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Somatic Symptom DisorderNCT05666921

Alexithymia and Attachment Style in Patients With Somatic Symptoms

An observational study of Somatic Symptom Disorder, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 11 to 17 years
Conditions the study is for
Somatic Symptom Disorder
What is being tested?
psychological assessment
How many people
300 participants
Where
2 sitesItaly
Study dates
15 Jun 2021to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 11 to 17 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: 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.

Who may be able to join

  • Clinical condition characterized by somatic symptoms such as recurrent abdominal pain, recurrent vomiting, dyspepsia, psychogenic cough, and chronic functional pain (headache, migraine, musculoskeletal pain) for which an organic cause has been excluded and whose symptom has had a strong impact on the quality of life (presence of the symptom for six months, school absenteeism, social isolation, immobility, psychological distress, difficulty in participating in sports and extracurricular activities, etc.), as per Diagnostic and Statistical Manual of Mental Disorders (DSM-5) criteria.
  • Age between 11 and 17 years
  • Italian speaking
  • Patients' and parents' consent

Who cannot join

  • Cognitive and/or developmental impairment
  • Difficulty in understanding the Italian language
  • Presence of organic disease diagnosis
  • Lack of informed consent
  • Patient who does not meet DSM-5 criteria for somatic symptom disorder
  • Caregiver exclusion criteria:
Show all 13Show fewer
  • Cognitive deficits
  • Difficulty in understanding the Italian language
  • Lack of informed consent
  • Control group population inclusion criteria:
  • Age between 11 and 17 years
  • Adequate knowledge of the Italian language
  • Consent to participate

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Rosanna Martin, MSc contact

055 5662475 ext. 0039

rosanna.martin@meyer.it

Giulia Ricci, MSc contact

giulia.ricci@meyer.it

Italy2 sites, 2 recruiting

  • Meyer Children's Hospital

    Florence, Firenze, 50139

    Rosanna Martin, MSc, 055 5662475 ext. 0039, rosanna.martin@meyer.it

    Recruiting

  • IRCCS Gianna Gaslini

    Genova

    Recruiting

Other trials in Italy

About this study

Official title: Somatic Symptoms, Alexithymia and Styles of Attachment: a Cross-sectional Study

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.

Read the detailed description

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.

Being tested
psychological assessment
Keywords
somatic symptoms, alexithymia, attachment style, pain, reflective function
Medical subject headings
Medically Unexplained Symptoms, Affective Symptoms, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • psychological assessmentOther

    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.

Study groups in NCT05666921
Study groupRoleWhat they receive
Pediatric patientsThe 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.
Receives: Other: psychological assessment
Control groupThe 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.
Receives: Other: psychological assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  2. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  3. 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)

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

Secondary outcomes (9)

  1. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  2. 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.

    Measured: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  3. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  4. 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

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  5. Demographic and health variables

    Questionnaire addressed to the accompanying caregiver to collect demographic and disease data together with data on patient life events

    Measured: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  6. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  7. 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.

    Measured: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  8. 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.

    Measured: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

  9. 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.

    Measured: Parents fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Dec 2022
  2. Study start15 Jun 2021
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05666921
Sponsor's protocol ID
somatic symptoms
Status last verified
Sep 2025
First submitted
5 Jan 2022
Last updated
26 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Afari N, Ahumada SM, Wright LJ, Mostoufi S, Golnari G, Reis V, Cuneo JG. Psychological trauma and functional somatic syndromes: a systematic review and meta-analysis. Psychosom Med. 2014 Jan;76(1):2-11. doi: 10.1097/PSY.0000000000000010. Epub 2013 Dec 12.

    PubMed 24336429

  • Andresen JM, Woolfolk RL, Allen LA, Fragoso MA, Youngerman NL, Patrick-Miller TJ, Gara MA. Physical symptoms and psychosocial correlates of somatization in pediatric primary care. Clin Pediatr (Phila). 2011 Oct;50(10):904-9. doi: 10.1177/0009922811406717. Epub 2011 May 16.

    PubMed 21576182

  • Bagby RM, Parker JD, Taylor GJ. The twenty-item Toronto Alexithymia Scale--I. Item selection and cross-validation of the factor structure. J Psychosom Res. 1994 Jan;38(1):23-32. doi: 10.1016/0022-3999(94)90005-1.

