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Trial registered on ANZCTR


Registration number
ACTRN12611001280998
Ethics application status
Approved
Date submitted
12/12/2011
Date registered
13/12/2011
Date last updated
13/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Efficacy of acceptance-mindfulness therapy in children with anxiety: a controlled trial
Scientific title
A randomised controlled trial of Acceptance and Commitment Therapy versus Cognitive Behavioural Therapy for anxiety disorders in children and adolescents.
Secondary ID [1] 273593 0
Nil
Universal Trial Number (UTN)
U1111-1126-3789
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anxiety Disorder 279382 0
Condition category
Condition code
Mental Health 285568 285568 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Acceptance and Commitment Therapy group-based manualised therapy program delivered as 10 x 1.5 hour sessions over 10 weeks, involving up to 8 children and their caregivers in each group. The ACT program will involve the 'Cool Mind' and 'Mindchill' programs, developed at The Children’s Hospital at Westmead, for children aged 7-11 years and 12-17 years, respectively. They are both ACT-based adaptations of Cool Kids and Chilled programs, described below, and were designed to conform to the overarching structure of these programs for comparison purposes. These ACT programs were developed on the basis of ACT-consistent protocols adapted from Lee and Semple’s (2008) Mindfulness-Based Cognitive Therapy for Children protocol; Murrell and Wilson’s Acceptance and Commitment Therapy Adapted for Children (Murrell & Wilson, 2003), Cayoun’s MiCBT protocol (Cayoun, 2009), and Harris’ ACT Mindfully Workshops (Harris, 2007). This program incorporates all six ACT core therapeutic processes that target psychopathology (as described above) including Acceptance, Being Present/Mindfulness, Valued directions, Committed Action, Self-as-context and Cognitive Defusion. In Mindchill, adolescents will learn skills to manage the distress associated with anxious thoughts and feelings. For example, rather than the CBT approach to fighting anxiety and being in control, this program will concentrate on anxiety management via supporting adolescents to identify their values and behave in a value-consistent way, whilst encouraging acceptance of anxious thoughts and feelings that may arise in the process of doing so.

Arm 2: Cognitive Behaviour Therapy (CBT) group-based manualised therapy program delivered as 10 x 1.5 hour sessions over 10 weeks, involving up to 8 children and their caregivers in each group. The CBT program will entail the Cool Kids and Chilled (Registered Trademark) programs - for children aged 7-11 years and 12-17 years, respectively - developed at Macquarie University (Rapee et al., 2006). Cool Kids and Chilled (Registered Trademark) assist children to learn skills to recognise their emotions and combat anxiety, encouraging brave behaviour and gradual engagement with feared situations. One section of the Chilled (Registered Trademark) Program “worry wave” will be omitted from the program for the purposes of this research as it was considered to have mindfulness components more consistent with an ACT approach. This is a small component of the overall program.
Intervention code [1] 283879 0
Treatment: Other
Intervention code [2] 283887 0
Behaviour
Comparator / control treatment
Arm 3: Waitlist control group. After being waitlisted for a period of 10 weeks, children and their caregivers in this group will commence the Arm 2, The CBT program
Control group
Active

Outcomes
Primary outcome [1] 286125 0
Presence of DSM-IV Anxiety disorder as measured by the Anxiety Disorders Interview Schedule (ADIS-IV) (Albano & Silverman, 1996)
Timepoint [1] 286125 0
Pre-treatment, post-treatment, 3 months post-treatment and 2 years post-treatment
Primary outcome [2] 286126 0
Clinically significant change in anxiety severity as measured by either ADIS-IV, Multidimensional Anxiety Scale for Children (MASC; March, 1997) and/or Child Behaviour Checklist (CBCL)
Timepoint [2] 286126 0
Pre-treatment, post-treatment, 3 months post-treatment and 2 years post-treatment
Primary outcome [3] 286127 0
Mechanisms of change (adolescent participants only) as measured by changes in experiential avoidance, cognitive fusion, acceptance and valued living
Timepoint [3] 286127 0
Pre-treatment, post-treatment and 3 months post-treatment
Secondary outcome [1] 295201 0
Depression symptoms as measured by the Child Depression Inventory and/or Child Behaviour Checklist (CBCL)
Timepoint [1] 295201 0
Pre-treatment, post-treatment, 3 months post-treatment and 2 years post-treatment
Secondary outcome [2] 295202 0
Quality of life and self-efficacy as measured by the Childrens Anxiety Life Interference Scale Child Form (CALIS-C)
Timepoint [2] 295202 0
Pre-treatment, post-treatment, 3 months post-treatment and 2 years post-treatment

