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CompletedNCT03594253RFP-CUpdated Jan 30, 2023

Evaluation of Regulation Focused Psychotherapy for Children

An interventional study of Regulation Focused Psychotherapy for Children in Oppositional Defiant Disorder and Oppositional Defiant Disorder in Children, sponsored by Yeshiva University. Completed at 1 site in United States. Open to participants aged 5 Years to 12 Years. Per ClinicalTrials.gov, last updated 2023-01-30.

Sponsored by Yeshiva University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 1 month after the study started (first participant enrolled Jan 2017, registered Feb 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
5 Years to 12 Years
Sex
All
01

Study summary

The main objective of this project is to conduct a study of RFP-C for children with disruptive behaviors. Regulation Focused Psychotherapy for Children (RFP-C) is a twice a week, play therapy intervention.

Read the detailed description

Background/Significance Currently, there are no empirically supported, manualized psychodynamic treatments for children and adolescents with disruptive behavior problems. Many barriers exist to providing effective treatment, including the large dropout rates in child psychotherapy, especially when multiple risk factors are present, such as maternal stress, greater symptom severity, and lower socioeconomic status. In order to remain viable and competitive, clinicians and researchers must demonstrate that psychodynamic approaches are valuable in terms of positive clinical outcomes, cost-effectiveness, and ease of implementation across a range of settings and disciplines.

Externalizing behaviors are common in a wide range of child mental health problems, including oppositional defiant disorder, disruptive mood dysregulation disorder, and conduct disorder. These behaviors have high prevalence rates, ranging from 15 to 34 percent. These problems frequently result in the referral of young children to mental health providers and they are costly to the healthcare system overall . The current approach to these types of problems is to provide behavioral parent management training (PMT) to parents of the child in distress. These programs include Parent-Child Interaction Therapy, Triple P-Positive Parenting Program, or The Incredible Years. Behavioral parent training programs are widely used because the evidence shows they are efficacious for children with externalizing behaviors. PMT relies on traditional cognitive behavioral strategies in working with the parent, including behavioral modeling, rewards, reinforcement, and punishment. The parent is taught to set limits for the child and to direct and to shape behavior. A significant limitation associated with behavioral parent programs (and psychotherapy with children and adolescents in general) is elevated attrition rates for vulnerable populations due to factors such as low socioeconomic status, ethnic minority status, parental functioning, maternal stress, low parental motivation, and child symptom severity. Parental attrition in behavioral parent training is also due to parental attribution about where the problem resides - within the child. PMT is directed at the parent, which contradicts the parent's understanding of the cause and nature of the problem, thus sometimes further reducing motivation to seek and complete treatment.

Regulation Focused Psychotherapy for Children (RFP-C) is a novel, manualized, time-limited psychodynamic treatment approach for children who manifest disruptive behaviors and emotional dysregulation. RFP-C conceptualizes children's externalizing behaviors as expressions of maladaptive defenses or impaired emotion regulation (ER). The child's behaviors are understood as products of developmental delays in implicit ER. This system has defined neurofunctional correlates which permit a targeting of the therapeutic work to brain-based deficits in the child's normative development. Externalizing behaviors are thus conceptualized both as biologically-driven products and as functional attempts to defend against painful emotions by protecting the child from disturbing feelings such as sadness, shame, and guilt. RFP-C relies heavily on the child being able to experience distressing affects through play and through the relationship with the therapist. Throughout the 16 sessions of play therapy and several parent meetings, the clinician works with the parents and the child to increase understanding that all behavior, even disruptive behavior, has meaning in the service of emotional and behavioral regulation. This insight leads to a decreased need and reliance to act on the distressing emotions (e.g. less need for disruptive behaviors) and an increased ability to tolerate, work through, and talk about the feelings that previously needed to be warded off.

This 16-session (plus four parent sessions) psychotherapy method operationalizes individual play therapy approaches for children with externalizing behaviors, including oppositional defiant disorder (ODD). Play therapy has long been the mainstay of community mental health with children and adolescents and has demonstrated efficacy, though no one has developed a play-based manualized treatment for children to date. Through iteratively addressing a child's disruptive behaviors as strategies to avoid painful affect, RFP-C is hypothesized to address developmental immaturity of the implicit ER system.

