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Trial registered on ANZCTR


Registration number
ACTRN12621001314819
Ethics application status
Approved
Date submitted
21/07/2021
Date registered
27/09/2021
Date last updated
27/09/2021
Date data sharing statement initially provided
27/09/2021
Type of registration
Retrospectively registered

Titles & IDs
Public title
A Comparison of Two Treatments: Collaborative and Proactive Solutions and Parent Management Training for Disruptive Behaviours in Youth delivered in a Community-Based Setting.
Scientific title
Effect of Community-Delivered Collaborative and Proactive Solutions and Parent Management Training on Youth with Oppositional Defiant Disorder: A Randomized Trial
Secondary ID [1] 304582 0
Nil known
Universal Trial Number (UTN)
U1111-1267-0105
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oppositional Defiant Disorder 322481 0
Behaviour disorders 322482 0
Condition category
Condition code
Mental Health 320118 320118 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Two active treatments are compared: Collaborative and Proactive Solutions (CPS) vs Parent Management Training (PMT) for the treatment of oppositional defiant disorder in youth.

160 youth, aged 7-14 years were randomised to one of the active conditions.

Treatments were delivered face-to-face up to 16 x 1 hour sessions, once a week for 16 weeks. Treatment was delivered to individual families only. Both parent/s and child attended each session. Treatment was delivered in a urban community-based psychology clinic. Following treatment families were offered 5 monthly booster sessions by phone to consolidate sessions. In these booster sessions parents reported how they were progressing and troubleshot any behaviour problems. The therapist then advised how to use previously taught skills in these situations. Phone calls ranged from 2-15 minutes. Families were advised of the option to access boosters, but they were optional.

Collaborative and Proactive Solutions is a cognitive behavioural model developed by Dr Ross Greene. The CPS model posits that challenging behaviours occur when a child's skills do not match the demands of the given situation eg., flexibility, transitioning, maintaining focus. CPS treatment focuses on helping parents identify their child’s lagging skills and reframe their perception of their child’s behavior using this conceptualization (Greene, 1998). From there, the parent(s) and young person identify current “unsolved problems” and are coached in steps to solve the problems collaboratively and proactively. CPS entails four treatment modules (a) psychoeducation and identification of unsolved problems, which explains the conceptualization of CPS and identifies the unsolved problems precipitating challenging behavior; (b) prioritizing unsolved problems based on their relationship to safety, gravity, or frequency; (c) learning about Plan A, B, and C and the concept that parents have a choice of how to respond to an unsolved problem; and (d) clinician modeling and coaching the use of Plan B to help parents and children solve problems together proactively. Plan A is parents responding to challenging behaviors in a unilateral manner. Plan B is parent and child collaborating to come up with a solution for the problem that preempts the challenging behaviour, and Plan C is putting aside expectations they have of the child to meet certain expectations. The CPS materials can be accessed via Dr Ross Greene. They can not be accessed from any other organisation.

Supplementary handouts were provided at the majority of sessions. They were already created and not created specifically for this study. Handouts for PMT are available in Barkeley's Defiant Child Manual. Handouts for CPS are readily available at: https://livesinthebalance.org/our-solution/#our-solution-overview

Treatment was delivered by experienced clinical psychologists (5 year plus experience) and graduate interns from a masters of Clinical Psychology program.

Training for therapists in both CPS and PMT conditions consisted of a one-day workshop, reading the manuals, listening to audiotapes of the entire course of treatment for 3 previous clients (approximately 40 hours), and 1-2 hours of weekly clinical supervision (dosage was matched for PMT and CPS).

Adherence to the allocated therapeutic model was assessed by having an independent rater, experienced in both therapies, code random audiotaped therapy sessions using the Session Content Analysis checklist (Ollendick et al., 2016). Independent raters, masked to the treatment being delivered, listened to an audio recording of a therapy session and then rated the presence or absence of treatment components on a 6-item scale. Each therapist also attended regular clinical supervision.
Intervention code [1] 320934 0
Treatment: Other
Intervention code [2] 320935 0
Behaviour
Comparator / control treatment
In this trial, Parent Management Training was utilised as an active control. We compared the effectiveness of an established treatment Parent Management Training (PMT) against an innovative treatment Collaborative and Proactive Solutions (CPS) for the treatment of oppositional defiant disorder in youth aged 7-14 years.

