Grow It! Sophia: investigating the Grow It! smartphone app used to identify mood problems and promote adaptive coping in adolescents with a chronic somatic condition
| ISRCTN | ISRCTN17883961 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17883961 |
| Secondary identifying numbers | NL75678.078.21 |
- Submission date
- 25/04/2022
- Registration date
- 27/06/2022
- Last edited
- 15/03/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
A chronic somatic condition is defined as a condition that lasts longer than 3 months, recurs more than three times a year and/or is related to long-term use of medication, treatments or help. Youth with chronic somatic conditions are at increased risk of anxiety and depression. Recent studies have indicated that 34-40% of adolescents with a chronic somatic condition experience significant levels of anxiety and depression, which is far more than in their healthy peers. A sharp increase in the prevalence of emotional problems is typically seen in adolescence. Such problems are related to social and academic impairments and reduced quality of life, as well as non-compliance with medical treatment recommendations, poor health, and an increase in medical costs by up to 50%. The aim of this study is to study a serious gaming application (Grow It! App) by:
1. Testing the effect of a psychosocial intervention aimed at promoting adaptive coping in adolescents with a chronic somatic condition
2. Examining the acceptance and effectiveness of the Grow It! smartphone application as a method of obtaining insights into the daily emotions and behavior of adolescents with a chronic somatic condition
3. Examining demographic and illness-related factors that predict or are associated with the effect of the psychosocial intervention.
Who can participate?
Children between 10 and 18 years, treated in the Erasmus MC- Sophia Kinderziekenhuis for a chronic somatic condition
What does the study involve?
Children will be randomly allocated to the intervention group (to use the app straight away for 4 weeks) or the control group (a waiting list period, starting using the app 4 months later). Anxiety and depression are measured at the start of the study, after using the app (week 5), and after 3 months.
What are the possible benefits and risks of participating?
The benefits for the adolescents are gaining more insight into their emotions, identifying problems more quickly and strengthening emotional resilience by completing challenges aimed at adaptive coping. The smartphone application also promotes self-reflection and being more physically active. There are no risks involved with participating in this study.
Where is the study run from?
Sophia Children's Hospital Rotterdam (Netherlands)
When is the study starting and how long it is expected to run for?
September 2020 to July 2024
Who is funding the study?
Erasmus Universitair Medisch Centrum Rotterdam (Netherlands)
Who is the main contact?
Dr Jeroen Legerstee
j.s.legerstee@erasmusmc.nl
Contact information
Principal Investigator
Dr. Molenwaterplein 40
Rotterdam
3015GD
Netherlands
| Phone | +31 (0)631145085 |
|---|---|
| growitsophia@erasmusmc.nl |
Study information
| Study design | Parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | 41625_PIS_12to16years_18Feb22.pdf |
| Scientific title | Grow It! Sophia: a smartphone application to identify mood problems and adaptive coping in adolescents with a chronic somatic condition |
| Study acronym | Grow It! Sophia |
| Study objectives | Recent studies have indicated that 34-40% of adolescents with a chronic somatic condition experience significant levels of anxiety and depression. The aim of this study is to study a serious gaming smartphone application (GrowIt! App) by: 1. Testing the effect of a psychosocial intervention aimed at promoting adaptive coping in adolescents with a chronic somatic condition 2. Examining the acceptance and effectiveness of the GrowIt! smartphone application as a method of obtaining insights into the daily emotions and behaviour of adolescents with a chronic somatic condition 3. Examining demographic and illness-related factors that predict or are associated with the effect of the psychosocial intervention. |
| Ethics approval(s) | Approved 17/05/2021, Erasmus MC Research Ethics Committee (Postbus 2040, 3000 CA, Rotterdam, Netherlands; +31 (0)207034428; metc@erasmusmc.nl), ref: NL75678.078.21 |
| Health condition(s) or problem(s) studied | Chronic somatic condition |
| Intervention | Participants are allocated to the experimental or control condition through computer-based, block-wise randomisation. Patients are assigned to blocks based on their chronic somatic condition. Assessments are not blind to condition, because the researchers are not involved in any of the assessments, and only the children and adolescents fill out online questionnaires. Consequently, indications for breaking the randomisation code are not applicable. 1. Active condition: use of the Grow It! app for 4 weeks 2, Waiting list condition: online questionnaires, and after a period of approx. 4 months use of the Grow It! app for 4 weeks |
