Childhood Externalizing DisorderNCT06060353
Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C)
A study testing Regulation Focused Psychotherapy (RFP-C) and Parental Awareness and Child Social Skills Group in people with Childhood Externalizing Disorder and Childhood Oppositional Defiant Disorder, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Childhood Externalizing Disorder, Childhood Oppositional Defiant Disorder, Childhood Conduct Disorder
- What is being tested?
- Regulation Focused Psychotherapy (RFP-C) and Parental Awareness and Child Social Skills Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2023to 29 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Childhood Externalizing Disorder, Childhood Oppositional Defiant Disorder, Childhood Conduct Disorder
- Being tested
- Regulation Focused Psychotherapy (RFP-C), Parental Awareness and Child Social Skills Group
- Keywords
- Regulation Focused Psychotherapy, Implicit Emotion Regulation, Externalizing Problems
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regulation Focused Psychotherapy (RFP-C)Behavioural
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.
Parental Awareness and Child Social Skills GroupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Regulation Focused Psychotherapy (RFP-C) | Experimental | Not described Receives: Behavioral: Regulation Focused Psychotherapy (RFP-C) |
| Parental Awareness and Child Social Skills Group | Active comparator | Not described Receives: Behavioral: Parental Awareness and Child Social Skills Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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)
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).
Measured: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)
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).
Measured: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
The Emotion Awareness Questionnaire (EAQ-30; Rieffe et al., 2008)
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).
Measured: 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)
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).
Measured: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2)
Parental Stress Index - Short Form (PSI-SF; Abidin, 1983)
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).
Measured: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)
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).
Measured: Time Frame: Baseline (T0), Mid-Treatment (T1), End of Treatment (T2), 36th week (T3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2023
- Study start1 Sep 2023
- Primary completion29 Apr 2025
- Study completion29 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood Externalizing DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Bilgi University
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Regulation Focused Psychotherapy
- Responsible party
- Principal investigator, Sibel Halfon, Istanbul Bilgi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06060353
- Sponsor's protocol ID
- RFP-C
- Status last verified
- Apr 2025
- First submitted
- 23 Sep 2023
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pragmatic Randomized Controlled Trial of Regulation-Focused Psychotherapy (RFP-C) for Children With Externalizing Problems
- ClinicalTrials.gov ID
- NCT06060353
- Acronym / sponsor ID
- RFP-C
- Conditions
- Childhood Externalizing Disorder, Childhood Oppositional Defiant Disorder, Childhood Conduct Disorder
- Keywords
- Regulation Focused Psychotherapy, Implicit Emotion Regulation, Externalizing Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Istanbul Bilgi UniversityUniversity, hospital or other
- Collaborators
- Center for Regulation Focused Psychotherapy
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 29 Apr 2025 (actual)
- Study completion
- 29 Apr 2025 (actual)
- First posted
- 29 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Regulation Focused Psychotherapy (RFP-C) |
| Parental Awareness and Child Social Skills GroupParental 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. | Behavioural | Parental Awareness and Child Social Skills Group |
Primary outcome
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).
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.
6 secondary outcomes
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)
Emotion Regulation Checklist (ERC; Shields & Cicchetti, 1997)
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)
Time frame: 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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- BackgroundHoffman, L., Rice, T., & Prout, T. (2015). Manual of Regulation-Focused Psychotherapy for Children (RFP-C) with externalizing behaviors: A psychodynamic approach. Routledge.
- Individual participant dataSharing planned: No
Related trials for Childhood Externalizing Disorder
RecruitingObservational study
Emotional Dysregulation and Other Psychopathological Dimensions in Clinical Preschoolers
Behavioral and Emotional Disorder With Onset in Childhood
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Regulation Focused Psychotherapy (RFP-C) and Parental Awareness and Child Social Skills Group in people with Childhood Externalizing Disorder and Childhood Oppositional Defiant Disorder, run by Istanbul Bilgi University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06060353, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.