Precision computerised cognitive behavioural therapy (cCBT) for adolescents with depression: a pilot and feasibility randomised controlled trial protocol for SPARX-UK.

BACKGROUND: A serious game called SPARX (Smart, Positive, Active, Realistic, X-factor thoughts), originally developed in New Zealand and incorporating cognitive behavioural therapy (CBT) principles, has been shown to help reduce symptoms of depression and anxiety in adolescents with mild to moderate depression in studies undertaken in Australasia. However, SPARX has never been trialled in the United Kingdom (UK), and there have been issues relating to low engagement when it has been used in a real-world context. AIMS: To conduct the first pilot and feasibility randomised controlled trial (RCT) in England to explore the use of SPARX in different settings. The trial will explore whether SPARX supported by an e-coach (assistant psychologists) improves adherence and engagement compared with self-directed (i.e. self-help) use. The trial results will be used to inform the optimal mode of delivery (SPARX supported vs. SPARX self-directed), to calculate an appropriate sample size for a full RCT, and to decide which setting is most suitable. METHODS: Following consultation with young people to ensure study suitability/appropriateness, a total of 120 adolescents (11-19 years) will be recruited for this three-arm study. Adolescents recruited for the study across England will be randomised to receive either SPARX with human support (from an e-coach), self-directed SPARX, or a waitlist control group. Assessments will be conducted online at baseline, week 4, and 8-10-week post-randomisation. The assessments will include measures which capture demographic, depression (Patient Health Questionnaire modified for adolescents [PHQ-A]) and anxiety (Revised Child Anxiety and Depression Scale [RCADS]) symptomatology, and health-related quality-of-life data (EQ-5D-Y and proxy version). Analyses will be primarily descriptive. Qualitative interviews will be undertaken with a proportion of the participants and clinical staff as part of a process evaluation, and the qualitative data gathered will be thematically analysed. Finally, feasibility data will be collected on recruitment details, overall study uptake and engagement with SPARX, participant retention, and youth-reported acceptability of the intervention. DISCUSSION: The findings will inform the design of a future definitive RCT of SPARX in the UK. If the subsequent definitive RCT demonstrates that SPARX is effective, then an online serious game utilising CBT principles ultimately has the potential to improve the provision of care within the UK's health services if delivered en masse. TRIAL REGISTRATION: ISRCTN: ISRCTN15124804. Registered on 16 January 2023, https://www.isrctn.com/ISRCTN15124804 .

Beating Adolescent Self-Harm (BASH): a randomised controlled trial comparing usual care versus usual care plus a smartphone self-harm prevention app (BlueIce) in young adolescents aged 12-17 who self-harm: study protocol.

INTRODUCTION: A mobile app, BlueIce, was codesigned with young people with a history of self-harm to provide them with more accessible and available evidence-based support at times of distress. A preliminary evaluation found that BlueIce was acceptable, safe and used by young people and helped to reduce self-harm. The present study is designed to assess the effectiveness and cost-effectiveness of adding BlueIce to usual Child and Adolescent Mental Health Service (CAMHS). METHODS AND ANALYSIS: This study is a single-blind, randomised controlled trial comparing usual CAMHS care with usual care plus BlueIce. A total of 138 adolescents aged 12-17 with current or a history of self-harm will be recruited through the Oxford Health National Health Service (NHS) Foundation Trust via their CAMHS clinician. The primary outcome is self-harm at 12 weeks assessed using the Risk Taking and Self-Harm Inventory for Adolescents. Secondary outcomes include mood, anxiety, hopelessness, general behaviour, sleep and impact on everyday life at 12 weeks and 6 months. Health-related quality of life and healthcare resource utilisation data will be collected at baseline, 12 weeks and 6 months. Postuse interviews at 12 weeks will determine the acceptability, safety and usability of BlueIce. ETHICS AND DISSEMINATION: The study was approved by the NHS South Central-Oxford B NHS Research Ethics Committee (19/SC/0212) and by the Health Research Authority (HRA) and Health and Care Research Wales. Findings will be disseminated in peer review open-access journals and at academic conferences. TRIAL REGISTRATION NUMBER: ISRCTN10541045.

A cluster randomised controlled trial to determine the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents.

