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

June 5, 2025 updated by: Sibel Halfon, Istanbul Bilgi University

A Pragmatic Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C) for Children With Externalizing Problems

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34060
        • Istanbul Bilgi University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Regulation Focused Psychotherapy (RFP-C)
Behavioral: Regulation Focused Psychotherapy (RFP-C)
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.
Active Comparator: Parental Awareness and Child Social Skills Group
Behavioral: Parental Awareness and Child Social Skills Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Strengths and Difficulties Questionnaire - Parent version (SDQ-P; Goodman, 2001)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
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)
Time Frame: 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) 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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Me and My Feelings Questionnaire (M&MF; Deighton et al., 2013) is a child-report measure consisting of total short 16-items: 10-items of emotional difficulties scale and 6-items of behavioral difficulties scale. It is scored on a 3-point likert scale (0 = "never expressed", 1 = "sometimes expressed", 2 = "always expressed"). Total score of scales are calculated as the sum of item scores with threshold values 10 for the emotional difficulties and six for the behavioral difficulties. Higher scores of each set of difficulties indicate the probability of mental health problems. The scale has been adapted to Turkish with good reliability and validity (İlnem, 2020).
Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997) is a parent-report measure of children's emotion regulation characteristics and involves 24-items rated on a 5-point likert scale (1 = "never" to 5 = "always"). It taps into two factors one of which is emotional lability and negativity defined as arousal, anger dysregulation, and mood changes; and the second is emotion regulation defined as socially appropriate emotional displays, empathy, and emotional selfawareness. The scale has been adapted to Turkish with good reliability and validity (Batum & Yagmurlu, 2007).
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: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
The Emotion Awareness Questionnaire (EAQ-30; Rieffe et al., 2008) aims to identify how children and adolescents feel and think about their feelings. The EAQ (30 items) was designed with a six-factor structure describing six aspects of emotional functioning: (1) Differentiating Emotions, (2) Verbal Sharing of Emotions, (3) Not Hiding Emotions (formerly Acting Out), (4) Bodily Awareness of Emotions, (5) Attending to Others' Emotions, and (6) Analyses of Emotions. Respondents are asked to rate the degree to which each item is true about them on a three-point scale (1 = not true, 2 = sometimes true, 3 = often true). The scale has been adapted to Turkish with good reliability and validity (İnceman, 2017).
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: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
The Children's Global Assessment Scale (CGAS; Schaffer et al., 1983) is a numeric scale (from 1 to 100) used by mental health clinicians to rate the global functioning of children under the age of 18 on a scale of 0 to 100. 90- 81 range is scored when there is "good functioning in all areas; security in family, school, and with peers with only transient difficulties and everyday worries"; 50-41, when there is "moderate degree of interference in functioning in most social areas or severe impairment of functioning in one area"; and 20-11, when there is "need for considerable supervision to prevent hurting others or self or to maintain personal hygiene or gross impairment in all forms of communication". The scale has been adapted to Turkish with good reliability and validity (Gökler et al., 2004).
Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
Parental Stress Index - Short Form (PSI-SF; Abidin, 1983)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Parental Stress Index - Short Form (PSI-SF; Abidin, 1983) is a 36-item parent-report scale.The PSI-SF contains 36 items divided into three subscales, each composed of 12 items: "Parental distress"; "Parent-child dysfunctional interaction"; "Difficult child". Each item is rated on a 5-point likert scale from 1 = "strongly disagree" to 5 = strongly agree". The PSI-SF gives three subscores and a total distress score. The scale has been adapted to Turkish with good reliability and validity (Ertan et al., 2008).
Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004) is an instrument measuring emotion regulation problems in adults (to be used with parents in the current study). The scale comprises 36 items that are rated on a 5- point likert scale from 1 = "almost never" to 5 = "almost always", with higher scores indicating a difficulty of emotion regulation. The scale produces scores on the following subscales: (a) lack of awareness of emotional responses; (b) lack of clarity of emotional responses; (c) nonacceptance of emotional responses; (d) limited access to effective strategies; (e) difficulties in controlling impulsive behavior when experiencing negative affect; and (f) difficulties in engaging goal directed behavior when experiencing negative affect as well as a total disregulation score. The scale has been adapted to Turkish with good reliability and validity (Yiğit & Güzey-Yiğit, 2017).
Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Therapeutic Alliance Scale for Children-revised (TASC-r; Creed &Kendall, 2005)
Time Frame: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
The Therapeutic Alliance Scale for Children-revised (TASC-r; Creed &Kendall, 2005) is a 12-item tool that measures alliance across the three dimensions of task, bond and goals and covers both positive and negative aspects of therapeutic alliance. Each response is rated on a four point Likert scale (i.e. ''not at all like my client'' to ''very much like my client''). It has been found to have adequate reliability and validity in Turkey (Bulut, et al., 2023).
Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
Adverse Childhood Experiences Scale (ACE; Dube et al., 2004)
Time Frame: Time Frame: Baseline (T0)
Adverse Childhood Experiences Scale (ACE; Dube et al., 2004) is a parent-report scale to assess retrospectively forms of abuse, neglect, and household dysfunction (i.e., witnessing domestic violence, separation and mental illness in the family) in the current study. Scores range from 0-10 on the ACE, with the latter representing full exposure at some point in the first 18 years of life, to all forms of household dysfunction and abuse detailed in the questionnaire.It has a parent and a child version. The scale has been adapted to Turkish by Gunduz et al. (2018).
Time Frame: Baseline (T0)
Wechsler Abbreviated Scale of Intelligence (WASI-II; Weschler, 1999)
Time Frame: Time Frame: Baseline (T0)
Wechsler Abbreviated Scale of Intelligence (WASI-II; Weschler, 1999) is a brief measure of verbal and nonverbal intelligence administered by trained researchers to parents and children.
Time Frame: Baseline (T0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Bilgi University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Center for Regulation Focused Psychotherapy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 29, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 29, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 23, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 23, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 10, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RFP-C

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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