Guided self-help treatment for children and young people with eating disorders: a case series
| ISRCTN | ISRCTN16038125 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16038125 |
| IRAS number | 323971 |
| Secondary identifying numbers | 23PP09, IRAS 323971 |
- Submission date
- 03/10/2023
- Registration date
- 04/10/2023
- Last edited
- 15/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Eating disorders are common and serious mental health conditions that typically begin in adolescence. There are some effective psychological treatments for eating disorders in children and young people, including family-based therapy and cognitive behavioural therapy. However, these treatments are costly and time-consuming, and the demand for treatment far outweighs the availability of resources. One way to increase access to psychological support for children and young people with disordered eating would be to develop a guided self-help intervention, which is brief and requires less therapist time/input than traditional psychological treatments. The National Institute for Health and Care Excellence (NICE) recommend guided self-help interventions for adults with bulimia nervosa and binge eating disorder. They are also widely used in the treatment of anxiety disorders, depression and behavioural difficulties in children and young people. However, child and adolescent eating disorder services in the UK do not routinely use guided self-help interventions as they have not been sufficiently researched. The overarching aim of this project is to improve access to psychological treatments for children and young people affected by disordered eating. Specifically, this preliminary study aims to examine the feasibility, acceptability and preliminary effectiveness of a guided self-help intervention for children and young people (aged 8-19 years) with impairing symptoms of disordered eating using a case series design.
Who can participate?
Children and young people (aged 8-19) with impairing symptoms of disordered eating, and their parents/carers.
What does the study involve?
The study involves a battery of questionnaires to assess the presence or absence of eating disorder symptoms. Depending on clinical need, young people and their families will receive a CBT-guided self-help intervention, with 8 x 30-minute sessions with a guide. Families are asked to complete standardised questionnaires at baseline and 12-week follow-up. Families are also asked to complete weekly questionnaires throughout the intervention.
What are the possible benefits and risks of participating?
The project aims to benefit young people's mental health and improve access to psychological support. The research team do not foresee any risks in taking part but answering some of the baseline and follow-up questionnaires may cause some emotional distress.
Where is the study run from?
The study is run by UCL Great Ormond Street Institute of Child Health (UK) and is open to multiple eating disorder services across the UK.
When is the study starting and how long is it expected to run for?
January 2023 to July 2024
Who is funding the study?
This study is funded by a Child Health Research PhD studentship at UCL Great Ormond Street Institute of Child Health (UK)
Who is the main contact?
Emily Davey, emily.davey.21@ucl.ac.uk (UK)
Contact information
Principal Investigator
UCL Great Ormond Street Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
 ORCID ID |
0000-0003-2729-4961 |
|---|---|
| Phone | +44 (0)20 7905 2700 |
| r.shafran@ucl.ac.uk |
Public, Scientific
UCL Great Ormond Street Institute of Child Health
30 Guilford Street
London
WC1N 1EH
United Kingdom
| ORCID ID |
0000-0001-5785-1533 |
|---|---|
| Phone | +44 (0)20 7905 2700 |
| emily.davey.21@ucl.ac.uk |
Study information
| Study design | Single-arm non-randomized case series |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Community, Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Guided self-help treatment for children and young people with eating disorders: a case series |
| Study hypothesis | The hypothesis is that guided self-help will be feasible and acceptable to children and young people with impairing symptoms of disordered eating. |
| Ethics approval(s) |
Approved 26/06/2023, West of Scotland Research Ethics Committee 5 (Ward 11, Dykebar Hospital, Grahamston Road, Paisley, PA2 7DE, United Kingdom; +44 (0)141 314 0213; WoSREC5@ggc.scot.nhs.uk), ref: 23/WS/0097 |
| Condition | Psychological intervention for children and young people with impairing symptoms of disordered eating. |