BACKGROUND: Depression in adolescents is a significant problem that impairs everyday functioning and increases the risk of severe mental health disorders in adulthood. Although this is a major problem, relatively few adolescents with, or at risk of developing, depression are identified and referred for treatment. This suggests the need to investigate alternative approaches whereby preventative interventions are made widely available in schools. OBJECTIVE: To investigate the clinical effectiveness and cost-effectiveness of classroom-based cognitive-behavioural therapy (CBT) in reducing symptoms of depression in high-risk adolescents. DESIGN: Cluster randomised controlled trial. Year groups ( n = 28) randomly allocated on a 1 : 1 : 1 basis to one of three trial arms once all schools were recruited and balanced for number of classes, number of students, Personal, Social and Health Education (PSHE) lesson frequency, and scheduling of PSHE. SETTING: Year groups 8 to 11 (ages 12-16 years) in mixed-sex secondary schools in the UK. Data were collected between 2009 and 2011. PARTICIPANTS: Young people who attended PSHE at participating schools were eligible ( n = 5503). Of the 5030 who agreed to participate, 1064 (21.2%) were classified as 'high risk': 392 in the classroom-based CBT arm, 374 in the attention control PSHE arm and 298 in the usual PSHE arm. Primary outcome data on the high-risk group at 12 months were available for classroom-based CBT ( n = 296), attention control PSHE ( n = 308) and usual PSHE ( n = 242). INTERVENTIONS: The Resourceful Adolescent Programme (RAP) is a focused CBT-based intervention adapted for the UK (RAP-UK) and delivered by two facilitators external to the school. Control groups were usual PSHE (usual school curriculum delivered by teachers) and attention control (usual school PSHE with additional support from two facilitators). Interventions were delivered universally to whole classes. PRIMARY OUTCOMES: Clinical effectiveness: symptoms of depression [Short Mood and Feelings Questionnaire (SMFQ)] in adolescents at high risk of depression 12 months from baseline. Cost-effectiveness: incremental cost-effectiveness ratios (ICERs) based on SMFQ score and quality-adjusted life-years (from European Quality of Life-5 Dimensions scores) between baseline and 12 months. Process evaluation: reach, attrition and qualitative feedback from service recipients and providers. RESULTS: SMFQ scores had decreased for high-risk adolescents in all trial arms at 12 months, but there was no difference between arms [classroom-based CBT vs. usual PSHE adjusted difference in means 0.97, 95% confidence interval (CI) -0.34 to 2.28; classroom-based CBT vs. attention control PSHE -0.63, 95% CI -1.99 to 0.73]. Costs of interventions per child were estimated at £41.96 for classroom-based CBT and £34.45 for attention control PSHE. Fieller's method was used to obtain a parametric estimate of the 95% CI for the ICERs and construct the cost-effectiveness acceptability curve, confirming that classroom-based CBT was not cost-effective relative to the controls. Reach of classroom-based CBT was good and attrition was low (median 80% attending ≥ 60% of sessions), but feedback indicated some difficulties with acceptability and sustainability. CONCLUSIONS: Classroom-based CBT, attention control PSHE and usual PSHE produced similar outcomes. Classroom-based CBT may result in increased self-awareness and reporting of depressive symptoms. Classroom-based CBT was not shown to be cost-effective. While schools are a convenient way of reaching a wide range of young people, implementing classroom-based CBT within schools is challenging, particularly with regard to fitting programmes into a busy timetable, the lack of value placed on PSHE, and difficulties engaging with teachers and young people. Wider use of classroom-based depression prevention programmes should not be undertaken without further research. If universal preventative approaches are to be pursued, their clinical effectiveness and cost-effectiveness with younger children (aged 10-11 years), before the incidence of depression increases, should be investigated. Alternatively, the clinical effectiveness of indicated school-based programmes targeting those already displaying symptoms of depression should be investigated. TRIAL REGISTRATION: Current Controlled Trials ISRCTN19083628. FUNDING: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 17, No. 47. See the HTA programme website for further project information.

A review and meta-analysis of computerized cognitive behaviour therapy for the treatment of pain in children and adolescents.

BACKGROUND: Chronic pain is relatively common in children and adolescents. Cognitive behaviour therapy (CBT) has been shown to be effective for treating pain in this age group. This paper aims to review the literature on the use of computerized cognitive behavioural therapy (cCBT) with children and adolescents with pain. METHODS: Three databases, Pubmed (including Medline), Embase and PsychInfo, were searched and papers were identified using specific inclusion criteria. RESULTS: Four studies met the inclusion criteria, all of which indicated beneficial results of using cCBT, with those who completed cCBT being more likely to experience at least a 50% post-treatment reduction in symptoms than those in a control group. A meta-analysis suggested a medium effect size of -0.41 for reduced pain intensity post treatment for cCBT compared with the control groups. A mean odds ratio of 6.03 was found for achieving a clinically significant reduction in pain in the cCBT group compared with the control groups. CONCLUSION: This review tentatively suggests potential for using cCBT for pain in children and adolescents. However, there is only a small body of research exploring this relationship at present, and so further research is needed before any solid conclusions can be drawn.

An evaluation of the FRIENDS programme: a cognitive behaviour therapy intervention to promote emotional resilience.

