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

NCT06060353 | Completed

• 1 other identifier: RFP-C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Childhood Externalizing Disorder; Childhood Oppositional Defiant Disorder; Childhood Conduct Disorder

Keywords

Regulation Focused Psychotherapy; Implicit Emotion Regulation; Externalizing Problems

Outcome Measures

Primary Outcomes (2)

• Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001)

  Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001) is a 25-item scale that asks parents to rate their children's emotional and behavioral difficulties on a 3-point Likert scale, ranging from 0 = not true to 2 = very true. The questionnaire is composed of five subscales: Emotional Symptoms, Conduct Problems, Hyperactivity-Inattention, Peer Problems and Prosocial. In addition, the SDQ-P yields Internalizing Difficulties, Externalizing Difficulties and Total Difficulties scale scores. SDQ-P was demonstrated to be a valid and reliable scale for use in Turkish children and adolescents (Yalın et al., 2013).

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

• Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994)

  Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994) is based on DSM-IV diagnostic criteria and examines hyperactivity/impulsivity, inattention, opposition-defiance, and conduct disorder. Symptoms are scored on a four-point Likert scale (0= not at all, 1= just a little, 2= quite a bit, and 3= very much). T-DSM-IV-S has shown good reliability and validity.

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

Secondary Outcomes (6)

• Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

• Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

• The Emotion Awareness Questionnaire (EAQ-30; Rieffe et al., 2008)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

• The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)

• Parental Stress Index - Short Form (PSI-SF; Abidin, 1983)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

Other Outcomes (3)

• Adverse Childhood Experiences Scale (ACE; Dube et al., 2004)

  Time Frame: Baseline (T0)

• The Therapeutic Alliance Scale for Children-revised (TASC-r; Creed &Kendall, 2005)

  Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)

• Wechsler Abbreviated Scale of Intelligence (WASI-II; Weschler, 1999)

  Time Frame: Baseline (T0)

Study Arms (2)

Regulation Focused Psychotherapy (RFP-C)

EXPERIMENTAL

Behavioral: Regulation Focused Psychotherapy (RFP-C)

Parental Awareness and Child Social Skills Group

ACTIVE COMPARATOR

Behavioral: Parental Awareness and Child Social Skills Group

Interventions

Regulation Focused Psychotherapy (RFP-C) BEHAVIORAL

Regulation-focused psychotherapy for children (RFP-C; Hoffman, Rice, \& Prout, 2016) is a manualized, psychodynamic play therapy. Through 20 sessions (16 with the child and four parent meetings), RFP-C allows the child to understand the ways distressing affects are avoided and to explore alternative ways of coping with unpleasant affect. The clinician works to increase the child's understanding that all behavior, especially oppositional and disruptive behavior, has meaning in the service of emotional and behavioral regulation. This work is also done with the parents to better support the child in achieving symptom reduction and increased emotion regulation.

Regulation Focused Psychotherapy (RFP-C)

Parental Awareness and Child Social Skills Group BEHAVIORAL

Parental awareness and child social skills group is a manualized group psychotherapy that involves twelve parallel sessions conducted separately with parents and children. The parent group involves modules related to psycho-education, role-play and awareness building activities on child needs \& rights, child temperament, praise \& acceptance, child play, limit setting, anger management, transmission of parenting styles through genograms and family trees. With children, the groups involve psycho-education and play based activities to build awareness on children's rights, temperament, feelings, play \& relationship skills, empathy \& praise, anger management.

Parental Awareness and Child Social Skills Group

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Istanbul Bilgi University: lead
• Center for Regulation Focused Psychotherapy: collaborator

Study Sites (1)

Istanbul Bilgi University

Istanbul, 34060, Turkey (Türkiye)

Location

Related Publications (1)

• Hoffman, L., Rice, T., & Prout, T. (2015). Manual of Regulation-Focused Psychotherapy for Children (RFP-C) with externalizing behaviors: A psychodynamic approach. Routledge.

  BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 23, 2023
• First Posted: September 29, 2023
• Study Start: September 1, 2023
• Primary Completion: April 29, 2025
• Study Completion: April 29, 2025
• Last Updated: June 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)