None listed
Conditions
Brief summary
To determine the effectiveness and clinical utility of the fear conditioning and extinction task (CON-EXT) Predictive Marker Task and targeted Cognitive Behavioural Therapy (CBT) for children with anxiety disorders with 62 anxious children between 7-12 years. Additionally, to examine clinician and consumer feasibility and acceptability of the CON-EXT Predictive Marker Task. Following evidence-based multi-modal assessment, including delivery of the CON-EXT Predictive Marker Task, all children will receive standard CBT (10 weekly sessions) with the child and treating clinician remaining masked to CON-EXT Marker status. The post-treatment assessment and a one-month post-treatment follow-up assessment will be conducted by independent clinicians masked to children’s prior assessments and CON-EXT Marker status. The post-CBT assessment at primary end-point addresses the key question of whether CBT produces greater clinical benefits in Marker (+) than Marker (-) anxious children. The follow-up assessment addresses the question of whether greater clinical benefits of CBT for Marker (+) than Marker (-) anxious children persist after treatment. It is expected that participants who had a positive score in the CON-EXT task, will respond better to cognitive behavioural treatment than those participants who had a negative score in the CON-EXT task.
Interventions
Participants will be 62 anxious children of any sex and racial and ethnic background who provide assent and their parent/carer who provides consent. The CON-EXT Predictive Marker Task. (approximately 1 - 2 weeks before CBT begins) The fear conditioning and extinction task (CON-EXT) Predictive Marker Task involves two-steps; (1) Identify CON-EXT Markers at the individual patient level and (2) Profile them against the CON-EXT Marker (+) Reference Sample of responders to Cognitive Behavioural Therapy (CBT). Clinicians will follow detailed instructions provided in the CON-EXT Predictive Marker Task Manual and video-recorded training resources which describe and demonstrate all procedures in administering, scoring, and profiling the CON-EXT Predictive Marker Task. All CON-EXT Predictive Marker Task assessments will be audiotaped and 20% will undergo masked review to confirm fidelity and compliance 1. Identify: All children’s CON-EXT markers will be assessed at baseline using computer-based Presentation and Biopac systems. The CON-EXT Predictive Marker Task is based on the fear conditioning and extinction task used in our prior studies and involves habituation (2 trials per stimulus), conditioning (12 trials per stimulus) and extinction (12 trials per stimulus). The Conditioned Stimulus (CSs) are shapes presented for 8-sec each and the US is a 3-sec sound of metal on slate (95dB) presented through headphones on CS+ trials during conditioning and omitted during habituation and extinction. The clinician attaches electrodes to the child’s hand to record skin conductance response scores (SCRs) trial-by-trial and instructs the child how to provide CS evaluations (ratings 1-9 scale) on the keyboard before and after each phase. Headphones are fitted and children are instructed to focus attention on the computer screen and provide responses when prompted. After the task, SCRs are scored by the clinician using Acqknowledge software, converted to microsiemens and averaged across blocks of 2 trials using our scoring programs. Blocked SCR and CS evaluation data are summarised on individual Participant Scoring Forms. 2. Profile: The clinician will then use the summarised SCR and CS evaluation scores from the Participant Scoring Form and plot them on the CON-EXT Profile relative to the CON-EXT Marker (+) Reference Sample who responded to CBT and whose scores are represented by the green bands for CS valence ratings and SCR responses. The orange band represents one standard deviation from the CBT responder range and the red band represents one standard deviation above the CBT responder range. If a child’s scores fall within the green bands for CS valence and SCR responses, they are identified as CON-EXT Marker (+). If a child’s scores fall within the orange or red bands for CS valence and SCR responses, they are identified as CON-EXT Marker (-). Treatment with CBT. All anxious children will receive 10 weekly sessions of CBT, including 10 child sessions and 6 parent sessions (with a duration of approximately 1 hour per session), using the Take Action Program, which is the evidence-based program completed by the 129 anxious children forming the current CON-EXT Marker (+) Reference Sample. CBT will be delivered by provisionally registered psychologists completing Master of Clinical Psychology Training. They will be trained in manualised CBT for anxiety disorders via a two-day training workshop and weekly supervision by CIA-Waters, CIB-Farrell, and CIC-Sluis, as in past trials. Sessions 1-4 focus on psychoeducation, relaxation strategies and cognitive therapy. Within-session exposure therapy is conducted from sessions 5-10 using individualised exposure hierarchies. Exposure therapy involves developing an exposure hierarchy ladder collaboratively with the participant to identify graded exposure tasks relevant to their specific anxiety/fears. Completion of exposure tasks occurs both within and between sessions. The exposure tasks identified are dependent on the participants specific fears/anxiety and so will vary from person to person. Between-session exposure activities are completed at home. These will depend on the child's fear but could include gradually approaching a dog, giving a talk in front of class, going to a birthday party, going in an elevator, going to the doctor or dentist, going into a dark room in the house, sleeping with the light off as examples. Take Action includes a 1-month booster session and 6 parent sessions. The parent sessions alongside the child sessions - so the child completes a session, and then the parent completes their session straight after (so they are back-to-back) where possible. Sometimes they occur at a different time to the child sessions dependent on parent and child availability to attend sessions, but they always occur within the same week. For assessing adherence to the intervenion, session attendance, duration and content completion will be recorded via the therapist in CBT
Sponsors
Study design
Eligibility
Inclusion criteria
Inclusion: (a) children 7-12 years old; (b) meets criteria for a principal DSM-5 anxiety disorder, (c) parent/carer consent for child to cease concurrent psychotherapy (if relevant), (d) parent/carer consent for child to stabilise medication (if relevant) at the same dose for 12 weeks prior to baseline diagnostic assessment.
Exclusion criteria
Exclusion: children with (a) non-anxiety principal diagnosis, (b) autism, pervasive developmental disorder or intellectual disability, gross developmental delay, (c) medical contraindications, and (d) prior child-focused CBT treatment as reported by parents. Depressive or externalizing disorders secondary to an anxiety disorder will be allowed and will not be exclusion criteria.