Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001272684
Ethics application status
Approved
Date submitted
17/10/2014
Date registered
4/12/2014
Date last updated
25/05/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Better understanding the role of thinking styles and family factors in the treatment of children and adolescents with Obsessive Compulsive Disorder.
Scientific title
Cognitive-Behavioural Treatment of Obsessive Compulsive Disorder in 8-17 year old participants: Assessing the role of cognitive appraisal processes and family factors.
Secondary ID [1] 285513 0
Nil
Universal Trial Number (UTN)
U1111-1163-0050
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obsessive Compulsive Disorder 293312 0
Condition category
Condition code
Mental Health 293587 293587 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The treatment program involves 12 sessions (delivered over 14 weeks) of individual and family-based CBT based on a program entitled "Cognitive-Behavioral Treatment of Childhood OCD" (Piacentini, Langley, & Roblek, 2007). Individual sessions (with the child) are conducted weekly and family sessions (the child and at least one parent) are conducted every second session, in addition to the individual session. Each session lasts 60 minutes (family and individual). Child-focused sessions focus on psychoeducation about OCD, exposure and response prevention, and cognitive therapy to target unhelpful beliefs. Child-focused sessions also include a brief 10 to 15 minute check in with parents towards the end of the session to outline skills learnt in the session and home-practice activities. Homework assignments will involve exposure exercises (imaginal or in vivo) and behavioural experiments for the children and limits on accommodation for parent(s).

In addition to accompanying their child to weekly child-focused sessions, parents are asked to attend six 60-minute family sessions with their child on a fortnightly basis. These sessions are in addition to the usual 60-minute session. On weeks where there is a family session scheduled, parents may not need to join the child-focused session. Family sessions conducted fortnightly involve both the parents and the child. Family sessions include education about OCD in order to reduce negative feelings of guilt and blame and to normalise family functioning in an OCD context. They are also designed to support families in better managing challenges associated with OCD. This includes assistance with managing emotions, improving communication and skills related to working well together as a family.

The results pertaining to this manual show that 12 sessions over 14 weeks are adequate to achieve significant improvement in OCD symptoms and family functioning. The treatment program demonstrates comparable outcomes when compared to other well-regarded treatment manuals for pediatric OCD (e.g., Barrett, Healy-Farrell, & March, 2004; Pediatric OCD Treatment Study Team, 2004; Storch et al., 2007). This program was also selected due to suitability for both child and adolescent populations. In addition, the program includes a substantial family component relevant to research aims and in line with published literature highlighting the importance of targeting family factors to improve treatment outcomes.

We are implementing an updated version of this manual (Peris & Piacentini, 2013). This updated CBT treatment manual has recently been trialled with improved outcomes compared to the original version (Peris & Piacentini, 2014; Piacentini, Langley, & Roblek, 2007). Written permission has been received from the authors of the manual to implement the updated program as part of the treatment tracking series.

Treatment for the OCD treatment tracking series will be conducted by Sharlene Mantz (Registered Psychologist/USYD PhD candidate) and Chloe McGrath (Registered Clinical Psychologist/USYD MSc candidate). These clinicians are experienced in the assessment and treatment of OCD in children and adolescents, and have current working with children checks.
Intervention code [1] 290456 0
Behaviour
Intervention code [2] 290604 0
Treatment: Other
Comparator / control treatment
The study uses a multiple baseline design with participants serving as their own controls. This is achieved by monitoring participants for 2-3 weeks prior to commencing treatment.

