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Trial registered on ANZCTR


Registration number
ACTRN12618001866291
Ethics application status
Approved
Date submitted
13/11/2018
Date registered
16/11/2018
Date last updated
27/11/2024
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
ParentWorks Spectrum: A parenting intervention for young children with autism
Scientific title
ParentWorks Spectrum: A pilot randomised controlled trial of a brief integrated parent mediated intervention for young children with autism
Secondary ID [1] 296542 0
None
Universal Trial Number (UTN)
U1111-1223-3755
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Autism Spectrum Disorder 310323 0
Behavioral Disorders 310339 0
Condition category
Condition code
Mental Health 309071 309071 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants of ParentWorks Spectrum are children diagnosed with autism aged between 2 and 5 years of age and their parents referred to the Sydney Child behaviour Research Clinic who report clinically significant levels of behavioural and/or parenting difficulties.
The aim of this study is to establish the feasibility for a brief, cost effective, integrated intervention for parents of young children with autism, incorporating current evidence-based treatments and empirical knowledge of both child and family functioning. This study seeks to determine the effectiveness and acceptability of an integrated parent mediated intervention in improving:
1) Child Behavioural difficulties
2) Child core social and communicative symptoms
3) Parenting practices and parental well-being
Participants who meet inclusion criteria are invited to attend an initial assessment session. Following this assessment session, participants will then be randomly allocated to the parenting intervention group or to the waitlist control group.
Participants allocated to the parenting intervention group will be invited to attend 11 (60-90 minute) 1:1 weekly sessions with a trained clinician (registered psychologist with a minimum of 6 years training) immediately following the initial assessment. Participants allocated to the waitlist control group will be invited to attend 11 (60-90 minute) 1:1 weekly sessions with a trained clinician (registered psychologist with a minimum of 6 years training) three months following the date of the initial assessment.
The 12 treatment sessions are divided into three (four session) modules:
1) Managing maladaptive behaviours
2) Enhancing parent-child interactions
3) Enhancing parental teamwork, parenting practices and self-care.
Throughout treatment, clinicians work collaboratively with parents to deliver intervention strategies that target child behavioural difficulties, parent-child interactions in addition to parenting difficulties experienced in the context of parenting a child with autism. Session content has been informed by current evidence-based treatments, scientific reviews of relevant scientific literature and the CI’s experience in child behaviour research and clinical work with families.
Strategies will be taught to parents through active skills training and will involve role-plays, modelling, rehearsing and feedback.
Intervention code [1] 312845 0
Behaviour
Comparator / control treatment
30 children diagnosed with ASD and their parents will comprise the wait-list control group. The wait-list control group will receive the parenting intervention 12 weeks after the completion of the initial assessment.
Control group
Active

Outcomes
Primary outcome [1] 308040 0
The severity of autism symptoms assessed with the Social Responsiveness Scale (SRS; Constantino & Gruber, 2012).
Timepoint [1] 308040 0
The SRS will be administered at baseline and post-assessment (12 weeks post-baseline).
Primary outcome [2] 308041 0
Child Externalising behaviours will be assessed with the Eyberg Child Behaviour Inventory (ECBI; Eyberg & Pincus, 1999).
Timepoint [2] 308041 0
The ECBI will be administered at baseline and post-assessment (12 weeks post-baseline).
Primary outcome [3] 308042 0
Parental Stress Index Fourth Edition Short Form (PSI-SF; Abidin, 1990) will be used to assess parental stress associated with parenting.
Timepoint [3] 308042 0
The PSI-SF will be administered at baseline and post-assessment (12 weeks post-baseline).
Secondary outcome [1] 353823 0
Parenting practices will be assessed with the Parenting Scale (PS; Arnold, O'leary, Wolff, & Acker, 1993; Rhoades & O'Leary, 2007). This is a composite measure examining parental over-reactivity (e.g., authoritarian, irritable), laxness (e.g., permissive, inconsistent) and hostility (e.g., harsh physical and verbal discipline).
.
Timepoint [1] 353823 0
The PS will be administered at baseline and post-assessment (12 weeks post-baseline).
Secondary outcome [2] 353824 0
Parents’ sense of competence as a parent will be assessed with the Parenting Sense of Competency scale (PSOC; Johnston & Mash, 1989).
Timepoint [2] 353824 0
The PSOC will be administered at baseline and post-assessment (12 weeks post-baseline).
Secondary outcome [3] 353825 0
Child Emotional symptoms will be assessed with the Strengths and Difficulties Questionnaire (SDQ; Goodman, 2001). This is a composite measure examining child conduct problems; hyperactivity/inattention; peer relationship problems; and pro-social behaviour.
Timepoint [3] 353825 0
The SDQ will be administered at baseline and post-assessment (12 weeks post -baseline).
Secondary outcome [4] 353826 0
Inter-parental conflict/team work between parents who operate as parenting teams will be assessed using the Parent Problem Checklist (PPC; Dadds & Powell, 1991).
Timepoint [4] 353826 0
The PPC will be administered at baseline and post-assessment (12 weeks post -baseline).
Secondary outcome [5] 353827 0
Parenting practices (responsiveness and directive parenting), parents’ implementation of treatment strategies and child social communication skills will be assessed through observation. Parent-child interactions will be coded using the Behavioural Observation Coding System: Family Observation Schedule (5th edition; Hawes et al., 2013) that has been specifically adapted for this study.
Timepoint [5] 353827 0
Family observations will be conducted at baseline and post treatment.
Secondary outcome [6] 353829 0
Acceptability of the intervention will be assessed through recording parental attendance at sessions and rates of retention at the conclusion of the intervention, parental adherence and engagement during sessions (assessed trough the completion of homework tasks).
Timepoint [6] 353829 0
Acceptability and feasibility will be examined on a weekly basis until intervention completion and three months post treatment.
Secondary outcome [7] 353980 0
Parental satisfaction with the intervention will be examined using the Parent Satisfaction Rating Scale (PSRS) (Charlop-Christy & Carpenter, 2000).
Timepoint [7] 353980 0
The PSRS will be administered post treatment.
Secondary outcome [8] 407197 0
Diagnostic Interview Schedule for Children, Adolescents and Parents- DISCAP (Tissue, Hawes, Lechowicz, & Dadds, 2022). The DISCAP is a reliable diagnostic system administered by a clinical psychologist 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.
Timepoint [8] 407197 0
The DISCAP will be administered baseline and post-assessment (12 weeks post -baseline).

