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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
16/11/2018
Date data sharing statement initially provided
16/11/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Parenting on the Spectrum: A parenting intervention for children with autism
Scientific title
Parenting on the Spectrum: A parent mediated intervention for parents of children with autism targeting maladaptive behaviours, social-communication skills and parenting practices.
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 Parenting on the 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

Parents who meet inclusion criteria are invited to attend 12 (60-90 minute) 1:1 weekly sessions with a trained clinician (registered psychologist with a minimum of 6 years training). 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.

The 12 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.

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
Single group trial (pilot; no control group)
Control group
Uncontrolled

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 then weekly until intervention completion.
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 then weekly until intervention completion.
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 then weekly until intervention completion and 3 months post treatment.
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 then weekly until intervention completion and three months post treatment
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 then weekly until intervention completion and three months post treatment.
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, post treatment upon the completion of the intervention and three months post treatment.
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 then weekly until intervention completion and three months post treatment.
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.

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
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Child exclusionary criteria include presence of a known genetic disorder (e.g., fragile x), severe comorbid developmental delay (DQ< 35), significant vision, hearing or motor impairment, gestational age younger than 36 weeks, or a major medical disorder (e.g., cerebral palsy) that has significantly interfered with school/family life, or family involvement in engaged in current legal issues including child custody disputes.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
No allocation
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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
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
Address [1] 301122 0
Camperdown NSW 2006
Country [1] 301122 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
The University of Sydney
NSW 2006
Australia
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
This aim of this study is to establish the feasibility and preliminary efficacy for a brief parent mediated intervention for parents of children with autism aged between 2-6 years of age. The purpose of this research is to determine the effectiveness and acceptability of an integrated treatment approach that aims to improve maladaptive behaviours and core social communication symptoms in children with autism and parenting, parent-child interactions and parental well-being for their parents.

It is hypothesised that this intervention will be acceptable to parents and effective in reducing child externalising behaviours, improving the quality of parent-child interactions and parenting practices.
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
Ms 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
bleo3225@uni.sydney.edu.au
Contact person for scientific queries
Name 88396 0
Prof 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 other documents available
Summary results
No Results