An observational study in Somatic Symptom Disorder, sponsored by Meyer Children's Hospital IRCCS. Recruiting at 2 sites in Italy. Open to participants aged 11 Years to 17 Years. Per ClinicalTrials.gov, last updated 2025-09-26.
Sponsored by Meyer Children's Hospital IRCCS · Observational
To evaluate whether emotional awareness, attachment style and the ability to abstract and symbolize (IQ) influence the appearance of somatic symptoms. Hypothesis: the investigators expect the presence of somatic symptoms linked to the lower ability of emotional awareness, to lower ability to abstract and symbolize and to an insecure attachment style.
Somatic Symptom Disorder (eg pain, weakness, chronic fatigue) represents one of the main reasons why patients seek specialist medical advice. Although the symptoms often manifest themselves in a disabling form and there are numerous medical examinations to which patients undergo, these do not seem to find an organic confirmation to their problem and consequently the patients do not receive a specific diagnosis. These are usually transient symptoms but it can happen that they become persistent and chronic, going to constitute themselves as real somatic syndromes. The study investigates the psychological and family aspects that seem to characterize somatic and chronic pain symptoms in pediatric age. In addition to this objective, the study aims to quantify the health costs incurred in the diagnostic phase prior to the classification of the somatic symptom. These elements would make it possible to achieve greater knowledge of clinical pictures and the identification of useful markers for the clinician to make early diagnoses and guide patients in a global and timely care.
71 studies on the registry are indexed under Medically Unexplained Symptoms; 22 are open to participants now.
This study's planned enrollment of 300 is close to the median of 300 across 17 observational studies indexed under Medically Unexplained Symptoms.
Browse Medically Unexplained Symptoms studies →Meyer Children's Hospital IRCCS is the lead sponsor of 78 studies on the registry; 55 are open to participants now.
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The population under study is made up of pediatric patients (aged from 11 to 17), and an accompanying caregiver, belonging to the functional chronic pain clinic of Pain Therapy and Palliative Care, to the SOC of Gastroenterology and Nutrition, to the SOSA of Bronchopneumology and to the SOC of Medical Pediatrics as well as to the SOSA of Pediatric Hospital Psychology who present with somatic symptom disorders. All consecutive patients and accompanying caregivers who access the aforementioned services and who meet the expected inclusion criteria will be enrolled.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Caregiver exclusion criteria:
Control group population inclusion criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
DSM diagnostic criteria
The American Psychiatric Association’s manual of mental health diagnoses. DSM-5 (2013, revised as DSM-5-TR in 2022) replaced DSM-IV, and some studies still name the older edition. “Meets DSM criteria for …” means diagnosed by that edition’s diagnostic criteria, usually by a clinician in an interview.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The group is made up of pediatric patients, and an accompanying caregiver, belonging to the functional chronic pain clinic of Pain Therapy and Palliative Care, to the Gastroenterology and Nutrition Unit, to the Bronchopneumology Unit and Medical Pediatrics as well as to the Pediatric Psychology Unit, who present with somatic symptom disorders.
Other: psychological assessment
The population of the control group, recruited through informal channels according to a sampling of convenience, will be enrolled on the basis of the expected inclusion criteria.
Other: psychological assessment
The intervention consists in the assessment of some psychological aspects (emotional awareness, attachment style and the ability to abstract and symbolize (IQ)) of pediatric patients who present with somatic symptom disorders. , through specific tests. Each patient fills out the test battery during the psychological consult. At the same time, it is involved a parent to collect personal and clinical data through an ad hoc questionnaire.
Emotional awareness
Emotion Awareness Questionnaire - EAQ-30 (Rieffe et al., 2008; Camodeca \& Rieffe, 2013) The EAQ is a self-report test aimed at measuring the emotional awareness of children and adolescents, it is composed of 6 subscales and 30 items and has a Likert scale of 3 points. High scores obtained at the different subscales indicate a high emotional awareness. The cut offs are specific for age and sex, for the interpretation of the scores reference is made to the scores obtained by the control group in the study by Camodeca et al., 2013.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
attachment style
The Saparation Anxiety Test - SAT, Italian version adapted from Attili (2001) is a semi-projective tool aimed at measuring the attachment style of the child and adolescent, through the analysis of reactions and verbal responses to stimuli that illustrate 6 hypothetical situations of separation by parental figures. The responses are then classified into 8 categories which calculate a score that is compared with reference score ranges that correspond to 4 different attachment styles. Specifically, scores equal to or greater than 4 indicate secure attachment, scores between 3 and 1 an ambivalent insecure attachment, scores between 0 and -2 an avoidant insecure attachment, and finally scores equal to or lower than -3 are indicative of an attachment style disorganized / confused.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Ability to abstract and symbolize (IQ)
Raven's Standard Progressive Matrices - SPM-RA (Raven, 1982), are a test that aims to measure the general factor of fluid intelligence. the test consists of four series (A, B, C, D) of 12 items each of increasing complexity. It is an excellent test from both a psychometric and a factorial point of view. The updated report - SPM-RA (prepared by Picone, Orsini and Pezzuti) will be used as a reference for the test scoring, which allows the instrument to be used for a sample aged 6 to 18. An intelligence score above 25/36 indicates an above average intelligence level, scores between 17/36 and 25/36 are to be considered indicative of an average intelligence level, scores below 17/36 below average intelligence medium (Picone, Orsini and Pezzuti)
