Wellbeing in children with neurological conditions

ISRCTN	ISRCTN21184717
DOI	https://doi.org/10.1186/ISRCTN21184717
Secondary identifying numbers	13BS22

Submission date: 09/06/2015
Registration date: 25/09/2015
Last edited: 23/08/2022

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Mental and Behavioural Disorders

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Children with neurological conditions such as epilepsy are significantly more likely to develop mental health difficulties, such as anxiety, depression and behavioural problems than children who do not have neurological conditions. These mental health difficulties can have as big an impact upon quality of life and functioning as the neurological condition itself. There are highly effective treatments for anxiety, depression and behavioural difficulties in children. These include self-help interventions with guidance from a therapist. However, there has been little research to determine whether these interventions work in children who have a neurological condition.
The aim of this study is to assess whether they work in children with neurological conditions and also help us to design a larger scale study. If the results suggest that they do work, then we hope that local child and adolescent mental health services, as well as paediatric services, will be able to offer integrated, affordable, accessible, effective interventions for children with neurological conditions and mental health problems.

Who can participate?
Young people aged 7-18 years old with a neurological condition and waiting for/undergoing assessment/treatment at Great Ormond Street Hospital, London.

What does the study involve?
Participants are randomly allocated to one of two groups: receiving a 10-session guided self-help cognitive behavioural intervention delivered over the telephone over 12 weeks or being in the waiting list group (before receiving the self help intervention).

What are the possible benefits and risks of participating?
We cannot guarantee that the study will help individual families, but the information will help improve the treatment of children with anxiety, low mood or behavioural problems in the context of a neurological illness. There are no specific risks from taking part. The study is a ‘randomised waiting-list controlled study’, which means that a child might not be put into the group that receives the guided self-help intervention that we are testing straight away. However, these participants will still receive the intervention after 12 weeks. If we think that a child needs to meet with someone to discuss their wellbeing sooner (for example if their mood worsens considerably during this time), then we will refer them to other services that can help. No children will be deprived of an intervention that they would otherwise have received had they not been a part of the study. It is possible that thinking about their life and the effect of having a neurological condition could be upsetting for parents and/or their child. If the questionnaires do cause any distress, we can offer support and think about what further help is needed, including referral to other services if necessary.

Where is the study run from?
Great Ormond Street Hospital, London (UK).

When is the study starting and how long is it expected to run for?
October 2014 to October 2017.

Who is funding the study?
Institute of Child Health, University College London and Great Ormond Street Hospital charity, London (UK)

Who is the main contact?
Dr Sophie Bennett
sophie.bennett.10@ucl.ac.uk

Contact information

Dr Sophie Bennett
Public

UCL Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom

ORCID ID	0000-0002-1076-7112
Phone	+44 (0)20 7905 2232
Email	sophie.bennett.10@ucl.ac.uk

Study information

Study design	Feasibility study. Randomised controlled intervention trial comparing a guided self-help intervention with a waiting list control group.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Guided self-help interventions for psychiatric disorders in children and young people with neurological conditions: a feasibility study assessing symptom improvement on standardised questionnaire measures and a diagnostic screening instrument
Study objectives	A guided self-help treatment for common mental health disorders will be feasible and effective in reducing symptoms of anxiety, depression and/or disruptive behaviour in children and young people who have neurological conditions.
Ethics approval(s)	Camden and Islington NRES Committee, London, 09/10/2014, ref: 14/LO/1353
Health condition(s) or problem(s) studied	Mental health disorders (anxiety, depression and disruptive behaviour) in children and young people with neurological conditions.
Intervention	Intervention arm: a 10-session guided self-help cognitive behavioural intervention delivered over the telephone over 12 weeks Comparator: 12-week waiting list
Intervention type	Behavioural
Primary outcome measure	1. Primary mental health outcome: Strengths and Difficulties Questionnaire (SDQ) total score post-intervention and follow-up (weeks 12 and 24) 2. Primary physical health outcome measure: Paediatric Quality of Life Generic Core Scales (weeks 12 and 24)
Secondary outcome measures	1. Revised Child Anxiety and Depression Scale (12 weeks and 24 weeks) 2. Development and Wellbeing Assessment (12 weeks and 24 weeks)
Overall study start date	01/10/2014
Completion date	01/10/2017

