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Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C)

Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C)

Non Recruiting
6-12 years
All
Phase N/A

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Overview

Regulation Focused Psychotherapy for Children (RFP-C) is a manualized, time-limited psychodynamic treatment for children with externalizing symptoms. RFP-C also holds the potential to treat a wider range of psychopathology, including comorbid internalizing conditions, because it aims to improve emotion regulation which is a transdiagnostic component of childhood mental health. This study will replicate previous findings supporting the efficacy of RFP-C. It will test the effectiveness of RFP-C in parallel groups via a pragmatic Randomized Controlled Trial (RCT) conducted at Istanbul Bilgi University's outpatient clinic in Istanbul, Turkey with a sample of 80 children with externalizing and comorbid internalizing/externalizing problems in comparison to a parental awareness and child social skills group. The treatment's effectiveness and change mechanisms will be investigated both at short and long term. The project results will provide preliminary answers about the active ingredients of RFP-C, help improve therapeutic interventions, and design optimal treatments for common childhood problems.

Eligibility

Inclusion Criteria:

  1. Children must be between the ages of 6-12 years of age
  2. Meet criteria for clinical levels of externalizing problems on the SDQ
  3. Parent(s) able to attend four sessions of parent meetings

Exclusion Criteria:

  1. Solely emotional problems and non-clinical problem levels (as assessed by the SDQ)
  2. Primary diagnosis of psychosis or eating disorders (as assessed by KSADS-PL)
  3. Risk for suicide and/or severe violence risk (as assessed by KSADS-PL)
  4. Current enrollment in another psychosocial treatment
  5. Intellectual disability or major developmental delay (e.g. moderate/severe autism spectrum disorder) (as assessed by KSADS-PL & WASI)
  6. Families with high risk of domestic abuse
  7. Parents with acute psychosis (as assessed by SCID)
  8. Parents with severe substance abuse and dependence (as assessed by SCID)
  9. Parents with intellectual disability (as assessed by WASI)
  10. Parents with acute risk of harm to self and others (as assessed by SCID)

Study details
    Childhood Externalizing Disorder
    Childhood Oppositional Defiant Disorder
    Childhood Conduct Disorder

NCT06060353

Istanbul Bilgi University

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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