Monitoring of participants will involve asking them to complete questionnaires at home weekly for 2 to 3 weeks before commencing the treatment program. Questionnaires will include both pre-treatment and tracking measures.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 293399 0
Primary Outcome 1: OCD symptoms as assessed using Anxiety Disorders Interview Schedule - IV (ADIS-IV) and Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS).
Timepoint [1] 293399 0
Pre and post treatment and at 1-month follow-up. Children's Obsessive Compulsive Inventory (ChOCI) will be given weekly to children and parents as a tracking measure.
Primary outcome [2] 293400 0
Primary Outcome 2: Cognitive appraisals as assessed by Obsessive Beliefs Questionnaire - Child Version (OBQ-CV).
Timepoint [2] 293400 0
Pre and post treatment and at 1-month follow-up. A small number of items from the OBQ-CV will be given weekly.
Primary outcome [3] 293401 0
Primary Outcome 3: Family factors as assessed by Family Accommodation Scale - Parent Rated (FAS-PR) and Parent Attitudes and Beliefs Scale (PABS).
Timepoint [3] 293401 0
Pre and post treatment and at 1-month follow-up. The family accommodation subscale of the PABS will be given weekly.
Secondary outcome [1] 310937 0
Secondary Outcome 1: Anxiety symptoms as assessed using Spence Children's Anxiety Scale (SCAS).
Timepoint [1] 310937 0
Pre and post treatment and at 1-month follow-up. An anxiety rating will also be obtained each week.
Secondary outcome [2] 310938 0
Secondary Outcome 2: Depression symptoms as assessed using the Children's Depression Inventory (CDI).
Timepoint [2] 310938 0
Pre and post treatment and at 1-month follow-up.
Secondary outcome [3] 311413 0
Secondary Outcome 3: Depression, anxiety and stress symptoms as assessed using the Depression Anxiety Stress Scales-21 (DASS-21).
Timepoint [3] 311413 0
Pre treatment only.
Secondary outcome [4] 311414 0
Secondary Outcome 4: Parental cognition as assessed by the Obsessive Beliefs Questionnaire-44 (OBQ-44).
Timepoint [4] 311414 0
Pre and post treatment.

Eligibility
Key inclusion criteria
1. Male or female children or adolescents between the ages of 8 and 17 years of age with a primary diagnosis of OCD.
2. Children must be on a stable dosage of medicine and have agreed at consent, in consultation with their GP, to no medication changes for the duration of the study
Minimum age
8 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Colour-blindness or severe visual problems (not correctable by visual aids; accurate vision is necessary to complete the self-report measures)
2. Illiteracy or insufficient understanding of English (proficiency in English language is required for understanding CBT and completing questionnaires and treatment)
3. Individuals with intellectual or cognitive impairments, developmental disorders, psychosis, or IQ<80 (the presence of which may impede understanding of the task, ability to engage in treatment, and the responses made on self-report measures)
4. Individuals receiving another psychosocial treatment or starting psychiatric medication treatment less than 2 months prior to treatment

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)
Participants are being recruited from a local OCD clinic as well as through The University of Sydney, as approved by ethics. Participants on the waitlist will be given the option of participating in the CBT-based treatment study or continuing with a similar CBT-based treatment as provided by the service. Allocation is not randomised.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation is not applicable to this study.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Nil
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We have carefully considered the number of variables (based on weekly tracking measures for OCD symptoms, family accommodation, and cognitive appraisal variables) and tracking time points. The number of participants needed to achieve study objectives was then determined with a power analysis. Based on a single group within-subjects design with 15 tracking time points, power at .8 and a medium effect size (.25), 11 participants are required for statistical significance. Based on a small effect size (.20) 17 participants are needed. Although we expect a moderate to large effect over time, based on treatment studies implementing a similar treatment program with children with OCD (e.g., Peris & Piacentini, 2013; Piacentini et al., 2011) we have accounted for a small effect size in our power analyses in the unlikely event that this occurs.

In taking a conservative approach, we are aiming to recruit a sample of approximately 20 participants. This will enable us to compare the trajectories for specific variables across treatment, thus allowing us to achieve our research aims. In addition, we may divide participants into those who responded early to the program and those who achieved gains later and assess whether these patterns are related to final post treatment outcome. Power analysis for this comparison requires 18 participants.

We have also done a review of the literature, with published studies encompassing similar sample sizes that sufficiently accommodate for the relevant statistical analyses. For example, Ginsburg, Burstein, Becker, and Drake (2011) applied a multiple baseline design and assessed weekly parental ratings of OCD behaviours and family accommodation across seven families (3-8 year old children) during a 12-week intervention designed to reduce compulsive behaviour (via ERP) and improve parenting practices. Sukhodolsky, Gorman, Scahill, Findley, and McGuire (2013) applied a multiple-baseline design to investigate the effects of ERP in six children (age range 9-14 years) with OCD and disruptive behavior. Weekly ratings of OCD symptoms and severity were obtained. Wilson (2003) used a multiple baseline design to examine the efficacy of cognitive therapy for OCD and explore mechanisms of change. Six people with OCD received 10-18 sessions of weekly cognitive therapy and completed structured clinical interviews, validated self-report measures, and idiographic diary ratings along the way.