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Stressful life events
Codding Life Event Scales - CLES A (Coddington, 1972) (version A for individuals aged ≥ 13). The CLES is a self-report measure that helps determine how specific events have affected a child's personal growth and adjustment. Results identify areas that may require further investigation. The scales allow clinicians to easily identify actual and potential physical and mental health problems arising from psychological causalities. By measuring significant life events in terms of Life Change Units (LCUs), the CLES can provide insight into recent events that may be affecting the respondent's health. The CLES scales also take into account the different kinds of life challenges that are faced by children of different ages. There are three scales and the items included on each refer to events that children of the particular age group may have experienced. Each form produces a Life Change Unit score that is applied to Risk Evaluation cut-off guidelines.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Behavioral and emotional issues
The Child Behavior Checklist - CBCL / 6-18 is a self-report test aimed at parents of children aged 6 to 18, aimed at measuring, in addition to adaptive skills, eight syndromes: Anxiety / Depression, Withdrawal / Depression, Somatic complaints, Social problems, Thinking problems, Attention problems, Rule-breaking behavior, Aggressive behavior. These syndromes represent categories of problems that tend to be associated and are organized in two superordinate scales: scale of Internalization Problems and scale of Outsourcing Problems. The standard scores are scaled so that 50 is the average for age and gender, with an sd of 10 points. Higher scores indicate greater problems. Score located below the 93rd percentile are considered to be the average, scores between the 93-97th percentile are borderline and any score above the 97th percentile is within the clinical range.
Time frame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
stress and protection indicators
The Draw-a-Person-in-the-Rain Test (DAPR) is a projective test that theoretically creates a situation for projecting a symbolic image of oneself in a stressful environment (Hammer, 1958). It measures stress factors and defense ability by drawings of a person in the rain. The DAPR uses two rating scales: the first one hypothetically measures coping resources and rates various forms of protection against the rain (eg. hat, coat, shoes or boots, an umbrella, etc); the second scale hypothetically measures stress and includes features of the rain itself (eg. large raindrops, dense rain, puddles and clouds, etc.). In addition to the two scores, a Coping Balance index is derived by subtracting the number of stress indicators from the number of protective indicators. In theory, a person with more coping resources could manage higher levels of stress without being overwhelmed.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
pain coping strategies
The Waldron/Varni Pediatric Pain Coping Inventory (PPCI) was developed to be a standardized questionnaire to assess systematically children's pain coping strategies. The PPCI was administered to 187 children and adolescents experiencing musculoskeletal pain associated with rheumatologic diseases. A principal components analysis revealed a five-factor solution for the PPCI: (1) cognitive self-instruction, (2) seek social support, (3) strive to rest and be alone, (4) cognitive refocusing, and (5) problem-solving self-efficacy. The results of this research provide initial evidence that the PPCI is a conceptually valid and internally reliable measure for assessing pediatric pain coping strategies
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Demographic and health variables
Questionnaire addressed to the accompanying caregiver to collect demographic and disease data together with data on patient life events
Time frame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Perceived pain, duration and impact on life areas
Visual Analogue Scale - VAS (Scott, Ansell, \& Huskisson, 1977) standardized test for pain measurement in children over 7 years of age. The child is asked to indicate, on a numbered line, the point corresponding to the pain intensity they feel: the left extremity is marked with the label "no pain" and the right extremity with "the worst possible pain". The distance, expressed in centimeters, from the left end of the scale coincides with the evaluation.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Parental Reflective Functioning
The Parental Reflective Functioning Questionnaire (Luyten et al., 2017) consists of two versions: PRFQ and PRFQ-A.The PRFQ (valid. It Pazzagli et al., 2018) is an 18-item questionnaire for parents and children aged 3 to 11 that evaluates the parent's ability to recognize and understand the mental states that affect the child's behavior (Rutherford et al., 2013). It consists of three subscales: pre-mentalization, certainty of mental states and interest and curiosity. The PRFQ-A is the version adapted for adolescence of the PRFQ questionnaire. It consists of 18 items and is designed for parents of children aged 12 to 18.
Time frame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Reflective Functioning
The reflective function questionnaire for youth (Fonagy et al., 2016) is a self-report questionnaire composed of 46 items on a 6-point Likert scale that allows to evaluate the reflexive capacity of adolescents aged 12 to 17 years.
Time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
Medical and psychological factors related to pregnancy, post partum and lifestyle
Obstetric, Pathological and Physiological Anamnesis Questionnaire and Lifestyles Questionnaire addressed to the accompanying caregiver to detect obstetric, pathological and physiological anamnesis, data relating to pregnancy, post partum, physiological acts and related pathologies, data relating to the patient's lifestyle (e.g. sleep hygiene) and the use of technological devices.
Time frame: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.
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