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Trial registered on ANZCTR


Registration number
ACTRN12614000973617
Ethics application status
Approved
Date submitted
2/09/2014
Date registered
10/09/2014
Date last updated
10/09/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
A play-based intervention to improve the social play skills of children with Attention Deficit Hyperactivity Disorder (ADHD)
Scientific title
The effect of a play-based intervention on social play skills of children with Attention Deficit Hyperactivity Disorder.
Secondary ID [1] 285277 0
Nil known
Universal Trial Number (UTN)
U1111-1161-0904
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Social difficulties 292935 0
Attention Deficit Hyperactivity Disorder (ADHD) 292936 0
Condition category
Condition code
Mental Health 293231 293231 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children will receive a 10-week play-based intervention called 'The Ultimate Guide to Making Friends'. After attending a baseline assessment, children and their invited typically-developing playmate will attend the intervention which involves 6 weekly clinic sessions led by an occupational therapist (weeks: 1, 2, 3, 5, 7, 10). All clinic sessions will last 1 hour and involve a video-feedback discussion and clinic play session with the therapist. The child and their playmate will first view video footage of themselves playing from the previous week. The footage will have explicit short clips of footage where the children played well together and where they were not engaged in cooperative play. Children will be helped by the therapist to discuss the footage and brain storm three 'green skills' while they play in the playroom together (e.g., share toys, play my friend's game, talk to fix problems). The therapist and children then went into the playroom where the therapist modelled desired social skills while playing with the children and facilitated cooperative play between them.

During weeks 4, 6, 8 & 9 children with ADHD will complete home activity facilitated by their parents which includes a DVD and manual resource and weekly play-date with the playmate they invited to the study. Parents will first read the prescribed manual chapter - each containing information about a social skill (e.g., perspective-taking) (15 minutes) before watching the correlating DVD episode involving fictional characters with their child (30 minutes). The DVD will cue parents when to pause the episode and have a discussion with their child about what they just watched. The DVD was designed to give children ideas about play with friends and how to repair social interactions when a problem occurred. During the week parents also invited the playmate from the study over for a 40 minute play-date. Before the playmate arrived parents where encouraged to talk with their child and come up with three things to remember while they played with their friend (based on what they watched from the DVD episode).

Parent-reported treatment adherence was recorded by therapists on a weekly basis across the following categories: clinic sessions, DVD and manual activity and play-date.

A post-test measurement will be taken in the week 10 clinic session. A 1 hour follow-up will then be conducted at the home of children with ADHD one month after the intervention. This involves a video-taped session of the child and their playmate playing in the home environment and a semi-structured interview completed by parents.
Intervention code [1] 290163 0
Behaviour
Comparator / control treatment
After all children with ADHD complete a blinded baseline assessment they be randomly allocated in pairs to an 1) intervention (immediate start) or 2) no-treatment 10-week waitlist/control group.

After the 10-week wait period, children will commence the intervention.
Control group
Active

Outcomes
Primary outcome [1] 293084 0
To investigate if the social play skills of children with ADHD change following the intervention (As measured by the Test of Playfulness, ToP; Bundy, 2004)
Timepoint [1] 293084 0
Pre- to post-intervention (10 weeks) and from pre-intervention to the 1-month home follow-up
Primary outcome [2] 293085 0
To investigate if the pragmatic language abilities of children with ADHD change following the intervention (As measured by the Pragmatics Observational Measure, POM; Cordier et al. 2014)
Timepoint [2] 293085 0
Pre - to post-intervention (10 weeks) and from pre- intervention to the 1-month home follow-up
Secondary outcome [1] 310306 0
To investigate if children with ADHD demonstrate changes in their pragmatic (social use of) language skills as scored by parents using the Children's Communication Checklist 2nd edition; subscales 1) use of context, 2) nonverbal communication, 3) social relations and 4) interests (CCC-2; Bishop 2003).
Timepoint [1] 310306 0
Pre- to post-intervention
Secondary outcome [2] 310307 0
To investigate changes in the social play (ToP) and pragmatic language skills (POM) of typically-developing playmates of children with ADHD following the intervention
Timepoint [2] 310307 0
Pre- to post-intervention (10 weeks) and pre-intervention to the 1-month home follow-up

Eligibility
Key inclusion criteria
Children with ADHD: had to have a formal diagnosis of ADHD (made by a paediatrician or psychiatrist using recognised diagnostic procedures e.g. DSM-IV). Children continued prescribed medication for ADHD. Parents were asked not to change their child's medication during the study. One parent/primary caregiver also needed to available to participate in the intervention delivery.

Typically-Developing Playmates: did not have a diagnosis of ADHD and no concerns were raised by parents or teachers about the children’s development.

