NCT05666921

Brief 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 to an insecure attachment style.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Jun 2021

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2021Dec 2026

Study Start

First participant enrolled

June 15, 2021

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

December 28, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

September 26, 2025

Status Verified

September 1, 2025

Enrollment Period

5.5 years

First QC Date

January 5, 2022

Last Update Submit

September 24, 2025

Conditions

Keywords

somatic symptomsalexithymiaattachment stylepainreflective function

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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)

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

Secondary Outcomes (9)

  • Stressful life events

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

  • Behavioral and emotional issues

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

  • stress and protection indicators

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

  • pain coping strategies

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

  • Demographic and health variables

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

  • +4 more secondary outcomes

Study Arms (2)

Pediatric patients

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

Control group

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

Interventions

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.

Control groupPediatric patients

Eligibility Criteria

Age11 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Cognitive deficits
  • Difficulty in understanding the Italian language
  • Lack of informed consent
  • Age between 11 and 17 years
  • Adequate knowledge of the Italian language
  • Consent to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Meyer Children's Hospital

Florence, Firenze, 50139, Italy

RECRUITING

IRCCS Gianna Gaslini

Genova, Italy

RECRUITING

Related Publications (25)

  • 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.

    PMID: 24336429BACKGROUND
  • 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.

    PMID: 21576182BACKGROUND
  • 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.

    PMID: 8126686BACKGROUND
  • 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.

    PMID: 28416243BACKGROUND
  • 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.

    PMID: 28178333BACKGROUND
  • 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.

    PMID: 5072914BACKGROUND
  • 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.

    PMID: 31936285BACKGROUND
  • 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.

    PMID: 25554755BACKGROUND
  • 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.

    PMID: 27973405BACKGROUND
  • 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.

    PMID: 27392018BACKGROUND
  • 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.

    PMID: 19436430BACKGROUND
  • 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.

    PMID: 24215968BACKGROUND
  • 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.

    PMID: 19181331BACKGROUND
  • 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.

    PMID: 19788552BACKGROUND
  • 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.

    PMID: 22078064BACKGROUND
  • Kugler BB, Bloom M, Kaercher LB, Truax TV, Storch EA. Somatic symptoms in traumatized children and adolescents. Child Psychiatry Hum Dev. 2012 Oct;43(5):661-73. doi: 10.1007/s10578-012-0289-y.

    PMID: 22395849BACKGROUND
  • Luyten P, Mayes LC, Nijssens L, Fonagy P. The parental reflective functioning questionnaire: Development and preliminary validation. PLoS One. 2017 May 4;12(5):e0176218. doi: 10.1371/journal.pone.0176218. eCollection 2017.

    PMID: 28472162BACKGROUND
  • Moreno MA. Functional abdominal pain in children and adolescents. JAMA Pediatr. 2013 Feb;167(2):204. doi: 10.1001/jamapediatrics.2013.1665. No abstract available.

    PMID: 23381459BACKGROUND
  • Schulte IE, Petermann F. Somatoform disorders: 30 years of debate about criteria! What about children and adolescents? J Psychosom Res. 2011 Mar;70(3):218-28. doi: 10.1016/j.jpsychores.2010.08.005. Epub 2010 Nov 4.

    PMID: 21334492BACKGROUND
  • Taylor EM, Boyer K, Campbell FA. Pain in hospitalized children: a prospective cross-sectional survey of pain prevalence, intensity, assessment and management in a Canadian pediatric teaching hospital. Pain Res Manag. 2008 Jan-Feb;13(1):25-32. doi: 10.1155/2008/478102.

    PMID: 18301813BACKGROUND
  • Taylor GJ, Parker JD, Bagby RM, Acklin MW. Alexithymia and somatic complaints in psychiatric out-patients. J Psychosom Res. 1992 Jul;36(5):417-24. doi: 10.1016/0022-3999(92)90002-j.

    PMID: 1619582BACKGROUND
  • Troisi A, D'Argenio A, Peracchio F, Petti P. Insecure attachment and alexithymia in young men with mood symptoms. J Nerv Ment Dis. 2001 May;189(5):311-6. doi: 10.1097/00005053-200105000-00007.

    PMID: 11379975BACKGROUND
  • van der Veek SM, Derkx HH, de Haan E, Benninga MA, Boer F. Emotion awareness and coping in children with functional abdominal pain: a controlled study. Soc Sci Med. 2012 Jan;74(2):112-9. doi: 10.1016/j.socscimed.2011.10.023. Epub 2011 Nov 27.

    PMID: 22196250BACKGROUND
  • Varni JW, Waldron SA, Gragg RA, Rapoff MA, Bernstein BH, Lindsley CB, Newcomb MD. Development of the Waldron/Varni pediatric pain coping inventory. Pain. 1996 Sep;67(1):141-150. doi: 10.1016/0304-3959(96)03077-1.

    PMID: 8895242BACKGROUND
  • Wearden AJ, Lamberton N, Crook N, Walsh V. Adult attachment, alexithymia, and symptom reporting: an extension to the four category model of attachment. J Psychosom Res. 2005 Mar;58(3):279-88. doi: 10.1016/j.jpsychores.2004.09.010.

    PMID: 15865953BACKGROUND

MeSH Terms

Conditions

Medically Unexplained SymptomsAffective SymptomsPain

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavioral SymptomsBehaviorNeurologic Manifestations

Study Officials

  • Rosanna Martin, MSc

    Meyer Children's Hospital IRCCS

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosanna Martin, MSc

CONTACT

Giulia Ricci, MSc

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 5, 2022

First Posted

December 28, 2022

Study Start

June 15, 2021

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

September 26, 2025

Record last verified: 2025-09

Locations