Alleviating specific phobias experienced by children trial (ASPECT)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2016
INTERVENTION: Participants will be randomised to either the intervention group or the control group and will be stratified by age and recruitment source using an allocation ratio of 1:1. Allocation to groups will be conducted remotely through a secure web‐based program designed by the Sheffield Clinical Trials Unit (CTRU) following consent and completion of the baseline measures. Intervention group: Participants randomised to the intervention group will receive One Session Treatment (OST). OST is a variant of CBT based interventions and uses many of the same techniques that CBT uses. However, whereas CBT delivers these techniques weekly through hourly sessions, OST takes a more condensed approach. OST involves a combination of treatment techniques including graduated exposure therapy, participant modelling, reinforcement, psycho‐education, cognitive challenges and skills training, consolidated into a single three‐hour session. Control group: Participants allocation to the control group will receive Cognitive Behavioural Therapy (CBT). CBT is a form of psychological therapy that uses both cognitive and behavioural techniques to help people to change unhelpful thinking patterns and behaviours arising in response to certain situations. CBT aims to help a child/young person with specific phobia to 1. Recognise anxious feelings and bodily reactions to anxiety 2. Gradually confront their feared situations until their anxiety subsides 3. Capture and challenge anxious or scary thoughts when faced with a phobic situation or object 4. Develop coping strategies and use anxiety management techniques, especially if distress and physical symptoms become overwhelming and the child cannot stay in the feared situation for the purposes of therapy. CBT based interventions are often delivered in hourly sessions every week. There is no recommended number of CBT sessions for specific phobias; however, it is often the case that a child receives 6 to 12 sessions of CBT. Follow‐up will take place 6‐mo CONDITION: Specific phobias ; Mental and Behavioural Disorders ; Specific phobias PRIMARY OUTCOME: The level of fear and avoidance associated with a specific phobia will be assessed using the Behavioural Approach Test (BAT) at baseline and 6 months. INCLUSION CRITERIA: 1. Aged between 7 and 16 years 2. Experience at least one specific phobia as defined by DSM‐IV criteria, which will be assessed using the Anxiety Disorder Interview Schedule (ADIS). These criteria are: 2.1. Marked and out of proportion fear to a specific object or situation 2.2. Exposure provokes immediate anxiety 2.3. The phobic situation(s) is avoided where possible 2.4. The avoidance or distress interferes with the person's routine or functioning (e.g. learning, sleep, social activities) 2.5. Present for 6 months or more SECONDARY OUTCOME: 1. The presence of a specific phobia diagnosis and any accompanying impact of the phobia will be measured using the Anxiety Disorder Interview Schedule (ADIS) at baseline and 6 months; 2. The impact of the specific phobia on daily life will be measured using The Child Anxiety Impact Scale (CAIS) at baseline and 6 months; 3. The degree of general anxiety and depression will be measured using The Revised Childrens Anxiety and Depression Scale (RCADS) at baseline and 6 months; 4. Health related quality of life will be measured using EQ‐5D‐Y and Child Health Utility‐9D (CHU‐9D) questionnaires at baseline and 6 months; 5. Progress towards a specific goal set by the child and their parent/guardian will be measured using a goal‐based outcome measure developed by the study team and based on extant literature at baseline and 6 months; 6. Cost effectiveness will be measured using a health resource utilisation questionnaire developed by a health economist and the wider ASPECT research team at baseline and 6 months; 7. Fidelity to CBT and OST delivery is measured using the OST Rating Scale and the Cognitive Behavioural Therapy Scale for Children and Young People (CBTS‐CYP) at baseline and 6 months. These outcome measures are not completed by the participants or their parents/guardians. Instead, they are completed as part of routine clinical supervision within Child and Adolescent Mental Health Services (CAMHS) and Improving Access to psychological Therapies services (IAPT).
Epistemonikos ID: 349eaada086b30e0eae07c63204d345d01c8fca3
First added on: Aug 24, 2024