child emotional and behavioural symptoms will be assessed with the total score and subscale scores (emotional symptoms, conduct problems, hyperactivity-inattention, peer relationship problems, and prosocial behaviours) on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001), a parent-report questionnaire completed by all participating parents (both mothers and fathers).
Timepoint [1] 390248 0
The SDQ will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [2] 390249 0
Global functioning of the child will be assessed by the Children’s Global Assessment Scale (CGAS; Wagner et al., 2007). The CGAS will be rated by the treating clinician (at baseline) and a blind clinician (blind to intervention group and pre-treatment rating; at post-assessment and follow-up).
Timepoint [2] 390249 0
The CGAS will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [3] 390250 0
Child adaptive functioning will be assessed using the adaptive behaviour composite that consists of the communication, daily living skills, socialisation domains on the parent form of the Vineland-3 (Sparrow, Cicchetti, & Saulnier, 2016). This measure will be completed by the main caregiver only.
Timepoint [3] 390250 0
The Vineland-3 will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [4] 390251 0
Parents’ sense of competence will be assessed with the total and subscale scores (efficacy and satisfaction) on the Parenting Sense of Competency scale (PSOC; Johnston & Mash, 1989), completed by all participating parents (both mothers and fathers).
Timepoint [4] 390251 0
The PSOC will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [5] 390252 0
Parenting practices will be assessed with the total and subscale scores (overreactivity, laxness and hostility) from the Parenting Scale (PS; Arnold, O'leary, Wolff, & Acker, 1993; Rhoades & O'Leary, 2007). This measure is completed by all participating parents (both mothers and fathers).
Timepoint [5] 390252 0
The PS will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [6] 390253 0
A videotaped observation of parent-child interaction will be coded for parenting practices (responsiveness and positive parenting), and child social communication skills and disruptive behaviours. Parent-child interactions will be coded using the Behavioural Observation Coding System: Family Observation Schedule (FOS, 5th edition; Hawes et al., 2013) that has been specifically adapted for this study.
Timepoint [6] 390253 0
The videotaped observation of parent-child interaction will be conducted and coded at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only). Only the primary caregiver will participate in the videotaped observation.
Secondary outcome [7] 390254 0
Inter-parental conflict/team work between parents who operate as parenting teams will be assessed with the Problem scale on the Parent Problem Checklist (PPC; Dadds & Powell, 1991), a parent-completed measure completed by all participating parents (both mothers and fathers).
Timepoint [7] 390254 0
The PPC will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [8] 390255 0
Parental well-being will be assessed using the short version of the Depression Anxiety Stress Scales (DASS-21; Lovibond & Lovibond, 1995), a parent-completed measure completed by all participating parents (both mothers and fathers). The depression, anxiety and stress scales and total score will be used. The DASS subscale scores are not considered composite or separate outcomes. Instead, the subscales and total scores will be analysed together in a MANOVA as they are correlated and will not be analysed as separate variables. This applies to many of the secondary outcomes where questionnaires contain multiple subscales.
Timepoint [8] 390255 0
The DASS-21 will be administered at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [9] 390256 0
Teacher/educator report of child externalising behaviours will be assessed with the Intensity and Problem scales of the Sutter-Eyberg Student Behaviour Inventory (SESBI–R; Eyberg & Pincus, 1999).
Timepoint [9] 390256 0
The SESBI–R will be administered at baseline, post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).
Secondary outcome [10] 391165 0
Teacher report on child emotional and behavioural symptoms will be assessed with the total score and subscale scores (emotional symptoms, conduct problems, hyperactivity-inattention, peer relationship problems, and prosocial behaviours) on the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001).
Timepoint [10] 391165 0
Teacher report on the SDQ will be completed at baseline and post-assessment (12 weeks post-baseline; intervention, waitlist control), and three month follow-up (24 weeks post-baseline; intervention group only).