| Intervention | This is a single-arm trial with no control group. Referral methods: Specialist child and adolescent eating disorder services have been identified as research sites for this project. Participants will be referred by their clinician, who, after gaining families' consent to contact, can share their details with the study team. The study team will then contact the family with more information and details for the next steps and consent process. Observations for all groups: All participants will fill out baseline measures after consenting to be part of the study. Baseline measures include the Eating Disorder Examination Questionnaire (EDE-Q), the Clinical Impairment Assessment (CIA), %Weight-for-height, the Revised Child Anxiety and Depression Scale (RCADS) and the Strengths and Difficulties Questionnaire (SDQ). Following this, all eligible families will be offered a cognitive behavioural therapy (CBT), guided self-help intervention. The intervention consists of 8 modules with 8 x 30-minute support sessions with a guide. The core aims of the intervention are to provide psychoeducational material provided as part of the cognitive-behavioural treatment of eating disorders for children and young people and to encourage young people to change a variety of thoughts and behaviours relating to eating, body weight and body shape. Participants will be asked to read the relevant module of the programme before each session, and will also be asked to complete some activities between each session. Participants will complete weekly questionnaires throughout the intervention to assess week-to-week changes. Session-by-session measures include the Eating Disorder-15 for Youth (ED-15-Y), Goal Based Outcomes (GBOs), the Outcome Rating Scale (ORS) and the Strengths and Difficulties Questionnaire Session by Session (SDS SxS). Follow-up for all groups: All participants will complete follow-up questionnaires, 12 weeks after completing their baseline questionnaires. This includes the Eating Disorder Examination Questionnaire (EDE-Q), the Clinical Impairment Assessment (CIA), %Weight-for-height, the Revised Child Anxiety and Depression Scale (RCADS) and the Strengths and Difficulties Questionnaire (SDQ). Participants will also be asked to complete an acceptability questionnaire and will be invited to take part in an optional interview to explore their experiences of receiving the intervention. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported eating disorder symptoms measured using the global score on the Eating Disorder Examination Questionnaire (EDE-Q) at baseline and 12-week follow-up. |
| Secondary outcome measures | 1. Self-reported psychosocial impairment due to eating disorder symptoms measured using the Clinical Impairment Assessment (CIA) at baseline and 12-week follow-up 2. Self-reported %Weight-for-height at baseline and 12-week follow-up 3. Self-reported and parent-reported anxiety and depression symptoms measured using the Revised Child Anxiety and Depression Scale (RCADS) at baseline and 12-week follow-up 4. Self-reported and parent-reported psychological well-being measured using the Strengths and Difficulties Questionnaire (SDQ) at baseline and 12-week follow-up 5. Self-reported and parent-reported acceptability ratings measured using an acceptability questionnaire |
| Overall study start date | 16/01/2023 |
| Overall study end date | 05/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 8 Years |
| Upper age limit | 19 Years |
| Sex | Both |
| Target number of participants | 10 |
| Participant inclusion criteria | 1. Aged 8-19 years 2. Has a threshold or sub-threshold eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder and otherwise specified feeding and eating disorder [OSFED]) which impairs their psychosocial functioning 3. Is a UK resident 4. Has a parent/carer who is also willing to take part in the study |
| Participant exclusion criteria | 1. Does not speak/understand English sufficiently well to access the measures and intervention materials 2. Has an intellectual disability at a level meaning that they cannot access the measures and/or intervention 3. Acute risk not considered suitable for the trial due to the clinical need for specialist intervention, e.g., rapid weight loss, very low mood, high medical or psychiatric risk, acute suicidality, recurrent or potentially life-limiting self-harm and/or significant safeguarding concerns 4. If they have been prescribed psychotropic medication, the dosage must have been stable for the past two months 5. Currently receiving other overlapping psychological support/interventions 6. Does not have access to a telephone or laptop/computer which can be used for the interviews and guidance sessions |
| Recruitment start date | 16/10/2023 |
| Recruitment end date | 31/03/2024 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centres
St Pauls Medical Complex
Swindon Road
Cheltenham
GL51 9EZ
United Kingdom
Maudsley Hospital
De Crespigny Park
London
SE5 8AZ
United Kingdom
Sponsor information
University/education
UCL Great Ormond Street Institute of Child Health
30 Guilford Street
London
WC1N 1EH
England
United Kingdom
| Phone | +44 (0)20 7905 2700 |
|---|---|
| research.governance@gosh.nhs.uk | |
| Website | https://www.gosh.nhs.uk/our-research/contact-us-rd-team/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Charity
No information available
Results and Publications
| Intention to publish date | 01/06/2025 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data sharing plans for the current study are unknown and will be made available at a later date |
Editorial Notes
15/10/2024: The overall end date was changed from 01/10/2024 to 05/07/2024.
04/10/2023: Study's existence confirmed by West of Scotland Research Ethics Committee 5 (UK).