The PMT condition used a manualized program, Defiant Child (2nd ed., Barkley, 1997), which ordinarily comprises ten weekly 1-hour group sessions. PMT is a well-established, evidence-based therapy for targeting behavior problems based on behavioral and social learning principles (Barkley, 1997). The PMT program used in this study, modeled after that of Ollendick and colleagues (2016), was conducted with individual families with both parent and child present in parts of each session. The additions necessitated an extended timeframe (and can be accessed from Dr Rachael Murrihy). Barkley’s program comprised a number of core components, including (a) education regarding multifactorial causes of problem behaviors; (b) developing “positive attending” skills; (c) utilizing differential attending to increase compliance; (d) giving effective commands, (e) implementing home reward systems; (f) instruction in "time out" and response cost; and (g) use of a contingency system.

A combination of experienced clinical psychologists employed by the centre (5 plus years experience) and intern graduates from a Masters of Clinical Psychology program delivered treatment.

Treatments were delivered face-to-face up to 16 x 1 hour sessions, once a week for 16 weeks. Treatment was delivered to individual families only. Both parent/s and child attended each session. Treatment was delivered in a urban community-based psychology clinic. Following treatment families were offered 5 monthly booster sessions by phone to consolidate sessions.

Both treatments were manualised. Supplementary handouts were provided at the majority of sessions. The PMT treatment was based on Russell Barkley's Defiant Child Manual with minor modifications adopted from Ollendick et al.'s 2016 trial.

Adherence to the allocated therapeutic model was assessed by having an independent rater, experienced in both therapies, code random audiotaped therapy sessions using the Session Content Analysis checklist (Ollendick et al., 2016). Independent raters, masked to the treatment being delivered, listened to an audio recording of a therapy session and then rated the presence or absence of treatment components on a 6-item scale. Each therapist also attended regular clinical supervision.
Control group
Active

Outcomes
Primary outcome [1] 328045 0
The Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions
Symptoms of oppositional defiant disorder as assessed by an independent rater conducting a structured interview with a parent/s using the Anxiety Disorders Interview Schedule (ADIS-IV-C/P; Silverman & Albano, 1996). For this study the primary outcome was the Clinician Severity Score (CSR) is CSR rating (0/8) taken from the Oppositional Defiant Disorder (ODD) component of the interview. ODD symptoms were based on the DSM-IV.
Timepoint [1] 328045 0
Baseline, 1-3 weeks following treatment completion (primary timepoint), 6 months after intervention completion (follow-up).
Primary outcome [2] 328046 0
The Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions
A clinical diagnosis of oppositional defiant disorder as assessed by an independent rater conducting a structured interview with a parent/s using the Anxiety Disorders Interview Schedule (ADIS-IV-C/P; Silverman & Albano, 1996). The diagnostic cut-off, used as a measure of remission, is met at a Clinician Severity Rating of 4 on an oppositional defiant disorder scale of 0-8.

Timepoint [2] 328046 0
Baseline, 1-3 weeks following treatment completion (primary endpoint), 6 months after intervention completion (follow-up).
Secondary outcome [1] 397327 0
Disruptive Behavior Disorders Rating Scale
The DBDRS (Pelham et al., 1992) is a 41-item parent questionnaire developed to measure symptoms that reflect DSM-IV criteria for ODD. Parents scored each item on a 4-point scale ranging from 0 (never or rarely) to 3 (very often). Following Barkley’s guidelines, each item reaching the threshold score of two or higher is considered an endorsed symptom and recoded with a score of one. The secondary outcome is reaching four or more of the eight ODD items (in this case a diagnosis of ODD is suggested).
Timepoint [1] 397327 0
Baseline, 1-3 weeks following treatment completion, 6 months after intervention completion (follow-up).

Eligibility
Key inclusion criteria
• Sex: Female and male
• Age range: 7-14 years
• Disorder status: Patient must meet criteria for oppositional defiant disorder
• Concomitant disorder status: Patient will be included in the study if they have a
secondary diagnosis of anxiety or depression.
• Willingness to give written informed consent and willingness to participate to and comply
with the study.
Parent inclusion criteria:
Female and male
Biological parent or grandparent, caregiver of 7-14 year old with oppositional defiant disorder
Willingness to give written informed consent and willingness to participate to and comply
with the study.
Minimum age
7 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants were excluded if they met the full diagnostic criteria for CD, autism spectrum disorder, developmental delay, substance abuse, or high risk of suicide. The taking of psychotropic medications, either prescribed before or during the study, was permitted though participants were encouraged to maintain a consistent regime during the 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)
Once determined eligible for the trial at the initial ADIS-IV-C/P assessment, families were randomly assigned by a central administrator, using a block randomization procedure (to ensure similar group size). The first family was randomly allocated to PMT or CPS via numbered containers, and subsequent families were then allocated using block randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Block randomisation
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
A power analysis was conducted using the simr R package (Green & MacLead, 2016) to test the difference between two independent group means using multilevel linear models, a medium effect size based on a previous clinical trial (d = .50), and an alpha of .05. Results showed that a total sample of 128 participants with two equal sized groups of n = 64 was required to achieve a power of .80. Assuming a 20% dropout rate, we aimed to recruit 80 participants per group.

