Clinical trial NCT06509360: How do You Feelee? Emotion-based Smartphone App in the Forensic Outpatient Setting
Official title: How do You Feelee? Does an Ordinary Question a Day Supports Youth in a Forensic Outpatient Setting to Become More Emotional Balanced? A Multiple Case Experimental Design
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Emotion Regulation
Emotional Neglect
Keywords: Smartphone data
Emoji
Emotion regulation
Adolescents
Forensic outpatient care
Lead sponsor: Amsterdam UMC, location VUmc
Sponsor class: OTHER
Collaborators: name: Levvel
name: Arkin
name: KFZ-J
First posted: 2024-07-19
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single Case Experimental Design
Primary purpose: SUPPORTIVE_CARE

Brief summary: This intervention study aims to explore the addition of the Feelee app (using active emoji data with passive behavioral data through phone sensing) in treatment as usual for adolescents in the forensic outpatient setting.

Participants will use Feelee for 4 weeks, which means specifying an emoji each day and collecting the passive data on the background. The collected active and passive data will be discussed through the clinicians during the participants' weekly treatment sessions.

Detailed description: Participants will be subjected to a ABA baseline design: including a 2-weeks baseline phase (A), 4-weeks intervention phase (B) and 2-weeks follow-up phase.

During the baseline phase (A), participants will fill in a daily questionnaire that measures different aspects of their emotion regulation skills. The use of the Feelee app is not allowed yet. After 2-weeks, the intervention phase starts, meaning participants will use the Feelee app every day during a 4-weeks period. The use of the Feelee app includes specifying an emoji and collecting the passive data on the background. Furthermore, the collected active and passive data will be discussed through the clinicians during the participants weekly treatment sessions. Participants will also be continuing to complete the daily questionnaire. After 4-weeks, the follow-up phase starts. Participants need to remove the Feelee app and will follow their treatment as usual. However, participants still need to complete the daily questionnaire. After 2-weeks the follow-up phase and main study part has ended.

Throughout the ABA baseline, pre-measurement (T0), post-measurement (T1) follow-up measurement (Tf1) will be conducted before and after the intervention and during follow-up. Last, a 3-months follow-up will be conducted to identify possible long-term effects.

Eligibility criteria: Inclusion Criteria:

* At the time of the study in treatment at a forensic outreach youth care organization.
* Expected to be in treatment for at least another 3 months.
* Using a smartphone with Android or IOS operating system.
* Have basic understanding about the use of a smartphone

Exclusion Criteria:

* Adolescents with serious psychiatric problems, such as psychosis or high risk of suicide
* Insufficient understanding of spoken and written Dutch language.
* Adolescents without a smartphone.

Primary outcomes:
measure: Emotion regulation: measured by a composite of items from the Difficulties in Emotional Dysregulation Scale (DERS-36) and Regulation of Emotion Systems Survey for daily usage (RESS-EMA)
timeFrame: Daily questionnaire (24 hour interval). From Day 0 (Week 1) up to Day 56 (Week 8).
Secondary outcomes:
measure: Emotional differentiation: Positive and Negative Affect Schedule (PANAS)
timeFrame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8
measure: Self-reflection: Self-Reflection and Insight Scale for Youth (SRIS-Y)
timeFrame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
measure: Emotional awareness: Emotional awareness subscale of the Multidimensional Assessment of Interoceptive Awareness (MAIA)
timeFrame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
Other outcomes:
measure: Motivation for treatment: Dutch Adolescent Treatment Motivation Questionnaire (ATMQ)
timeFrame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
measure: Treatment alliance: Dutch translation of the Working Alliance Inventory (WAV-12)
timeFrame: Pre-measurement (T0) at Week 1, post-measurement (T1) at Week 6 and follow-up-measurement at Week 8.
measure: Evaluation smartphone usage in treatment: the TWente Engagement with E-health Technologies Scales (TWEETS)
timeFrame: Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)
measure: Evaluation usability Feelee app: The System Usability Scale (SUS)
timeFrame: Follow-up measurement (Tf1) at Week 8 and 3 months follow-up measurement (Tf2) at Week 21 (3 months after Tf1)
Locations:
city: Amsterdam
country: Netherlands
facility: Inforsa
state: Noord-Holland
city: Amsterdam
country: Netherlands
facility: Levvel
state: Noord-Holland
Study officials:
affiliation: Amsterdam UMC, location VUmc
name: Arne Popma, Prof. dr.
role: PRINCIPAL_INVESTIGATOR
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