The study has a within-subjects repeated measures design with approximately 20 children with OCD. Repeated measures ANCOVAs and multiple regressions will be used to assess change trajectories for key variables and to assess rate of change across treatment programme both in terms of any sudden patient gains and comparison of change rate for key appraisals and family variables.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/01/2015
Actual
19/05/2015
Date of last participant enrolment
Anticipated
1/08/2018
Actual
Date of last data collection
Anticipated
1/11/2018
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 3053 0
Concord Repatriation Hospital - Concord
Recruitment postcode(s) [1] 9961 0
2006 - The University Of Sydney
Recruitment postcode(s) [2] 8825 0
2138 - Concord West

Funding & Sponsors
Funding source category [1] 290109 0
Self funded/Unfunded
Name [1] 290109 0
Country [1] 290109 0
Primary sponsor type
Individual
Name
Dr Maree J Abbott
Address
Psychology Clinic, Mackie Building (K01)
The University of Sydney, NSW, 2006
Country
Australia
Secondary sponsor category [1] 288817 0
None
Name [1] 288817 0
Address [1] 288817 0
Country [1] 288817 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291818 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 291818 0
Human Ethics Office
Margaret Telfer Building (K07)
University of Sydney
NSW 2006
Ethics committee country [1] 291818 0
Australia
Date submitted for ethics approval [1] 291818 0
16/05/2014
Approval date [1] 291818 0
25/08/2014
Ethics approval number [1] 291818 0
2014/462
Ethics committee name [2] 291819 0
Sydney Local Health District (SLHD) Human Research Ethics Committee - Concord Repatriation General Hospital (CRGH)
Ethics committee address [2] 291819 0
Research & Ethics Office, Concord Repatriation General Hospital
Building 75, Hospital Road, Concord NSW 2139
Ethics committee country [2] 291819 0
Australia
Date submitted for ethics approval [2] 291819 0
29/08/2014
Approval date [2] 291819 0
23/02/2015
Ethics approval number [2] 291819 0
HREC/11/CRGH/277; CH62/6/2011-188

Summary
Brief summary
The study seeks to further understand the role of thinking styles and family factors in children and adolescents suffering from obsessive compulsive disorder (OCD). The study will achieve this by providing Cognitive Behavioural Treatment to a small number of children with OCD while adopting a session by session tracking method. An approved treatment protocol will be applied by an experienced clinician(s), and a variety of measures will be used each session to allow for a thorough investigation into the relationship between thinking styles and family factors and the nature of OCD symptom change.
Trial website
Trial related presentations / publications
Public notes
The treatment study will be conducted at Rivendell Child, Adolescent and Family Unit. This is considered to be part of Concord Repatriation Hospital. The treatment study will also be conducted at The University of Sydney Psychology Clinic.

Contacts
Principal investigator
Name 52158 0
Dr Maree J Abbott
Address 52158 0
Psychology Clinic, Mackie Building (K01)
The University of Sydney, NSW, 2006
Country 52158 0
Australia
Phone 52158 0
+61 2 9351 2644
Fax 52158 0
+61 2 9351 7328
Email 52158 0
maree.abbott@sydney.edu.au
Contact person for public queries
Name 52159 0
Dr Maree J Abbott
Address 52159 0
Psychology Clinic, Mackie Building (K01)
The University of Sydney, NSW, 2006
Country 52159 0
Australia
Phone 52159 0
+61 2 9351 2644
Fax 52159 0
+61 2 9351 7328
Email 52159 0
maree.abbott@sydney.edu.au
Contact person for scientific queries
Name 52160 0
Dr Maree J Abbott
Address 52160 0
Psychology Clinic, Mackie Building (K01)
The University of Sydney, NSW, 2006
Country 52160 0
Australia
Phone 52160 0
+61 2 9351 2644
Fax 52160 0
+61 2 9351 7328
Email 52160 0
maree.abbott@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

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Documents added automatically
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