| Intervention type | Other |
| Primary outcome measure | Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS) and the Children Depression Inventory (CDI) at baseline, after using the app (week 5), after 3 months (condition group T4 and T5) |
| Secondary outcome measures | 1. Quality of life is measured using the Pediatric Quality of Life Inventory (PedsQL) Generic Core Scales at baseline, after 5 weeks and after 3 months (condition group T4 and T5) 2. Self-esteem is measured using the Rosenberg Self-Esteem Scale (RSES) at baseline, after 5 weeks and after 3 months (condition group T4 and T5) 3. Illness perception is measured using the Brief Illness Perception Questionnaire (B-IPQ) at baseline, after 5 weeks and after 3 months (condition group T4 and T5) 4. Emotional and behavioural problems are measured using the Child behaviour Checklist (CBCL) at baseline, after 5 weeks and after 3 months 5. Sleep quality and quantity are measured using a self-developed scale based on prior studies for 28 days once a day 6. Emotions are measured using a test based on the Positive and Negative Affect Schedule (PANAS) for 28 days, 5 times a day 7. Fatigue, loneliness and worry are measured using a self-developed scale based on prior studies for 28 days, 5 times a day 8. Physical pain is measured using the Numerical Rating Scale (NRS) for 28 days, 5 times a day 9. Events are measured using a self-developed scale based on prior studies for 28 days, 5 times a day 10. Coping is measured using a self-developed scale based on Fragebogen zur Erhebung der Emotionsregulation bei Kindern und Jugendlichen (FEEL-KJ), Emotion Regulation Questionnaire (ERQ), Cognitive Emotion Regulation Questionnaire (CERQ) and UCL for 28 days, once a day 11. Exercise questions are measured using a self-developed scale based on prior studies for 28 days, once a day 12. Medication adherence is measured using a self-developed question for 28 days, 5 times a day 13. Health status is measured using a self-developed scale for 28 days, 5 times a day |
| Overall study start date | 01/09/2020 |
| Completion date | 18/07/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | Both |
| Target number of participants | 200 |
| Key inclusion criteria | Adolescents (aged 10 - 18 years) undergoing treatment in the Sophia Children's Hospital Rotterdam for a chronic somatic condition (a condition that lasts longer than 3 months, recurs more than three times a year and/or is related to long-term use of medication, treatments or help) |
| Key exclusion criteria | 1. Intellectual disability (IQ <70) 2. Insufficient comprehension and proficiency of the Dutch language |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 06/10/2023 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Rotterdam
3015 CN
Netherlands
Sponsor information
Charity
Wytemaweg 80
Rotterdam
3015 CN
Netherlands
| Phone | +31 (0)10 703 67 50 |
|---|---|
| info@vriendensophia.nl | |
| Website | https://vriendensophia.nl/agenda/sprinting-sophia/ |
Funders
Funder type
Hospital/treatment centre
Government organisation / Local government
- Alternative name(s)
- Erasmus Universitair Medisch Centrum, Erasmus University Medical Center, Erasmus MC
- Location
- Netherlands
Results and Publications
| Intention to publish date | 01/11/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Planned publications in high-impact international journals. |
| IPD sharing plan | The datasets generated during and/or analyzed during the current study are not expected to be made available due to privacy of the participants |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Aged 12 to 16 years | 18/02/2022 | 19/05/2022 | No | Yes |
| Participant information sheet | Aged 16 to 18 years | 18/02/2022 | 19/05/2022 | No | Yes |
| Participant information sheet | Parents | 18/02/2022 | 19/05/2022 | No | Yes |
Additional files
- 41625_PIS_12to16years_18Feb22.pdf
- Aged 12 to 16 years
- 41625_PIS_16to18years_18Feb22.pdf
- Aged 16 to 18 years
- 41625_PIS_Parents_18Feb22.pdf
- Parents
Editorial Notes
15/03/2024: The following changes were made:
1. The overall study end date was changed from 18/06/2024 to 18/07/2024.
2. The intention to publish date was changed from 01/09/2023 to 01/11/2024.
19/09/2023: The following changes were made to the study record:
1. Ethics approval details added.
2. The recruitment end date was changed from 01/12/2022 to 06/10/2023.
3. The overall study end date was changed from 01/09/2023 to 18/06/2024.
19/05/2022: Trial's existence confirmed by the Erasmus MC Research Ethics Committee.