Eligibility
Key inclusion criteria
1) Aged between 7-17 years
2) Meet criteria for a primary diagnosis of a Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) anxiety disorder (including panic disorder and/or agoraphobia, obsessive compulsive disorder, specific phobia, social anxiety disorder or generalised anxiety disorder)
3) Available/able to attend The Children’s Hospital at Westmead for pre-treatment, immediate post-treatment and three month post-treatment assessments as well as attending a minimum of 80% of therapy sessions
4) Have a parent/caregiver who is willing to attend and participate in the assessment as well as a minimum of 80% of therapy sessions
Minimum age
7 Years
Maximum age
17 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Developmental or language delay, as reported by parent/caregiver
2) Non-English speakers
3) Complex mental health problems such as psychosis, conduct disorder or active suicidality
4) Complex medical conditions with a high degree of medical dependence that would prevent them from being able to attend at least 80% of sessions
5) Attention deficit disorder with hyperactivity that is not well controlled
6) Medicated with an anxiolytic/antidepressant for less than 2 months
7) Post-traumatic stress disorder (due to the potential distress caused to other participants in the group and the specialised treatment required for this disorder)
8) Completed < 80% of sessions or dropped out of treatment – Those who become lost to follow-up will be placed in the ’intention to treat’ category

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)
Following referral to the Department of Psychological Medicine, The Children's Hospital at Westmead (CHW) the parents/carers of potential child participants are briefly screened over the phone to determine suitability for baseline assessment using a checklist developed for this study. If deemed suitable at this point, they will be sent an information pack about the study including consent forms, and a battery of questionnaires to be completed by both the child and parent as part of the baseline assessment. Eligible participants and their parents/caregivers will be randomised to one of three conditions, Acceptance and Commitment Therapy (ACT), Cognitive Behaviour Therapy (CBT) or a waitlist control group for a period of 10 weeks.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This is a block randomised controlled trial, with the participant serving as the unit of randomisation. Randomisation will be undertaken via a freely available computer random assignment software application, ‘Graphpad’ (for more information and to access see: www.graphpad.com/quickcalcs/randomize2.cfm). The researchers conducting baseline assessments will be blinded to the treatment type to reduce potential bias and will only become aware of the group allocation upon commencement of the relevant program. The researcher who determined if a participant was eligible for inclusion in the trial was blind to the group allocation process, at the time of allocation. Allocation was performed at a central administration site.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The ACT and CBT treatments are completed as parallel assignment. However, those initially allocated to waitlist control will receive the CBT arm of the intervention after completion of the 10 week waitlist period.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/05/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
150
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 284364 0
Hospital
Name [1] 284364 0
Children's Hospital Westmead, Department of Psychological Medicine
Country [1] 284364 0
Australia
Primary sponsor type
Hospital
Name
Children's Hospital Westmead, Department of Psychological Medicine
Address
Department of Psychological Medicine
Children's Hospital at Westmead
Locked Bag 4001
Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 283303 0
None
Name [1] 283303 0
Address [1] 283303 0
Country [1] 283303 0
Other collaborator category [1] 260394 0
University
Name [1] 260394 0
The University of Newcastle
Address [1] 260394 0
School of Psychology
The University of Newcastle
University Drive
Callaghan NSW 2308
Australia
Country [1] 260394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286323 0
Royal Alexandra Hospital for Children Ethics Committee (EC00130)
Ethics committee address [1] 286323 0
Research and Development
Cnr Hawkesbury Rd and Hainsworth St
Westmead NSW 2145
Ethics committee country [1] 286323 0
Australia
Date submitted for ethics approval [1] 286323 0
01/01/2009
Approval date [1] 286323 0
01/03/2009
Ethics approval number [1] 286323 0
09/CHW/4

Summary
Brief summary
Over the last 15 years mindfulness and acceptance therapies have taken hold in psychology as a new era of
treatment. Acceptance-mindfulness therapies differ from traditional cognitive behavioural therapies (CBT) in that
rather than attempting to change the content, frequency and form of thoughts and feelings, acceptance or
mindfulness-based therapies seek to change the functions of thoughts, feelings and physical sensations so as to
minimise their impact.
While there is growing empirical support for the utility of acceptance-mindfulness treatments for adults with anxiety
and other psychological problems, very little research has been conducted on children evaluating its effectiveness
despite the growing use in children and adolescents. This study aims to conduct a controlled clinical trial evaluating
the efficacy of acceptance-mindfulness therapy for children with anxiety disorders. Children aged 7-17 years will be
randomly allocated to one of 3 groups: acceptance-mindfulness integrated with cognitive behavioural therapy,
cognitive behavioural therapy only, and a waiting list control group. Repeated measures of psychological outcomes will
be taken pre, immediate post and 3 months post-treatment. Parents will also undertake group therapy sessions while the children are undergoing therapy to assist children transfer the skills to everyday life.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33525 0
Address 33525 0
Country 33525 0
Phone 33525 0
Fax 33525 0
Email 33525 0
Contact person for public queries
Name 16772 0
Dr Karen Hancock
Address 16772 0
Department of Psychological Medicine
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street,
Westmead NSW 2145
Country 16772 0
Australia
Phone 16772 0
+61 2 98450408
Fax 16772 0
+61 2 9845 0413
Email 16772 0
[email protected]
Contact person for scientific queries
Name 7700 0
Dr Karen Hancock
Address 7700 0
Department of Psychological Medicine
The Children's Hospital Westmead
Cnr Hawkesbury Road and Hainsworth Street,
Westmead NSW 2145
Country 7700 0
Australia
Phone 7700 0
+61 2 98450408
Fax 7700 0
+61 2 9845 0413
Email 7700 0
[email protected]

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
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