AIMS: To evaluate the efficacy and acceptability of the FRIENDS programme. METHODS: Uncontrolled before and after assessment of the FRIENDS programme, a 10 session cognitive behaviour therapy programme. A total of 213 children aged 9-10 years from six primary schools were studied. MAIN OUTCOME MEASURES: Spence Children's Anxiety Scale, Culture Free Self-Esteem Questionnaire, qualitative assessment of acceptability. RESULTS: End of programme data from 197 children (92.5% of eligible sample) showed significantly lower rates of anxiety (t = 2.95, df = 384) and significantly improved levels of self-esteem (t = 3.13, df = 386). Significant improvements were obtained in over half of those children with the most severe emotional problems. A total of 190 children (89.2%) completed a qualitative assessment of acceptability: 154 (81%) thought it was fun, 147 (77.4%) would recommend it to a friend; 137 (72.8%) thought they had learned new skills, and 78 (41.1%) had helped someone else with their new skills. CONCLUSIONS: The FRIENDS programme appears to be an efficacious and acceptable way to promote emotional resilience (reduced anxiety and increased self-esteem) in primary school aged children, consistent with previous studies in Australia. Further controlled studies are needed to assess natural history of anxiety and self-esteem and whether benefits are maintained over time.

Pain in cognitively impaired, non-communicating children.

AIM: To detail the everyday occurrence of pain in non-communicating children with cognitive impairment. METHODS: Thirty four parents of cognitively impaired verbally non-communicating children completed pain diaries over a two week period. Each day, for five defined periods, parents rated whether their child had been in pain, and if so, its severity and duration. RESULTS: Twenty five (73.5%) children experienced pain on at least one day, with moderate or severe levels of pain being experienced by 23 (67.6%). Four children (11.7%) experienced moderate or severe pain lasting longer than 30 minutes on five or more days. No child was receiving active pain management. CONCLUSIONS: Everyday pain in children with severe cognitive impairment is common, yet is rarely actively treated.

Prevalence and morbidity associated with non-malignant, life-threatening conditions in childhood.

OBJECTIVE: To determine the prevalence of non-malignant life-threatening illness in childhood and associated morbidity in the affected child and their family members. DESIGN: Cross-sectional survey. SETTING: Bath Clinical Area (total population 411,800). SUBJECTS: Children aged 0-19 years. RESULTS: One hundred and twenty-three children were identified, giving a prevalence of 1.2/1000 children. Morbidity assessed in 93 children showed 60% in pain or discomfort, 35% unable to walk and 25% with severe cognitive impairment. Mental health problems were found in 54% of mothers and 30% of fathers, and significant emotional and behavioural problems in 24% of healthy siblings. CONCLUSIONS: Non-malignant life-threatening illness is more prevalent than reported in previous studies. Considerable morbidity is experienced by the child and their family. An individual and family approach is required. Key messages (1) The prevalence of non-malignant life-threatening illness is four times greater than previous estimates. (2) This group of conditions have significant implications for all family members. (3) Early comprehensive assessment and access to effective interventions may pre-empt later problems.

Coping and psychological distress in children involved in road traffic accidents.

OBJECTIVE: The purpose of this study is to detail the natural coping strategies used by children involved in everyday road traffic accidents (RTAs). The relationship between coping strategies, post-traumatic stress disorder (PTSD), gender and age was investigated. DESIGN: Children aged 7-18 who attended an accident and emergency department following involvement in a RTA were assessed, 6 weeks after their accident (N = 97). A subgroup of 36 children were re-assessed approximately 8 months after the trauma. METHODS: The presence of PTSD was determined via a semi-structured interview incorporating the Clinician Administered Post-traumatic Scale for Children (CAPS-C). Self-completed psychometric assessments were undertaken to assess the presence of clinically significant levels of depression (Birleson Depression Inventory), anxiety (Revised Manifest Anxiety Scale) and coping style (Kidcope). RESULTS: Children involved in RTAs used between 5 and 7 different coping strategies. Younger children and those with PTSD used more strategies than older children and those not suffering from PTSD. Children with PTSD were more likely to use the strategies of distraction, social withdrawal, emotional regulation and blaming others. CONCLUSION: The limitations of Kidcope are discussed and the need to develop more complex ways of assessing childhood coping within a developmental framework highlighted.

Psychological screening of children for post-traumatic stress disorder.

One hundred and seventy children attending a hospital accident and emergency department following everyday trauma were interviewed and completed the Post-traumatic Stress Disorder (PTSD) screening battery suggested by Yule and Udwin (1991). Diagnostic interviews (CAPS-C) confirmed that 39 (22.9%) fulfilled the DSM-IV criteria for PTSD. There were significant differences between children with and without PTSD on each individual component of the screening battery. Various criteria for caseness were evaluated and at 6 weeks post trauma the screen identified up to 90% of children diagnosed with PTSD and 73% with borderline conditions. A subset of 36 children were reassessed 8 months post trauma and all children with persistent PTSD were correctly identified by initial screen scores. The limitations of the study and the role of screening for PTSD in the absence of proven psychological interventions are discussed.