Eligibility
Key inclusion criteria
Participants will be children aged 2 to 5 years 11 months with a confirmed diagnosis of autism at baseline and their parents. Parents must be able to attend 12 consecutive weekly sessions. Fluency in English will also be a criterion for inclusion due to the language format of the psychological measures
Minimum age
2 Years
Maximum age
6 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child exclusionary criteria include severe comorbid developmental delay (DQ< 35), significant vision, hearing or motor impairment, or a major medical disorder (e.g., cerebral palsy) that impacts the parent’s ability to attend weekly sessions or child involvement in the program or family involvement in engaged in current legal issues including child custody disputes, or current participation 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)
Participants will be randomly allocated to conditions using the balanced blocked randomisation method. Participants will be randomly allocated to either PI+TAU (A) or WL+TAU (B) in blocks of six (10 blocks in total for 60 participants). Block numbers will be concealed in individual sealed opaque envelopes which will be shuffled and opened in a random order to prevent researches being able to predict group allocations.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The minimum total sample size required for this research is N=35 families. This value is based upon a power analysis (G Power version 3.0.1) indicating that N=27 families is sufficient to detect a medium effect size (d=0.5). Statistical analysis will involve multivariate analyses in addition to mediational and moderational analyses.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
7/01/2019
Actual
19/09/2019
Date of last participant enrolment
Anticipated
20/12/2020
Actual
21/12/2020
Date of last data collection
Anticipated
20/03/2021
Actual
20/09/2021
Sample size
Target
30
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 24659 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 301122 0
University
Name [1] 301122 0
The University of Sydney
Country [1] 301122 0
Australia
Funding source category [2] 304272 0
Charities/Societies/Foundations
Name [2] 304272 0
Australian Rotary Health
Country [2] 304272 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Camperdown NSW 2006
Country
Australia
Secondary sponsor category [1] 300740 0
None
Name [1] 300740 0
Address [1] 300740 0
Country [1] 300740 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301874 0
The University of Sydney Human Research Ethics Committee (HREC)
Ethics committee address [1] 301874 0
Ethics committee country [1] 301874 0
Australia
Date submitted for ethics approval [1] 301874 0
20/08/2018
Approval date [1] 301874 0
10/10/2018
Ethics approval number [1] 301874 0
USYD HREC 2018/716

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

Contacts
Principal investigator
Name 88394 0
Prof Mark Dadds
Address 88394 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 88394 0
Australia
Phone 88394 0
+61 2 9114 4326
Fax 88394 0
Email 88394 0
mark.dadds@sydney.edu.au
Contact person for public queries
Name 88395 0
Bridie Leonard
Address 88395 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 88395 0
Australia
Phone 88395 0
+61 2 9114 4326
Fax 88395 0
Email 88395 0
bridie.leonard@sydney.edu.au
Contact person for scientific queries
Name 88396 0
Mark Dadds
Address 88396 0
The University of Sydney Child Behaviour Research Clinic
Level 1, 97 Church Street Camperdown NSW 2050
Country 88396 0
Australia
Phone 88396 0
+61 2 9114 4326
Fax 88396 0
Email 88396 0
mark.dadds@sydney.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.