Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12616001552471
Ethics application status
Approved
Date submitted
6/10/2016
Date registered
10/11/2016
Date last updated
3/12/2018
Date data sharing statement initially provided
3/12/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of school group-based acceptance and commitment therapy for children with anxiety: a randomised controlled trial
Scientific title
Effectiveness of school group-based acceptance and commitment therapy for children with anxiety: a randomised controlled trial
Secondary ID [1] 290263 0
Nil
Universal Trial Number (UTN)
U1111-1188-3466
Trial acronym
ProACTive
Linked study record
ACTRN12611001280998

Health condition
Health condition(s) or problem(s) studied:
Anxiety in children and young people 300491 0
Condition category
Condition code
Mental Health 300348 300348 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Acceptance and Commitment Therapy group-based manualised therapy program delivered by school counsellors formally trained in Proactive, at the child's school, as 10 x 1 hour sessions over 10 weeks, involving up to 8 children. Parents will have limited involvement. They will receive 2 sessions of 1. 5 hours duration coinciding with session 2 and session 7. The first session will be run by the school counsellors (psychologists trained in ProACTive who will be implementing the groups, using a Powerpoint presentation prepared by the CI. The first session involves psychoeducation around anxiety, ACT, and the ProACTive program. Parents receive a manual containing the information being presented in more detail. They will also have the opportunity to ask any questions relevant to their child's treatment. particular focus will be on parenting a child with anxiety, and how to ensure the skills being taught are generalised.. The 2nd session in week 7 will be conducted by the 2 CIs using a webinar format where parents across the various schools can interact live. Specific focus will be on understanding the upcoming exposure in-session activities, and how to assist with generalisation. It will also be an opportunity to clarify any questions about the skills taught thus far, as well as trouble shooting generally issues that may be applicable across families. Parents will be asked to submit their questions prior to the webinar.
The ACT program will involve the "Proactive" developed at The Children’s Hospital at Westmead, for children aged 7-11 years and 12-17 years, respectively. Groups will be run by 2 school counsellors who are psychologists formally trained in Proactive. Proactive has been empirically evaluated and found to be an effective treatment for children and young people with anxiety. This program incorporates all six ACT core therapeutic processes that target psychopathology including Acceptance, Being Present/Mindfulness, Valued directions, Committed Action, Self-as-context and Cognitive Defusion. Rather than focusing on symptom control, this program will concentrate on anxiety management via supporting children to identify what is important to them and get on with doing what they enjoy and is important to them, whilst encouraging acceptance of anxious thoughts and feelings that may arise in the process of doing so. Sessions involve Formal mindfulness practice is incorporated on commencement of each session. Psychoeducation (sessions 1and2) includes an adolescent-adapted explanation of the ACT model via metaphor and experiential learning approaches. Values cards support understanding of the concept of living a valued life(session2). Defusion (getting some distance from difficult internal experiences) is taught via metaphors and experiential exercises (session 3 onwards). Graded exposure is undertaken using the ACT model whereby the act of confronting the fear is an exercise designed to enhance psychological flexibility, while the therapeutic procedure is what is performed in the presence of the feared situation . Specifically, emphasis is placed on supporting mindful observation and acceptance of anxiety while faced with fear in order to foster committed action in line with self-identified values (from session 4 onwards). Finally, problem solving and social skills are incorporated to facilitate
committed action. The skill of self-compassion is specifically addressed during acceptance psycho-education and in the final session where mindfulness activities using loving kindness are demonstrated.
Intervention code [1] 296058 0
Treatment: Other
Intervention code [2] 296096 0
Behaviour
Comparator / control treatment
Wait list control group. After being waitlisted for a period of 10 weeks, children in this group will commence the Proactive program
Control group
Active

Outcomes
Primary outcome [1] 299824 0
Change in score on The Paediatric Anxiety Rating Scale (PARS)- clinician, child and parent rated
Timepoint [1] 299824 0
Pre-treatment, post-treatment, 6 months post-treatment
Primary outcome [2] 299825 0
Change in the Spence Anxiety Scale for Children (SCAS)- child and parent rated
Timepoint [2] 299825 0
pre, post and 6 months post treatment
Secondary outcome [1] 328205 0
Quality of life as measured by The Child Anxiety Life Interference Scale (CALIS)- child and parent rated
Timepoint [1] 328205 0
pre, post and 6 months post treatment
Secondary outcome [2] 328207 0
Feasibility of running ProACTive in schools as measured by qualitative and quantitative therapist responses on the Feasibility Questionnaire
Timepoint [2] 328207 0
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 six 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 2 parent 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 (more than 1 year behind peers), as reported by parent/caregiver and teacher
3) Complex mental health problems such as psychosis, conduct disorder or active suicidality
4) Attention deficit disorder with hyperactivity that is not well controlled
5) severely depressed and actively suicidal
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 two conditions, Acceptance and Commitment Therapy (ACT), 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.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked randomised list will be created using computer software (i.e. computerised sequence generation) available at https://www.sealedenvelope.com/simple-randomiser/v1/lists
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
All analyses will be conducted on both an intention to treat basis, with participants’ data analysed according to the group to which they were randomized, and completers. For the ITT data from any participants who fail to complete the therapy program will be treated conservatively, with LOCF used. If completer and ITT outcomes are similar, ITT outcomes will be presented only. The main statistical analyses will be a series of mixed model analyses. The first factor, Group, will have two levels (ACT versus Controls). The second factor, Time, is a within subjects, repeated measures factor. Two sets of linear mixed model analyses will be conducted examining the following outcomes: (1) Anxiety: PARS, SCAS (2) Quality of Life: CALIS. The mixed model approach has been selected as it allows for inter-participant and intra-participant variance as well as the inclusion of participants with missing data, whilst maintaining power. The same design used for this study was used by Wuthrich et al (2012), and they used a mixed model approach. We also used this approach for our initial RCT .
Descriptive statistics will be used to score school counselor ratings of feasibility questions, rated on a 5 point Likert scale

