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Alleviating specific phobias experienced by children trial (ASPECT)

A non-inferiority randomised controlled trial comparing the clinical and cost-effectiveness of one session treatment (OST) with multi-session cognitive behavioural therapy (CBT) in children with specific phobias

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN19883421
Enrollment
246
Registered
2016-11-30
Start date
2017-05-01
Completion date
Unknown
Last updated
2023-01-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Specific phobias Mental and Behavioural Disorders Specific phobias

Interventions

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 b

Sponsors

Leeds and York Partnership NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: 1. Specific phobias where exposure to the stimulus has the potential to cause harm to the participants, providing the stimulus cannot be safely simulated 2. Specific phobias where exposure therapy is not feasible for the individual child in the context of the study 3. Specific phobias where exposure therapy is not the best first line / available therapy for the individual child' 4. ASPECT will not exclude primarily on the basis of comorbidity; however, as per standard practice, comorbidity will be assessed and monitored by the clinicians and therapists responsible for delivering the therapies. Where comorbidity is likely to impact negatively on the wellbeing of the participants, the participant will be withdrawn from the trial.

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
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).

Countries

England, United Kingdom

Contacts

Public ContactKatie Biggs
c.e.biggs@sheffield.ac.uk+44 (0)114 222 6128

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 23, 2026