To study the effects of treatment, the primary data analytic tool was Hierarchical Linear Growth Modelling, an advanced regression model for Windows (HLGM, Version 8; Raudenbush et al., 2019). HLGM was chosen to analyze continuous data because this technique allows for the modeling of intercepts and slopes where the treatment outcomes contain longitudinal data, and where observations are nested within individuals and are likely to have correlated error terms (Raudenbush et al., 2019). We estimated two sequential models. The unconditional model was initially undertaken, which examined symptom severity change across time, with separate analyses undertaken for both the DBDRS and the ADIS CSR. The unconditional model for each outcome measure was then compared to a predictor model, which included the addition of the intervention (CPS vs. PMT) and the covariates of sex and age to determine whether the full predictor model better fit the data.
In addition to traditional null hypothesis significance testing, which examines differences between conditions, equivalence testing was conducted to enable conclusions about group comparability (Rogers et al., 1993). A two one-sided t-test (TOST) examined whether differences between treatments were too small to be considered practically

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2015
Date of last participant enrolment
Anticipated
Actual
22/06/2018
Date of last data collection
Anticipated
Actual
31/12/2018
Sample size
Target
160
Accrual to date
Final
160
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 34449 0
2065 - Crows Nest

Funding & Sponsors
Funding source category [1] 308947 0
Charities/Societies/Foundations
Name [1] 308947 0
Charles Warman Foundation
Country [1] 308947 0
Australia
Primary sponsor type
University
Name
University of Technology Sydney
Address
15 Broadway, Ultimo New South Wales 2007
Country
Australia
Secondary sponsor category [1] 309869 0
None
Name [1] 309869 0
Address [1] 309869 0
Country [1] 309869 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308834 0
UTS Human Research Ethics Committee (HREC 2014000159)
Ethics committee address [1] 308834 0
15 Broadway, Ultimo New South Wales 2007
Ethics committee country [1] 308834 0
Australia
Date submitted for ethics approval [1] 308834 0
02/06/2014
Approval date [1] 308834 0
02/09/2014
Ethics approval number [1] 308834 0
UTS HREC REF NO. 2014000159

Summary
Brief summary
The primary purpose of this study was to examine if participants in the Collaborative and Proactive Solutions and Parent Management Training groups, treated in a community setting, would exhibit significant improvement in ODD symptoms at post-treatment and 6-month follow-up. We were also investigating if improvement in the CPS group would be similar to outcomes in the PMT condition. This study featured components of efficacy studies (studies set in universities with stringent criteria) and effectiveness studies (studies set in community settings with experienced settings). We further expected that there would be no differences in treatment outcomes related to elements of efficacy and effectiveness design (Michelson et al., 2013). In all, it was intended that this study would strengthen conclusions reached about the effectiveness of CPS by reproducing earlier RCT's in a community setting in Sydney, Australia.
Trial website
N/a
Trial related presentations / publications
N/a
Public notes
Results are not disclosed at present (pending publication)

Contacts
Principal investigator
Name 112058 0
Dr Rachael Murrihy
Address 112058 0
Parkes 10 East, Prince of Wales Hospital
High St Randwick Sydney NSW 2031
Country 112058 0
Australia
Phone 112058 0
+61 0414 306 362
Fax 112058 0
+61 2 9399 3068
Email 112058 0
[email protected]
Contact person for public queries
Name 112059 0
Rachael Murrihy
Address 112059 0
Parkes 10 East, Prince of Wales Hospital
High St Randwick Sydney NSW 2031
Country 112059 0
Australia
Phone 112059 0
+61 2 9514 4077
Fax 112059 0
+61 2 9399 3068
Email 112059 0
[email protected]
Contact person for scientific queries
Name 112060 0
Rachael Murrihy
Address 112060 0
Parkes 10 East, Prince of Wales Hospital
High St Randwick Sydney NSW 2031
Country 112060 0
Australia
Phone 112060 0
+61 2 9514 4077
Fax 112060 0
+61 2 9399 3068
Email 112060 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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12249Study protocol  [email protected]
12250Statistical analysis plan  [email protected]
12251Informed consent form  [email protected]
12252Ethical approval    382250-(Uploaded-24-06-2021-16-34-32)-Study-related document.docx



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.