None listed
Conditions
Brief summary
This is a nationwide study funded by the National Health and Medical Research Council that will determine the clinical efficacy, cost -effectiveness and patient acceptability of a new treatment for children who have anxiety disorders. For many children and their parents, anxiety can be highly disruptive and prevent children from doing things that other children their age can do. Participants will be 380 anxious children aged 7 - 12 years. This project will examine two computer-delivered treatment conditions and determine if they are as effective as each other in alleviating children’s anxiety disorders. Children will be randomly assigned into one of two treatment conditions that are delivered via computer at home. One treatment condition is called positive search training (PST), this will take 30 minutes to complete, 4 times a week over 3 weeks on a computer, laptop or tablet. Children view a wide variety of pictures and learn to focus their attention on the positive and calm pictures among them. PST also includes verbalisations, catch phrases and interactive games. The second treatment program is called cognitive behavioural training (CBT). Children complete 10 sessions (one per week) over 10 weeks and parents complete 6 sessions over 10 weeks, on a computer, laptop or tablet. The sessions are 20 - 60 minutes in duration, and include a variety of interactive games, quizzes and animations. Both treatment conditions are accompanied with instructions and phone calls to assist with setting up the treatment at home and children's progress will be monitored by therapists and project staff throughout the duration of treatment. The following hypotheses will be examined: (a) Primary clinical outcome: PST will produce significantly greater reductions on the primary outcome measure of clinician rated diagnostic anxiety severity by the post-PST end-point compared to computer-delivered CBT. By the primary 6-month end-point, PST will be non-inferior to CBT. Between the post-PST and 6-month end-points, diagnostic severity will remain low in children who received PST and decline in children who received CBT, such that any differences between PST and CBT will be clinically unimportant at the 6-month end-point and the 12-month follow-up. Also examined will be cost effectiveness and patient acceptability. PST will be associated with lower treatment costs and greater child and parent acceptability
Interventions
The project involves a two arm, nationwide randomised controlled non-inferiority trial over five years comparing Positive Search training (PST) and computer-delivered Cognitive Behavioural Therapy (CBT). BRAVE-ONLINE will be used as the referent treatment in the CBT arm; a well-established online CBT program for childhood anxiety disorders.
Positive Search Training
Families randomised to PST will be telephoned within a week of allocation to schedule initial set-up procedures. They will be poste
The project involves a two arm, nationwide randomised controlled non-inferiority trial over five years comparing Positive Search training (PST) and computer-delivered Cognitive Behavioural Therapy (CBT). BRAVE-ONLINE will be used as the referent treatment in the CBT arm; a well-established online CBT program for childhood anxiety disorders. Positive Search Training Families randomised to PST will be telephoned within a week of allocation to schedule initial set-up procedures. They will be posted an information booklet containing information about PST, a rationale for the training given that PST is an explicit form of attention training, information on setting-up PST on the family computer, and the USB drive. A 45-min telephone call will be conducted between the research assistant and parents to cover material in the booklet and set-up PST on their computer. Parents will open PST on the computer in a quiet room in the house and children will complete 4 x PST sessions (25 min per session) each week for 3 weeks. A 5-min weekly scripted call from the research assistant will be conducted to check there are no technical or scheduling difficulties and no other treatments or service usage (e.g., CBT, medication). How it works: PST is programmed in Java, completed on a PC/laptop with headphones and a microphone (provided if necessary) and uses a wide variety of picture stimuli. PST contains 224 trials per session (divided into 9 blocks of different trial sizes) yielding 2688 trials over 12 sessions completed within 3 weeks. Children receive verbal and written instructions that they will learn to ‘look for good’, to ‘look for calm’, to ‘use both options’, and to ‘never give up’ using the positive search strategies. In each of the 9 blocks, children search arrays for ‘good’ (e.g., happy children; cute animals) or ‘calm’ (e.g., a vase; a book) targets or both types of targets among threat distractors in 3x3 and 4x4 arrays of varying size and spacing. They receive verbal and written instructions before each block about which search strategy to use (e.g., ‘look for good’) expressed as melodious jingles that children repeat out loud and are recorded. Children click on the pictures until they select the positive/calm target and then the next trial begins. They are prompted after each block to say out-loud the search strategies they are learning. Children play short intermission games between blocks that emphasise the positive search strategies to increase engagement. They provide treatment satisfaction ratings and hear the catch-phrase jingles before the program closes. Output files containing trial identifiers, reaction-times, number of mouse-clicks on each trial and verbalisations of the search strategies are automatically emailed after each session, this provides monitoring of adherence to the intervention. The treatment is programmed so that it requires the child to complete the session before submitting.
Sponsors
Griffith University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
7 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: (a) child is 7 to 12 years of age; (b) meets criteria for a DSM-5 anxiety disorder, (c) willingness to cease concurrent psychotherapy, (d) willingness to stabilise medication (if applicable) at the same dose for 12 weeks prior to diagnostic assessment. There is no specific inclusion criteria for parents
Exclusion criteria
Exclusion: child with a (a) non-anxiety primary diagnosis, (b) pervasive developmental disorder or intellectual disability, (c) impairments that prevent computer use, (d) prior CBT or PST treatment as reported by parents. A depressive or externalizing disorder secondary to an anxiety disorder will NOT be an exclusion. There is no specific exclusion criteria for parents
Outcome results
None listed