Assessing Real Life Effectiveness of Treatment in Neurodevelopmental Disorders

NCT07273695 | Recruiting

• 2 other identifiers: 1120Ricerca Corrente
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to learn if and how pharmacological and psychotherapeutic group treatments can treat clinical symptoms of children and adolescent patients with ADHD. The main questions it aims to answer are:

• Are pharmacological and psychotherapeutic treatments effective on the clinical symptoms of patients with ADHD?
• Are pharmacological and psychotherapeutic treatments effective on symptoms of emotion-behavioral dysregulation?
• Is it possible to find associations between individual characteristics and treatment responses evaluating behavioral and neural correlates in children and adolescents with traits of emotion-behavioral dysregulation, externalizing disorders, and/or ADHD, using a panel of multimodal measures. May the data collected contribute to the definition of profiles useful for generating predictive hypotheses aimed at developing more personalized interventions? Researchers will compare the data collected from patients treated with pharmacological and psychotherapeutic group treatments with the data of subjects of comparable sex/gender, age, diagnoses, on the waiting list for treatment to see if pharmacological and psychotherapeutic treatments effects ADHD and emotional dysregulation symprtoms. Participants, patients who are offered treatment by clinicians according to standard clinical practice, will be asked to participate in the study by undergoing experimental assessments before and after the treatment. The multimodal panel of proposed assessments includes:
• behavioral assessments, conducted through the completion of clinical and socio-demographic questionnaires;
• neuropsychological assessments, conducted through standardized computerized neuropsychological tests;
• neurophysiological assessments, conducted through the recording of NIRS (near infrared spectroscopy) and EEG (electroencephalogram) signals during an attentional task (Go-NoGo) and via a smartwatch.

Conditions

Externalizing Problems; Oppositional Defiant; Conduct Disorder; Attention Deficit Hyerpactivity Disorder; Emotional Dysregulation; Disruptive Behaviours

Keywords

attention deficit hyperactivity disorder; child training; methylphenidate; emotional dysregulation; externalizing disorders/behaviors

Outcome Measures

Primary Outcomes (1)

• Clinical Global Impressions - Severity Scale

  Clinical improvement measured with CGI-s (Clinical Global Impression - severity)(minimum value: 1 = "normal, not ill"; maximun value: 7 = "very severely ill" )

  T2 (2-3 months), T3 (6 months)

Secondary Outcomes (1)

• Difficulties in Emotion Regulation Scale - DERS

  T2 (2-3 months), T3 (6 months)

Other Outcomes (1)

• explanatory outcomes

  T2 (2-3 months), T3 (6 months)

Study Arms (3)

participants beguinning drug treatment

children and adolescents with emotional dysregulation, externalizing disorders and/or ADHD beguinning drug treatment (MPH)

Drug: methyphenidate

participants beguinning group psychotherapy

children and adolescents with emotional dysregulation externalizing disorders and/or ADHD beguinning group psychotherapy (child training)

Behavioral: Group psychological treatment

control groups

children and adolescents with emotional dysregulation, externalizing disorders and/or ADHD in waiting list to beguin their treatment

Interventions

Group psychological treatment BEHAVIORAL

The treatment consists of 16 weekly sessions lasting 1.5 hours. The total duration of the intervention is 4 months for a total of 16 sessions. The therapeutic group will be a closed group with approximately 6 patients per group. Patients will be assigned to different groups based on age and skills (8-11 and 12-15 years). The proposed interventions are based on the theoretical principles and techniques of Schema Therapy for developmental age (Christof Loose, Peter Graaf, Gerhard Zarbock \& Ruth A. Holt; Italian edition edited by Stefano Terenzi and Rosario Capo, 2013) or Acceptance and Commitment Therapy (Vanzin et al., 2020a; 2020b) for externalizing disorders.

participants beguinning group psychotherapy

methyphenidate DRUG

According to clinical practice and national guidelines, subjects who meet the severity criteria and who express their consent to undertake pharmacological therapy undergo the medical tests required for the initiation of therapy. Only subsequently, according to standard clinical practice, the patient is subjected to the test dose of methylphenidate in the facility, in order to monitor any side effects. The dosage prescribed to patients varies depending on the subject's characteristics (5-20 mg/day) and is set by the child neuropsychiatrist based on the response to treatment, tolerability, and adverse effects, , according to Italian clinical guidelines for children and adolescents (SINPIA, 2002).

Also known as: Drug treatment

participants beguinning drug treatment

Eligibility Criteria

• Age: 8 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with symptoms of emotional-behavioral dysregulation, externalizing disorders, and/or ADHD will be recruited. The presence of these symptoms and diagnoses must be assessed prior to entry into the research project by experienced clinicians through clinical interviews and questionnaires. Children and adolescents aged 8-15 will be recruited. For psychotherapeutic treatment, participants will be divided into separate groups based on age and skills: 8-11 and 12-15. Patients with an IQ greater than 75 will be recruited, and, for the psychotherapeutic treatment group, those with good mentalization skills. Pharmacological intervention will be proposed in indicated cases following international guidelines (for example, for ADHD, treatment with methylphenidate is administered in cases of Clinical Global Index severity (CGI-S) ≥ 4). A control group will be recruited consisting of patients on the waiting list for treatment, with the same diagnoses and comparable age.

