Status:

COMPLETED

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

Lead Sponsor:

Istanbul Bilgi University

Collaborating Sponsors:

Center for Regulation Focused Psychotherapy

Conditions:

Childhood Externalizing Disorder

Childhood Oppositional Defiant Disorder

Eligibility:

All Genders

6-12 years

Phase:

NA

Brief Summary

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 ra...

Eligibility Criteria

Inclusion

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

Exclusion

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

Key Trial Info

Start Date :

September 1 2023

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 29 2025

Estimated Enrollment :

80 Patients enrolled

Trial Details

Trial ID

NCT06060353

Start Date

September 1 2023

End Date

April 29 2025

Last Update

June 10 2025

Active Locations (1)

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1

Istanbul Bilgi University

Istanbul, Turkey (Türkiye), 34060