Clinical trial NCT05795803: Effects of COVID-19 Forced Isolation Context on Adolescents With and Without Somatic Symptom Disorder
Official title: Effects of a Pandemic Forced Isolation Context on Adolescents With Somatic Symptom Disorder. A Panel Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Somatic Symptom Disorder
Keywords: SSD
adolescents
coping strategies
social media
Lead sponsor: IRCCS Burlo Garofolo
Sponsor class: OTHER
First posted: 2023-04-03
Enrollment: 115
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: * SSD group: Adolescents who received a diagnosis of SSD at the Institute for maternal and child health "Burlo Garofolo"
* Without SSD group: Adolescents who accessed the Emergency Department for traumatic injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because of food allergies.

Brief summary: The purpose of this study is to evaluate whether a forced isolation context (such provided by the ongoing Covid-19 pandemic restrictive measures) could reduce the burden of somatic symptoms among a group of patients with Somatic Symptom Disorder (SSD). Secondary objective is to assess if a reduction in terms of depression tendency and anxiety occurs in this specific population and which are the effect of such a context among a group of adolescents without SSD. We want to compare these results with data obtained at the end of the pandemic.

Detailed description: This study aims to evaluate whether the forced isolation context provided by the ongoing Covid-19 pandemic is providing an advantage in terms of reduction of somatic symptoms burden among an Italian group of adolescents with SSD, assessed by the Patient Health Questionnaire (PhQ15) administered during and at the end of the pandemic.

Secondary objectives of the study are:

* To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of SSD adolescents, during and after the pandemic isolation context.
* To investigate the difference in anxiety and depression scores assessed by the Multidimensional Anxiety Scale for Children (MASC2) and Child Development Inventory (CDI-2) questionnaires among a group of adolescents without SSD, during and after the pandemic isolation context.
* To compare the difference in anxiety and depression scores time modification between the two groups of adolescents.
* To explore through tailored questions which adolescents' coping strategies are during a pandemic isolation context among SSD patients and a group of controls without SSD.

Eligibility criteria: Inclusion Criteria:

* Adolescents aged between 12 and 17 years old who received a diagnosis of SSD within the last six months or before unless assessed and confirmed by a specialist within the last six months
* Adolescents without a diagnosis of SSD, who previously accessed the Institute for maternal and child health "Burlo Garofolo" Emergency Department for traumatic injuries or the Pediatric Clinic/Day Hospital Service for oral immunotherapy because of food allergies.
* Adolescents experiencing a quarantine period during the Covid19 pandemic.

Exclusion Criteria:

* Adolescents with cognitive impairment.
* Adolescents with chronic diseases.
* Adolescents with other neuropsychiatric disorders according to the fifth edition of the Diagnostic and Statistical Manual of Mental Disorder (DSM V).
* For the group without SSD diagnosis, any access to Emergency Department for unexplained chronic pain or any history of other psychiatric comorbidities.

Primary outcomes:
measure: Difference in mean PhQ15 scale scores between T0 and T1 in the SSD adolescents group.
timeFrame: During the pandemic and within 6 months after the end
Secondary outcomes:
measure: Difference in mean MASC2 scores between T0 and T1 in the SSD group.
timeFrame: During the pandemic and within 6 months after the end
measure: Difference in mean CDI-2 short questionnaire scores between T0 and T1 in the SSD group.
timeFrame: During the pandemic and within 6 months after the end
measure: Difference in mean MASC2 scores between T0 and T1 in the adolescents group without SSD diagnosis.
timeFrame: During the pandemic and within 6 months after the end
measure: Difference in mean CDI-2 short questionnaires scores between T0 and T1 in the adolescents group without SSD diagnosis.
timeFrame: During the pandemic and within 6 months after the end
measure: Comparison between the two groups of adolescents in the mean T1-T0 differences for MASC2 scores.
timeFrame: During the pandemic and within 6 months after the end
measure: Comparison between the two groups of adolescents in the mean T1-T0 differences for CDI-2 short questionnaires scores.
timeFrame: During the pandemic and within 6 months after the end
measure: Description of adolescents' coping strategies during a pandemic isolation context among SSD and non-SSD adolescent
timeFrame: During the pandemic
Other outcomes:
Locations:
city: Trieste
country: Italy
facility: Institute for Maternal and Child Health - IRCCS Burlo Garofolo-
Study officials:
affiliation: Institute for maternal and child health Burlo Garofolo
name: Giuseppe Abbracciavento, MD
role: STUDY_CHAIR
affiliation: Institute for maternal and child health Burlo Garofolo
name: Laura De Nardi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for maternal and child health Burlo Garofolo
name: Andrea Trombetta, MD
role: PRINCIPAL_INVESTIGATOR
References: