The goal is to develop and research the smartphone app intervention to adolescents with a chronic medical condition 1) to offer an intervention with attractive and fun challenges to increase their emotional resilience and2) to identify emotional…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
luchtweg-, maagdarmstelselontstekings-, hart-, nier-, lever-, huid-, oor-, bloed-, skeletspierstelselaandoeningen, auto-immuunziekten, chronische pijn, chirurgische verrichtingen
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome measures are anxiety and depressive symptoms immediately
after playing the app (T2) and coping. Anxiety is measured with the anxiety
subscale of the Hospital Anxiety and Depression Scale (HADS) and depressive
symptoms with the Children Depression Inventory (CDI). Coping is measured daily
by ESM with questions based on the FEEL-KJ, ERQ, CERQ and UCL. Thereby,
participants will be categorized into three different mood profiles (*happy*,
*typically developing*, and *at risk for depression*) based on ESM, to help
disentangling *at risk* adolescents from *typically developing* teens regarding
risk of depression.
Secondary outcome
Secondary outcomes are:
Questionnaires:
- Anxiety and depressive symptoms of the adolescent before playing the app (T1)
and 3 months after finishing the app (T3 and T5).
- Coping
- Quality of life
- Emotional and behavioral problems
- Self-esteem
- Illness perception
ESM measures:
- Sleep quality and quantity
- Negative and positive affect
- Fatigue
- Loneliness
- Worry
- Physical pain
- Exercise
- Coping
- Health status
- Medication adherence
Background summary
Many adolescents are treated in the Sophia Children's Hospital for a chronic
somatic condition. A large proportion of them (35-40%) have severe emotional
problems such as anxiety, depression and post-traumatic stress symptoms as a
result of the chronic somatic condition. Because of these emotional problems,
they have lower quality of life, they function less well at school, they
withdraw from social contacts and they show less adherence to therapy. Their
parents also often experience psychosocial problems as a result. Despite these
alarming results, emotional problems are often unrecognized and untreated. This
leads to long-term unnoticed suffering and shame.
Children's hospitals do not screen for emotional problems by default. For
adolescents with a chronic medical condition, the threshold is often high to
report that they have emotional problems, such as fear or sadness. Nor are
there any valid tools to screen for emotional problems quickly and
cost-effectively. An innovative smartphone application (mHealth) is developed
together with eight departments of the Sophia Children's Hospital. Smartphone
monitoring of emotions is extremely suitable, because adolescents are strongly
inclined to use a fun and challenging app.
Study objective
The goal is to develop and research the smartphone app intervention to
adolescents with a chronic medical condition
1) to offer an intervention with attractive and fun challenges to increase
their emotional resilience and
2) to identify emotional problems based on the Experience Sampling Method
(ESM).
Study design
Parallel-group randomized controlled study (RCT) with a psychosocial
intervention group and a wait-list control group. The waiting list condition
also receives the psychosocial intervention after three months.
There will be three measurements for the intervention group:
T1 = measurement of (online) questionnaires prior to smartphone serious game
intervention
T2 = measurement of (online) questionnaires immediately after completion of
smartphone serious game intervention
T3 = measurement of (online) questionnaires 3 months after completion of
smartphone serious game intervention
There will be five measurements for the wait-list control group:
T1 = measurement of (online) questionnaires simultaneously with T1 of the
intervention group
T2 = measurement of (online) questionnaires simultaneously with T2 of the
intervention group
T3 = measurement of (online) questionnaires prior to smartphone serious game
intervention
T4 = measurement of (online) questionnaires immediately after completion of
smartphone serious game intervention
T5 = measurement of (online) questionnaires 3 months after completion of
smartphone serious game intervention
Intervention
Both groups receive the smartphone application Grow it! as an intervention. The
intervention consists of challenges aimed at activation, changing from a
passive to an adaptive coping style and having positive experiences.
Study burden and risks
The risks associated with participation are negligible and the burden is
minimal.
Risks: not applicable
Burden: Filling in a micro-questionnaire 5 times a day for 4 weeks (1 to 2
minutes at a time). This may be perceived as somewhat onerous by some
adolescents. A large number of questionnaires are administered to the
adolescents and their parents at T1, T2, T3, and possibly T4 and T5. It has
been ensured that the burden is minimal by keeping the number of online
questionnaires and ESM micro-questions as short as possible. Furthermore, all
measurements will take place online so that adolescents and parents do not have
to visit the Sophia Children's Hospital.
The research aims to research the effectiveness of the Grow It! app among
adolescents with a chronic medical condition and is therefore group-bound.
Wytemaweg 8
Rotterdam 3015 CN
NL
Wytemaweg 8
Rotterdam 3015 CN
NL
Listed location countries
Age
Inclusion criteria
Adolescents (10-18 years) with a chronic somatic condition, i.e. a condition
which 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 (Van Hal et al.,
2019), receiving treatment or routine examinations/checkups at the Erasmus
MC-Sophia Children*s hospital.
Exclusion criteria
* Intellectual disability (IQ < 70) * Insufficient comprehension and
proficiency of the Dutch language
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL75678.078.21 |