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
28/09/2016
Date of last participant enrolment
Anticipated
1/08/2019
Actual
Date of last data collection
Anticipated
13/12/2019
Actual
Sample size
Target
130
Accrual to date
121
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment postcode(s) [1] 14432 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 294647 0
Hospital
Name [1] 294647 0
The Children's Hospital at Westmead, Department of Psychological Medicine
Country [1] 294647 0
Australia
Funding source category [2] 294897 0
Commercial sector/Industry
Name [2] 294897 0
Catholic Education Diocese of Parramatta
Country [2] 294897 0
Australia
Primary sponsor type
Hospital
Name
Sydney Children's Hospital Network
Address
Locked Bag 4001, Westmead NSW 2145
Country
Australia
Secondary sponsor category [1] 293510 0
None
Name [1] 293510 0
Address [1] 293510 0
Country [1] 293510 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296086 0
Sydney Children’s Hospitals Network Human Research Ethics Committee
Ethics committee address [1] 296086 0
The Childrens Hospital at Westmead, Locked Bag 4001, Westmead NSW 2145
Ethics committee country [1] 296086 0
Australia
Date submitted for ethics approval [1] 296086 0
04/07/2016
Approval date [1] 296086 0
22/08/2016
Ethics approval number [1] 296086 0
HREC/16/SCHN/205

Summary
Brief summary
Acceptance and Commitment Therapy (ACT) is rapidly growing in its evidence base for treating a variety of psychological disorders, but it is in an early stage of research in children. At the Children's Hospital at Westmead, Department of Psychological Medicine, we have developed and evaluated the effectiveness of an ACT program (ProACTive) for children and young people with anxiety disorders in the world's first and largest randomised controlled trial in this area. Following its initial successful implementation and evaluation in a hospital clinic setting, this project aims to evaluate the feasibility and effectiveness of a school-delivered ACT program (ProACTive) for children and young people with anxiety disorders.
The program aims to improve quality of life and to assist school students with an anxiety disorder to manage their symptoms so they don't have such a negative interference in their life. We plan to evaluate the program on a group -delivered basis in children aged 7-17 years (primary and high school versions). An RCT will be used to compare two groups (n=65 per group) who receive (1) ProACTive and 2) comparison wait list control group. Controls will be offered the program 10 weeks after recruitment and two assessments (see below) take place 10 weeks apart. The program runs 1 hour every week for 10 weeks and will be implemented by school counsellors trained in ProACTive. It involves learning skills (e.g. mindfulness, acceptance, distancing from thoughts/feelings/sensations, exposure therapy), to assist students manage their anxiety in such a way as they can get on with doing what's important and things they enjoy (i.e. leading a more rich, full and meaningful life). Parents will also be engaged in the program, but with less involvement, undergoing psychoeducation and skills training on 2 occasions: on initiation of treatment and exposure therapy sessions.
Effectiveness
To evaluate the effectiveness of the program, participants in the treatment group and their parents/guardian will be asked to complete some standardised questionnaires and a 30 minutes structured interview: (1) prior to (ii) immediately after and (iii) 6 months after participating in the program. These questionnaires will take approximately 20 minutes to complete and will assess students' level of anxiety, depressive mod symptoms and quality of life. Controls will be assessed on the same measures on 2 occasions 10 weeks apart, prior to receiving the same program.
Feasibility
School counsellors implementing the program will be asked to complete a feasibility questionnaire evaluating the ease of implementation and usefulness of resources
The main aims are:
1) Evaluate the feasibility of implementing ProACTive in a school setting
2) Evaluate the effectiveness of delivering ProACTive in a school setting
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1156 1156 0 0
/AnzctrAttachments/371597-non-drug-device-protocol resubmitted July 28 final 2016 .pdf (Protocol)
Attachments [2] 1157 1157 0 0
/AnzctrAttachments/371597-2016-08-23 - REO 22-08-2016 - Ethics Approval Letter.pdf (Ethics approval)

Contacts
Principal investigator
Name 69446 0
Dr Karen Hancock
Address 69446 0
SCHN
The Childrens Hospital at Westmead
Department of Psychological Medicine
Locked Bag 4001
Westmead NSW 2145
Country 69446 0
Australia
Phone 69446 0
+612 98450408
Fax 69446 0
+612 98450413
Email 69446 0
karen.hancock@health.nsw.gov.au
Contact person for public queries
Name 69447 0
Karen Hancock
Address 69447 0
SCHN, CHW
Department of Psychological Medicine
Locked Bag 4001
Westmead NSW 2145
Country 69447 0
Australia
Phone 69447 0
+612 98450408
Fax 69447 0
+612 98450413
Email 69447 0
karen.hancock@health.nsw.gov.au
Contact person for scientific queries
Name 69448 0
Karen Hancock
Address 69448 0
SCHN, CHW
Department of Psychological Medicine
Locked Bag 4001
Westmead NSW 2145
Country 69448 0
Australia
Phone 69448 0
+612 98450408
Fax 69448 0
+612 98450413
Email 69448 0
karen.hancock@health.nsw.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No/undecided IPD sharing reason/comment


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
No additional documents have been identified.