Prospective study of post-traumatic stress disorder in children involved in road traffic accidents.

OBJECTIVE: To determine the prevalence of severe psychological trauma --that is, post-traumatic stress disorder--in children involved in everyday road traffic accidents. DESIGN: 12 month prospective study. SETTING: Accident and emergency department, Royal United Hospital, Bath. SUBJECTS: 119 children aged 5-18 years involved in road traffic accidents and 66 children who sustained sports injuries. MAIN OUTCOME MEASURE: Presence of appreciable psychological distress; fulfillment of diagnostic criteria for post-traumatic stress disorder. RESULTS: Post-traumatic stress disorder was found in 41 (34.5%) children involved in road traffic accidents but only two (3.0%) who sustained sports injuries. The presence of post-traumatic stress disorder was not related to the type of accident, age of the child, or the nature of injuries but was significantly associated with sex, previous experience of trauma, and subjective appraisal of threat to life. None of the children had received any psychological help at the time of assessment. CONCLUSIONS: One in three children involved in road traffic accidents was found to suffer from post-traumatic stress disorder when they were assessed 6 weeks after their accident. The psychological needs of such children after such accidents remain largely unrecognised.

The impact of childhood non-malignant life-threatening illness on parents: gender differences and predictors of parental adjustment.

Mental health, family functioning, effects on employment and relationships, coping style, and perceptions of prognosis were assessed in 93 mothers and 78 fathers of children with a life-threatening non-malignant condition. Results indicated high levels of psychological distress, significant effects upon employment and relationships, and a family environment characterised by low expressiveness, cohesion, and high conflict. Differences between mothers and fathers were found on a number of variables. Length of time since diagnosis, level of family cohesion, and sex of parent significantly predicted parental mental health.

Validity and reliability of the Parent Satisfaction Questionnaire.

The development of a postal consumer satisfaction questionnaire for a child and adolescent psychology service is reported. A preliminary analysis of content, construct and concurrent validity suggests that the questionnaire has an acceptable degree of validity. Factor analysis identified five factors with three being identifiable as relating to the outcome of contact, appointments and the timing of contact. The remaining two factors were minor dyads which were difficult to interpret. The reliability and utility of the questionnaire is good, proving a useful way of identifying service shortfalls and directing service change. The need to methodologically evaluate consumer satisfaction questionnaires is stressed and their routine use in monitoring and assuring service quality highlighted.

Parental satisfaction with intervention: differences between respondents and non-respondents to a postal questionnaire.

Parental satisfaction with a child and adolescent psychology service was assessed by postal questionnaire. Follow-up interviews were conducted with 88 percent of the sample, 36 postal questionnaire respondents and 21 non-respondents. Questionnaire non-respondents were more likely to have dropped out of therapy, had fewer appointments, evaluated the service more negatively and differed from respondents in their particular sources of dissatisfaction. They were significantly more dissatisfied with where they met the psychologist and in what family composition they were seen whereas questionnaire respondents were more dissatisfied with the wait before first appointment and the total number of appointments offered. The implications for future studies are discussed and the need to assess the satisfaction of postal non-respondent emphasized.

Development and satisfaction with individual programme planning in a disability service.

A consumer survey of a preschool disability service identified parents who did not feel their concerns were fully understood by professionals, nor felt involved or in agreement with treatment decisions, nor that services were provided in a coordinated way. A system of individual programme planning (IPP) was introduced in order to address these issues and other shortfalls of the existing service. Information was obtained from 96% of parents and 87% of professionals who attended IPP meetings over a four month period. Overall satisfaction was high (92% of parents: 96% of professionals). Parents now felt fully involved in decision making, 80% felt their views were understood and 100% agreed with treatment goals. Dissatisfaction was expressed with meeting attendance, the marginalisation of parents, and the timing and chairing of meetings. Consumer satisfaction surveys are recommended for use in highlighting areas of service shortfall, to direct and evaluate service change, and to monitor quality.

Groups for parents of pre-school children with severe disabilities.

The emotional impact upon the family following the diagnosis of a child's disability is significant although parents feel that their needs are not specifically addressed by professionals. A series of groups for the parents of pre-school children with severe disabilities are described. The groups are designed to provide parents with an opportunity to discuss in depth the impact of their childs' disability upon themselves, their partners and their families. Feedback from group members is reported and the practical issues in providing such groups discussed.