You may qualify if:

• Children and adolescents aged 8-15 years;
• Diagnosis of externalizing disorder, ADHD, and/or emotional dysregulation (assessed with questionnaires, interviews, and/or clinical observation);
• Intelligence quotient ≥ 75.

You may not qualify if:

• IQ \< 75;
• Substance abuse and addictions;
• Psychosis;
• Acute disorders;
• Organic brain disorders;
• Presence of neurological diseases, epilepsy;
• Genetic syndromes;

Sponsors & Collaborators

• IRCCS Eugenio Medea: lead

Study Sites (1)

IRCCS E Medea Scientific Institute - Asssociazione La Nostra Famiglia

Bosisio Parini, Lecco, Italy

RECRUITING

Related Publications (9)

• Mauri M, Grazioli S, Crippa A, Bacchetta A, Pozzoli U, Bertella S, Gatti E, Maggioni E, Rosi E, Diwadkar V, Brambilla P, Molteni M, Nobile M. Hemodynamic and behavioral peculiarities in response to emotional stimuli in children with attention deficit hyperactivity disorder: An fNIRS study. J Affect Disord. 2020 Dec 1;277:671-680. doi: 10.1016/j.jad.2020.08.064. Epub 2020 Sep 1.

  PMID: 32911217 BACKGROUND

• Achenbach, T. (2001). Manual for the ASEBA school-age forms and profiles

  BACKGROUND

• Vanzin, L., Mauri, V., Valli, A., Pozzi, M., Presti, G., Oppo, A., ... & Nobile, M. (2020a). Clinical effects of an ACT-group training in children and adolescents with attention-deficit/hyperactivity disorder. Journal of Child and Family Studies, 29, 1070-1080.

  BACKGROUND

• Vanzin, L., Crippa, A., Mauri, V., Valli, A., Mauri, M., Molteni, M., & Nobile, M. (2020b). Does ACT-group training improve cognitive domain in children with attention deficit hyperactivity disorder? A single-arm, open-label study. Behaviour Change, 37(1), 33-44. doi:https://doi.org/10.1017/bec.2020.3

  BACKGROUND

• Conners C. K. (2008), Conners 3rd Edition (Conners 3). Ad. it. di C. Primi e D. Maschietto, Giunti Psychometrics, Firenze 2017.

  BACKGROUND

• Mauri M, Crippa A, Bacchetta A, Grazioli S, Rosi E, Gazzola E, Gallace A, Nobile M. The utility of NIRS technology for exploring emotional processing in children. J Affect Disord. 2020 Sep 1;274:819-824. doi: 10.1016/j.jad.2020.06.004. Epub 2020 Jun 3.

  PMID: 32664020 BACKGROUND

• Grazioli S, Mauri M, Crippa A, Maggioni E, Molteni M, Brambilla P, Nobile M. Light up ADHD: II. Neuropharmacological effects measured by near infrared spectroscopy: is there a biomarker? J Affect Disord. 2019 Feb 1;244:100-106. doi: 10.1016/j.jad.2018.10.100. Epub 2018 Oct 9.

  PMID: 30332620 BACKGROUND

• Grazioli S, Rosi E, Mauri M, Crippa A, Tizzoni F, Tarabelloni A, Villa FM, Chiapasco F, Reimers M, Gatti E, Bertella S, Molteni M, Nobile M. Patterns of Response to Methylphenidate Administration in Children with ADHD: A Personalized Medicine Approach through Clustering Analysis. Children (Basel). 2021 Nov 4;8(11):1008. doi: 10.3390/children8111008.

  PMID: 34828721 BACKGROUND

• Mauri M, Nobile M, Bellina M, Crippa A, Brambilla P. Light up ADHD: I. Cortical hemodynamic responses measured by functional Near Infrared Spectroscopy (fNIRS): Special Section on "Translational and Neuroscience Studies in Affective Disorders" Section Editor, Maria Nobile MD, PhD. This Section of JAD focuses on the relevance of translational and neuroscience studies in providing a better understanding of the neural basis of affective disorders. The main aim is to briefly summarise relevant research findings in clinical neuroscience with particular regards to specific innovative topics in mood and anxiety disorders. J Affect Disord. 2018 Jul;234:358-364. doi: 10.1016/j.jad.2017.11.087. Epub 2017 Nov 21.

  PMID: 29195758 BACKGROUND

MeSH Terms

Conditions

Conduct Disorder; Attention Deficit Disorder with Hyperactivity; Behavior

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Maria Nobile, PhD, MD

  IRCCS E Medea Scientific Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Nobile, PhD, MD

CONTACT

+39031877563; maria.nobile@lanostrafamiglia.it

Maddalena Mauri, PhD

CONTACT

340031877813; maddalena.mauri@lanostrafamiglia.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 9 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: December 9, 2025
• Study Start: September 19, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Locations

IT (1)