Background: 5%-10% children and young people (CYP) experience specific phobias that impact daily functioning. Cognitive Behaviour Therapy (CBT) is recommended but has limitations. One Session Treatment (OST), a briefer alternative incorporating CBT principles, has demonstrated efficacy. The Alleviating Specific Phobias Experienced by Children Trial (ASPECT) investigated the non-inferiority of OST compared to multi-session CBT for treating specific phobias in CYP. Methods: ASPECT was a pragmatic, multi-center, non-inferiority randomized controlled trial in 26 CAMHS sites, three voluntary agency services, and one university-based CYP well-being service. CYP aged 7-16 years with specific phobia were randomized to receive OST or CBT. Clinical non-inferiority and a nested costeffectiveness evaluation was assessed 6-months post-randomization using the Behavioural Avoidance Task (BAT). Secondary outcome measures included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children's Anxiety Depression Scale, goal-based outcome measure, and EQ-5DY and CHU-9D, collected blind at baseline and six-months. Results: 268 CYPs were randomized to OST (n = 134) or CBT (n = 134). Mean BAT scores at 6 months were similar across groups in both intention-to-treat (ITT) and per-protocol (PP) populations (CBT: 7.1 (ITT, n = 76), 7.4 (PP, n = 57), OST: 7.4 (ITT, n = 73), 7.6 (PP, n = 56), on the standardized scale-adjusted mean difference for CBT compared to OST -0.123, 95% CI À0.449 to 0.202 (ITT), mean difference À0.204, 95% CI À0.579 to 0.171 (PP)). These findings were wholly below the standardized non-inferiority limit of 0.4, suggesting that OST is non-inferior to CBT. No between-group differences were found on secondary outcomes. OST marginally decreased mean service use costs and maintained similar mean Quality Adjusted Life Years compared to CBT. Conclusions: One Session Treatment has similar clinical effectiveness to CBT for specific phobias in CYP and may be a cost-saving alternative.
Previous studies have shown that autistic people often display atypical responses when processing sensory information, with particular prevalence within the auditory domain. Often provoked by common everyday sounds, auditory hypersensitivity can result in self-regulatory fear responses. This can be potentially harmful to autistic individuals and the people around them and is associated with greater occurrence of anxiety, depression, and poorer overall quality of life in the autistic population. Rather than a physiological causation, the literature suggests that hypersensitivity to sound is likely to be caused by how auditory stimuli are processed in the brain. This paper reports a home-based digital intervention aimed to address auditory hypersensitivity in autistic children. Developed as an interactive virtual reality game, the system integrates exposure-based therapy techniques into game mechanics and delivers target auditory stimuli to the player rendered via binaural-based spatial audio. The performance of the platform was evaluated in a 10-week feasibility study, during which children (n = 7) engaged weekly with the game during a 30 min session. Following this period, a comparison of pre- and post-study measurements showed a decrease in sensitivity for five participants, with qualitative feedback highlighting an increase in tolerance towards real-world stimuli and challenging environments. These results provide initial support for SoundFields as a home-based intervention targeting auditory hypersensitivity experienced by autistic children.
Background Up to 10% of children and young people have a specific phobia that can significantly affect their mental health, development and daily functioning. Cognitive–behavioural therapy-based interventions remain the dominant treatment, but limitations to their provision warrant investigation into low-intensity alternatives. One-session treatment is one such alternative that shares cognitive–behavioural therapy principles but has a shorter treatment period. Objective This research investigated the non-inferiority of one-session treatment to cognitive–behavioural therapy for treating specific phobias in children and young people. The acceptability and cost-effectiveness of one-session treatment were examined. Design A pragmatic, multicentre, non-inferiority randomised controlled trial, with embedded economic and qualitative evaluations. Settings There were 26 sites, including 12 NHS trusts. Participants Participants were aged 7–16 years and had a specific phobia defined in accordance with established international clinical criteria. Interventions Participants were randomised 1 : 1 to receive one-session treatment or usual-care cognitive–behavioural therapy, and were stratified according to age and phobia severity. Outcome assessors remained blind to treatment allocation. Main outcome measures The primary outcome measure was the Behavioural Avoidance Task at 6 months’ follow-up. Secondary outcomes included the Anxiety Disorder Interview Schedule, Child Anxiety Impact Scale, Revised Children’s Anxiety and Depression Scale, a goal-based outcome measure, Child Health Utility 9D, EuroQol-5 Dimensions Youth version and resource usage. Treatment fidelity was assessed using the Cognitive Behaviour Therapy Scale for Children and Young People and the One-Session Treatment Rating Scale. Results A total of 274 participants were recruited, with 268 participants randomised to one-session treatment (n = 134) or cognitive–behavioural therapy (n = 134). A total of 197 participants contributed some data, with 149 participants in the intention-to-treat analysis and 113 in the per-protocol analysis. Mean Behavioural Avoidance Task scores at 6 months were similar across treatment groups when both intention-to-treat and per-protocol analyses were applied [cognitive–behavioural therapy: 7.1 (intention to treat), 7.4 (per protocol); one-session treatment: 7.4 (intention to treat), 7.6 (per protocol); on the standardised scale adjusted mean difference for cognitive–behavioural therapy compared with one-session treatment –0.123, 95% confidence interval –0.449 to 0.202 (intention to treat), mean difference –0.204, 95% confidence interval –0.579 to 0.171 (per protocol)]. These findings were wholly below the standardised non-inferiority limit of 0.4, which suggests that one-session treatment is non-inferior to cognitive–behavioural therapy. No between-group differences in secondary outcome measures were found. The health economics evaluation suggested that, compared with cognitive–behavioural therapy, one-session treatment marginally decreased the mean service use costs and maintained similar mean quality-adjusted life-year improvement. Nested qualitative evaluation found one-session treatment to be considered acceptable by those who received it, their parents/guardians and clinicians. No adverse events occurred as a result of phobia treatment. Limitations The COVID-19 pandemic meant that 48 children and young people could not complete the primary outcome measure. Service waiting times resulted in some participants not starting therapy before follow-up. Conclusions One-session treatment for specific phobia in UK-based child mental health treatment centres is as clinically effective as multisession cognitive–behavioural therapy and highly likely to be cost-saving. Future work could involve improving the implementation of one-session treatment through training and commissioning of improved care pathways. Trial registration This trial is registered as ISRCTN19883421. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 26, No. 42. See the NIHR Journals Library website for further project information.
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