Eligibility
Key inclusion criteria
Inclusion criteria include: 1.Parents/caregivers of children aged 2 to 5 years 11 months with a diagnosis of autism at baseline; 2. Parents must be able to access high speed internet via computer or tablet (not smart phone) to participate in the intervention and attend weekly sessions (via Zoom) for 12 weeks; 3. Parents comfortable completing questionnaires and treatment sessions in English; 4. If child is receiving medication for behaviour, must be stable on current dose for 4 weeks, with no planned changes to medication regime; 5. Parents would like assistance in managing child disruptive behaviours.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Child exclusionary criteria are: 1. Severe comorbid developmental delay (DQ< 35) or significant vision, hearing or motor impairment; 2. Child has a major medical disorder (e.g., cerebral palsy) that impacts the parent’s ability to attend weekly sessions or child involvement in the program; 3. Family involvement in current legal issues including child custody disputes; 4. Severe parental mental health problems, domestic violence or substance use; 5. Family currently participating in another parenting intervention/research trial.

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 to treatment condition will be concealed to researchers using opaque sealed numbered envelopes.
Upon completion of the initial assessment with parents, participants will be randomised to either the parenting intervention (PI+TAU) or waitlist (WL+TAU) in an unrestricted (simple) randomisation, according to the sequentially numbered opaque sealed envelope (SNOSE) technique as specified by Doig and Simpson (2005). This will ensure random sequence allocation, masking of treatment allocation, and will provide an audit trail for confirming allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The sequencing for the random allocation will be determined using simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation).
Upon completion of the initial assessment with parents, participants will be randomised to either the parenting intervention (PI+TAU) or wait list (WL+TAU). Participants will be randomly allocated to either PI+TAU (A) or WL+TAU and allocation will be concealed in individual opaque envelopes as per the technique specified by Doig & Simpson (2005).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample size and power calculations for primary outcomes of reductions in child externalising behaviour and improvements in child social communication were calculated using G*Power. Effect size for primary outcomes was conservatively estimated based on the smallest effect size yet achieved across the pilot data for our interventions (f(V)=.25), those of Green et al. (2015) for the core symptoms interventions (f(V)=.29), and those of Bearrs et al. (2015) for reduction in externalising problems (f(V)=.45). Thus, to achieve statistical power = 0.8 for two primary outcome measures, each at p < 0.025, for 2 groups over 2 time points and a small effect size of f(V) = .25, we require a final sample of N = 160, or 80 in each group.
This research will also examine the synergistic relationship between changes in child behavioural difficulties (Module 1), child social and communication skills (Module 2) and parent wellbeing (Module 3), following the modules covering this content, for the Intervention group only. This will require the measurement of some outcomes during the intervention (ECBI, SRS, DASS, PPC) for the intervention group. However, these mid-treatment measures will not be used to examine the efficacy of the intervention. Regression analyses will be conducted to examine the relationship between the three aforementioned components and overall change from pre to post intervention.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
7/06/2021
Actual
6/08/2021
Date of last participant enrolment
Anticipated
31/07/2023
Actual
29/12/2023
Date of last data collection
Anticipated
25/06/2024
Actual
Sample size
Target
160
Accrual to date
Final
100
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment postcode(s) [1] 32451 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 307461 0
Government body
Name [1] 307461 0
NHMRC - National Health and Medical Research Council
Country [1] 307461 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
The University of Sydney, NSW 2006
Country
Australia
Secondary sponsor category [1] 308133 0
None
Name [1] 308133 0
Address [1] 308133 0
Country [1] 308133 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307538 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 307538 0
Ethics committee country [1] 307538 0
Australia
Date submitted for ethics approval [1] 307538 0
Approval date [1] 307538 0
22/12/2020
Ethics approval number [1] 307538 0
USYD HREC 2020/854

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

Contacts
Principal investigator
Name 107590 0
Prof Mark Dadds
Address 107590 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 107590 0
Australia
Phone 107590 0
+61 2 91144321
Fax 107590 0
Email 107590 0
[email protected]
Contact person for public queries
Name 107591 0
Bridie Leonard
Address 107591 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 107591 0
Australia
Phone 107591 0
+61 2 91144326
Fax 107591 0
Email 107591 0
[email protected]
Contact person for scientific queries
Name 107592 0
Mark Dadds
Address 107592 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 107592 0
Australia
Phone 107592 0
+61 2 91144326
Fax 107592 0
Email 107592 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


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.