The Conners Comprehensive Behavior Rating Scales (CCBRS; Conners, 2008) was used as a screening measure to confirm the presence or absence of ADHD symptoms. Children with ADHD needed to score above the clinical cut off (T-Score >70) and playmates needed to score below the borderline clinical cut off (T-score <65).
Minimum age
5 Years
Maximum age
12 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The study commenced at the time of the DSM-IV. Children with ADHD were excluded if they were diagnosed with other major neurodevelopmental or psychiatric disorders (e.g. intellectual disability)as well as ADHD.

Playmates were excluded if they scored above the clinical cut off on the CCBRS.

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)
Before recruitment commenced, an even number of opaque envelopes were prepared and sealed containing a piece of paper with either 'group 1 intervention' or 'group 2 10-week wait'.

When interested parents phoned the researcher about the study, a baseline assessment was scheduled. Information collected over the phone included the parents/child's name and date/time of the initial baseline assessment (where researchers and participants were blinded to group allocation).
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A pairwise randomisation method was used. Once two parents had booked in a baseline assessment, a sealed envelope from each pile (group 1 or group 2) was taken to a staff member not involved in the research. A piece of paper containing the two date/times of the baseline assessments was also taken to the staff member. The staff member was asked to use simple randomisation procedures e.g. coin toss to pick one of the two dates/times written on the paper. They were then instructed to shuffle the two envelopes and place this time on one of the sealed envelopes. The researcher left the room while the staff member completed the procedure.

The envelopes were then placed in a client folder which was taken by researcher into the baseline assessment. At the end of the baseline assessment, the researcher handed the parent the sealed envelope from the client folder (participants and the research/therapist were only blinded for the baseline assessment).
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
Based on 3 previous pilot studies and power/sample size calculations, we determined the sample size needed was 15 children with ADHD per group.

To calculate sample size we used the G Power calculator and input the: 1) desired power (e.g., 0.8), 2) statistical test (e.g., ANOVA), 3) alpha value (0.05) and 4) expected effect (>.5 large); which generated the minimum sample needed n = 30.

Anticipated statistical analysis includes: One-way repeated measures ANOVA with post-hoc LSD and Cohen's'-d effect sizes to determine the efficacy of the intervention, and Stepwise linear regression model analysis to determine variables that predict intervention change.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2013
Actual
1/06/2013
Date of last participant enrolment
Anticipated
29/03/2014
Actual
7/06/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 8659 0
2141 - Lidcombe

Funding & Sponsors
Funding source category [1] 289897 0
Charities/Societies/Foundations
Name [1] 289897 0
The Rotary Club of Mosman
Country [1] 289897 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
75 East St
Lidcombe
NSW
Australia
2141
Country
Australia
Secondary sponsor category [1] 288583 0
None
Name [1] 288583 0
Address [1] 288583 0
Country [1] 288583 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291619 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291619 0
Ethics committee country [1] 291619 0
Australia
Date submitted for ethics approval [1] 291619 0
29/11/2012
Approval date [1] 291619 0
21/03/2013
Ethics approval number [1] 291619 0
2013/109

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 172 172 0 0
/AnzctrAttachments/367030-Appendix G Intervention structure.doc

Contacts
Principal investigator
Name 51178 0
Ms Sarah Wilkes-Gillan
Address 51178 0
The University of Sydney, Faculty of Health Sciences,
75 East St
Lidcombe
NSW
Australia
2141
Country 51178 0
Australia
Phone 51178 0
+61 402402359
Fax 51178 0
Email 51178 0
swil8454@uni.sydney.edu.au
Contact person for public queries
Name 51179 0
Sarah Wilkes-Gillan (PhD Candidate)
Address 51179 0
The University of Sydney, Faculty of Health Sciences,
75 East St Lidcombe
NSW
Australia
2141
Country 51179 0
Australia
Phone 51179 0
+61 402402359
Fax 51179 0
Email 51179 0
swil8454@uni.sydney.edu.au
Contact person for scientific queries
Name 51180 0
Sarah Wilkes-Gillan
Address 51180 0
The University of Sydney, Faculty of Health Sciences,
75 East St Lidcombe
NSW
Australia
2141
Country 51180 0
Australia
Phone 51180 0
+61 402402359
Fax 51180 0
Email 51180 0
swil8454@uni.sydney.edu.au

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
EmbaseA randomised controlled trial of a play-based intervention to improve the social play skills of children with attention deficit hyperactivity disorder (ADHD).2016https://dx.doi.org/10.1371/journal.pone.0160558
N.B. These documents automatically identified may not have been verified by the study sponsor.