    PubMed 8126686

  • Bonvanie IJ, Kallesoe KH, Janssens KAM, Schroder A, Rosmalen JGM, Rask CU. Psychological Interventions for Children with Functional Somatic Symptoms: A Systematic Review and Meta-Analysis. J Pediatr. 2017 Aug;187:272-281.e17. doi: 10.1016/j.jpeds.2017.03.017. Epub 2017 Apr 14.

    PubMed 28416243

  • Cerutti R, Spensieri V, Valastro C, Presaghi F, Canitano R, Guidetti V. A comprehensive approach to understand somatic symptoms and their impact on emotional and psychosocial functioning in children. PLoS One. 2017 Feb 8;12(2):e0171867. doi: 10.1371/journal.pone.0171867. eCollection 2017.

    PubMed 28178333

  • Coddington RD. The significance of life events as etiologic factors in the diseases of children. II. A study of a normal population. J Psychosom Res. 1972 Jun;16(3):205-13. doi: 10.1016/0022-3999(72)90045-1. No abstract available.

    PubMed 5072914

  • Kascakova N, Furstova J, Hasto J, Madarasova Geckova A, Tavel P. The Unholy Trinity: Childhood Trauma, Adulthood Anxiety, and Long-Term Pain. Int J Environ Res Public Health. 2020 Jan 8;17(2):414. doi: 10.3390/ijerph17020414.

    PubMed 31936285

  • Friedrichsdorf SJ, Postier A, Eull D, Weidner C, Foster L, Gilbert M, Campbell F. Pain Outcomes in a US Children's Hospital: A Prospective Cross-Sectional Survey. Hosp Pediatr. 2015 Jan;5(1):18-26. doi: 10.1542/hpeds.2014-0084.

    PubMed 25554755

  • Friedrichsdorf SJ, Giordano J, Desai Dakoji K, Warmuth A, Daughtry C, Schulz CA. Chronic Pain in Children and Adolescents: Diagnosis and Treatment of Primary Pain Disorders in Head, Abdomen, Muscles and Joints. Children (Basel). 2016 Dec 10;3(4):42. doi: 10.3390/children3040042.

    PubMed 27973405

  • Fonagy P, Luyten P, Moulton-Perkins A, Lee YW, Warren F, Howard S, Ghinai R, Fearon P, Lowyck B. Development and Validation of a Self-Report Measure of Mentalizing: The Reflective Functioning Questionnaire. PLoS One. 2016 Jul 8;11(7):e0158678. doi: 10.1371/journal.pone.0158678. eCollection 2016.

    PubMed 27392018

  • Geist R, Weinstein M, Walker L, Campo JV. Medically unexplained symptoms in young people: The doctor's dilemma. Paediatr Child Health. 2008 Jul;13(6):487-91.

    PubMed 19436430

  • Ha C, Sharp C, Ensink K, Fonagy P, Cirino P. The measurement of reflective function in adolescents with and without borderline traits. J Adolesc. 2013 Dec;36(6):1215-23. doi: 10.1016/j.adolescence.2013.09.008. Epub 2013 Oct 25.

    PubMed 24215968

  • Janssens KA, Oldehinkel AJ, Rosmalen JG. Parental overprotection predicts the development of functional somatic symptoms in young adolescents. J Pediatr. 2009 Jun;154(6):918-23.e1. doi: 10.1016/j.jpeds.2008.12.023. Epub 2009 Feb 1.

    PubMed 19181331

  • Janssens KA, Rosmalen JG, Ormel J, van Oort FV, Oldehinkel AJ. Anxiety and depression are risk factors rather than consequences of functional somatic symptoms in a general population of adolescents: the TRAILS study. J Child Psychol Psychiatry. 2010 Mar;51(3):304-12. doi: 10.1111/j.1469-7610.2009.02174.x. Epub 2009 Sep 28.

    PubMed 19788552

  • King S, Chambers CT, Huguet A, MacNevin RC, McGrath PJ, Parker L, MacDonald AJ. The epidemiology of chronic pain in children and adolescents revisited: a systematic review. Pain. 2011 Dec;152(12):2729-2738. doi: 10.1016/j.pain.2011.07.016.

    PubMed 22078064

Questions about this trial

What is this clinical trial studying?

An observational study of Somatic Symptom Disorder, run by Meyer Children's Hospital IRCCS at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 26 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Rosanna Martin, MSc (055 5662475 ext. 0039, rosanna.martin@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Emotional awareness (time frame: Patients fill out the questionnaire at their enrollment in the study, during their first psychological consult after medical referral.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05666921, which also lists 25 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2025.

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