Objective This study aimed to conduct a randomised pilot trial to assess the feasibility of a randomised controlled trial (RCT) to investigate the effect of telephone-guided self-help for the treatment of mental health difficulties in children with neurological conditions.
Design Preliminary RCT. The primary outcome measure was the Strengths and Difficulties Questionnaire.
Setting Neurology clinics in a national tertiary paediatric hospital.
Patients Young people attending neurology clinics who met criteria for mental health difficulties according to the Development and Wellbeing Assessment.
Interventions 12 weeks of telephone-guided self-help based on a modular approach to psychological therapy for children delivered to children and/or their parents (n=17; eight males; mean age 12.04 years, SD=3.34) or a waiting list for telephone-guided self-help with no additional intervention over 12 weeks (n=17; nine males; mean age 10.53 years, SD=3.14).
Results 124 participants completed the DAWBA, and 34 children and young people were entered into the trial. 65% of those randomised to the intervention arm completed the full intervention, and the intervention was acceptable to those completing it. However, there were significant problems related to lack of data completion (38% data loss for primary outcome measure), choice of control comparator and outcome measures. Due to significant loss of data at follow-up, the effect size findings are considered unreliable.
Conclusions Further feasibility work should be conducted to improve data completeness before progression to a definitive trial of guided self-help for mental health problems in children with neurological conditions can be recommended.
Trial registration number ISRCTN21184717.
- child psychiatry
- general paediatrics
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Collaborators Epilepsy and Mental Health Programme Development Grant Research Group: Marta Buszewicz; Sarah Byford; Caroline Dore; Peter Fonagy; Tamsin Ford; Rona Moss-Morris; Susan Tebbs; and Erin Walker.
Contributors SB was a study coinvestigator, the project management lead, was the therapist for majority of patients and wrote the first draft of the manuscript for publication. IH was the joint lead coapplicant and Great Ormond Street Hospital psychiatric and clinical lead, designed the study and supervised DAWBA ratings. AEC was a study coinvestigator, contributed to the overall design of the study and rated all DAWBAs. SV was a study coinvestigator, was the neurology lead and supported study management in the neurology clinics. TS was a study coinvestigator, paediatric consultant and contributed to study design. RS was the joint lead coapplicant, designed the study, was therapist for some patients and supervisor of therapy for all and supervised the management of the study. The Mental Health in Children with Epilepsy study team provided advice regarding data interpretation and publication. SB and RS had complete access to the study data that support the publication.
Funding This work was funded by the Great Ormond Street Hospital Children’s Charity (Grant Number 17663). The research was supported by the National Institute for Health Research Biomedical Research Centre at Great Ormond Street Hospital for Children NHS Foundation Trust and University College London.
Disclaimer The views expressed are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests None declared.
Patient consent for publication Not required.
Ethics approval The study received ethical approval from the Camden and Islington Research Ethics Committee (registration number 14.LO.1353).
Data availability statement Data are available from the corresponding author on reasonable request.
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