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	40
Total final enrolment	34
Key inclusion criteria	1. Young people aged 7-18 years 2. With a neurological condition and waiting for/undergoing assessment/treatment at Great Ormond Street Hospital 3. Identified by the DAWBA as meeting criteria for impairing common psychiatric symptoms (anxiety, depression or disruptive behaviour)
Key exclusion criteria	1. Children/families who do not speak/understand English sufficiently well to access the screening assessments and interventions. This is primarily due to limited funding capacity for interpreters, however should sufficient additional funding be obtained, then we would seek to recruit these families and to hire interpreters to allow equitable access to the intervention. 2. Children who have an intellectual disability at a level meaning that they cannot access the screening and/or intervention. This will be determined by clinical judgement, either prior to screening, if the child is already known to GOSH, or at the initial assessment for guided self-help. This will not be defined by IQ, but by clinical judgement; children will not be excluded because of the presence of an LD per se, but because of being unable to access the materials. People will not be excluded post-testing on the basis of IQ score. Ability to participate may be different for younger children with relatively low IQs, whose parents complete the materials, compared to older children with the same IQ level who need to complete the materials themselves. If the learning disability is identified during the initial assessment (through clinical judgement), young people will be referred to other more appropriate services, as necessary (with the agreement of the family). 3.In phases 2 and 3, children who screen for a severe mental health disorder other than depression, anxiety or disruptive behavioural disorders, or whose screening is otherwise suggestive of risk will be excluded and referred to other services as appropriate. The research team comprises of a number of trained clinicians, who will be well-placed to liaise with, and refer to, other services. This may include (although is not restricted to) local CAMHS, the GOSH Psychological Medicine Team or paediatric psychology. This procedure will also be followed should it become apparent that there is risk, or a requirement for a higher intensity intervention, during the course of guided self-help. Consistent with best practice guidance (e.g. Department of Health, 2007) if the risk is immediate and requires urgent assessment or higher intensity intervention, then children will be referred on as necessary. Liaison will continue until the risk is adequately managed.
Date of first enrolment	01/04/2015
Date of final enrolment	01/11/2016

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Great Ormond Street Hospital for Children

London
WC1N 3JH
United Kingdom

Sponsor information

Great Ormond Street Hospital for Children NHS Foundation Trust
Hospital/treatment centre

Joint Research and Development Office
Great Ormond Street Hospital for Children NHS Foundation Trust
UCL Institute of Child Health
30 Guilford Street
Bloomsbury
London
WC1N 1EH
England
United Kingdom

"ROR"	https://ror.org/03zydm450

Funders

Funder type

Research organisation

Institute of Child Health, University College London
Private sector organisation / Universities (academic only)

Alternative name(s): UCL Great Ormond Street Institute of Child Health, GOS ICH
Location: United Kingdom

Great Ormond Street Hospital Charity
Private sector organisation / Other non-profit organizations

Alternative name(s): Great Ormond Street Hospital Children's Charity, GOSH Charity, GOSH
Location: United Kingdom

Results and Publications

Intention to publish date	31/12/2018
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan	Following completion of the study in 2017, we will disseminate the findings in a variety of ways including: • Publication in peer-reviewed scientific journals • Presentations at relevant national and interventional conferences • Publication on our research-group website • Stakeholder Meeting: We will hold a Research Update meeting for participants, stakeholders and non-scientific audiences with PPI involvement
IPD sharing plan	Individual participant level data will not be made available as it may identify participants with rare conditions. Data will be held at Great Ormond Street Hospital for Children NHS Foundation Trust.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/07/2018	21/06/2019	Yes	No
Results article	results	05/01/2021	12/01/2021	Yes	No
Protocol article		04/11/2016	23/08/2022	Yes	No
HRA research summary			28/06/2023	No	No

Editorial Notes

23/08/2022: Publication reference added.
12/01/2021: Publication reference added.
25/06/2019: IPD sharing statement added.
21/06/2019: Publication reference and total final enrolment number added.