Clinical trial NCT06060353: Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C)
Official title: A Pragmatic Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C) for Children With Externalizing Problems
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Externalizing Disorder
Childhood Oppositional Defiant Disorder
Childhood Conduct Disorder
Keywords: Regulation Focused Psychotherapy
Implicit Emotion Regulation
Externalizing Problems
Lead sponsor: Istanbul Bilgi University
Sponsor class: OTHER
Collaborators: name: Center for Regulation Focused Psychotherapy
First posted: 2023-09-29
Enrollment: 80
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
measure: Turgay DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) Disruptive Behavior Disorders Rating Scale (T-DSM-IV-S; Turgay, 1994)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Secondary outcomes:
measure: Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
measure: Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
measure: The Emotion Awareness Questionnaire (EAQ-30; Rieffe et al., 2008)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
measure: The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
measure: Parental Stress Index - Short Form (PSI-SF; Abidin, 1983)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
measure: Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Other outcomes:
measure: Adverse Childhood Experiences Scale (ACE; Dube et al., 2004)
timeFrame: Time Frame: Baseline (T0)
measure: The Therapeutic Alliance Scale for Children-revised (TASC-r; Creed &Kendall, 2005)
timeFrame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
measure: Wechsler Abbreviated Scale of Intelligence (WASI-II; Weschler, 1999)
timeFrame: Time Frame: Baseline (T0)
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Bilgi University
Study officials:
References:
citation: Hoffman, L., Rice, T., & Prout, T. (2015). Manual of Regulation-Focused Psychotherapy for Children (RFP-C) with externalizing behaviors: A psychodynamic approach. Routledge.