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

Last updated: April 28, 2025
Sponsor: Istanbul Bilgi University
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Kleptomania

Oppositional Defiant Disorder (Odd)

Treatment

Regulation Focused Psychotherapy (RFP-C)

Parental Awareness and Child Social Skills Group

Clinical Study ID

NCT06060353
RFP-C
  • Ages 6-12
  • All Genders

Study 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 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. Primary outcomes will be child externalizing problems and oppositional defiance problems. The treatment's effectiveness and change mechanisms will be investigated both at the end of treatment (primary endpoint) and at 6-month follow-up (secondary endpoint). The project results will provide preliminary answers about the active ingredients of RFP-C, help improve therapeutic interventions, and design optimal treatments for externalizing problems.

Eligibility Criteria

Inclusion

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

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 autismspectrum 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 Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Regulation Focused Psychotherapy (RFP-C)
Phase:
Study Start date:
September 01, 2023
Estimated Completion Date:
June 01, 2025

Connect with a study center

  • Istanbul Bilgi University

    Istanbul, 34060
    Turkey

    Site Not Available

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