Rationale There is a critical need for the development, evaluation, and implementation of evidence-based psychodynamic treatments for children and adolescents. Regulation Focused Psychotherapy for Children is a novel, manualized, time-limited psychodynamic treatment approach for children who manifest disruptive behaviors and emotional dysregulation. To date, we have only conducted a small pilot study of the RFP-C method. No clinical trial has been conducted to determine the outcomes associated with RFP-C in a larger sample. The immediate objective of this proposal is to conduct a randomized controlled trial with 20 children in order to evaluate comparable efficacy to a waitlist control group.

02

Conditions studied

  • Oppositional Defiant Disorder
  • Oppositional Defiant Disorder in Children

Keywords

  • oppositional defiant disorder
  • regulation focused psychotherapy for children
  • emotion regulation
  • psychodynamic psychotherapy
03

In context

Oppositional Defiant Disorder

86 studies on the registry are indexed under Oppositional Defiant Disorder; 16 are open to participants now.

This study's enrollment of 40 is below the median of 102 across 76 interventional studies indexed under Oppositional Defiant Disorder.

Browse Oppositional Defiant Disorder studies →

Lead sponsor

Yeshiva University is the lead sponsor of 8 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
5 Years to 12 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Experiencing symptoms of ODD
  • Fluent in English
  • Not diagnosed with severe autism spectrum disorder
  • Able to attend therapy twice a week for 10 weeks in the Bronx
  • No concurrent therapy services (psychosocial groups and Individualized Education Plan supports are acceptable)

Exclusion criteria

Exclusion Criteria:

  • Active Administration for Children's Services (ACS)/Child Protective Services (CPS) involvement
  • Severe autism spectrum disorder
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    RFP-C

    Regulation Focused Psychotherapy for Children (RFP-C; Hoffman \& Rice with Prout, 2015) is a novel, manualized, time-limited psychodynamic treatment approach for children who manifest disruptive behaviors and emotional dysregulation. Throughout the 16 sessions of play therapy and four parent meetings, the clinician works with the parents and the child to increase understanding that all behavior, even disruptive behavior, has meaning in the service of emotional and behavioral regulation. This insight leads to a decreased need and reliance to act on the distressing emotions (e.g. less need for disruptive behaviors) and an increased ability to tolerate, work through, and talk about the feelings that previously needed to be warded off.

    Behavioral: Regulation Focused Psychotherapy for Children

  • No intervention
    Wait List control

    Participants assigned to this condition will receive no intervention. They may continue on current medication regimens (no major changes) but may not be enrolled in psychological treatments. They will be evaluated weekly via phone call with primary caregiver. At the conclusion of this 10-week wait list period all participants assigned to this condition will receive RFP-C treatment.

Interventions

  • BehavioralRegulation Focused Psychotherapy for Children

    RFP-C is a manualized, psychodynamic psychotherapy that last 10 weeks. Children meet individually with a therapist for play therapy (twice a week for 16 sessions) and parents meet with the therapist for four full sessions (without the child).

    Also known as: RFP-C

06

What researchers measure

Primary outcomes

  1. Oppositional Defiant Disorder Rating Scale

    symptom inventory based on Diagnostic and Statistical Manual (DSM) 5 - parent report Total possible score ranges from 0 - 24 with 0 representing no oppositional defiant disorder symptoms and 24 representing the most intense and frequent degree of oppositional defiant symptoms

    Time frame: Pre and post treatment (prior to randomization, after 10 week wait list period if appropriate, and again after completion of 10 week treatment)

Secondary outcomes

  1. Emotion Regulation Checklist

    Parent report of ER capacities The ERC assessed children's ability to manage emotional experiences using a 24-item, four- point Likert scale (1 = Never, 4 = Always). The questionnaire yields two subscales: 1) adaptive emotion regulation (e.g. "Can modulate excitement in emotionally arousing situations", range 10-40 with higher scores representing more adaptive ER), which assesses situational appropriateness of affective displays, empathy and emotional self-awareness; and 2) lability/negativity (e.g. "Exhibits wide mood swings", range 14-56, with higher scores representing more lability/negativity), which assesses mood lability, lack of flexibility, dysregulated negative affect and inappropriate affective displays.

    Time frame: Pre and post treatment (prior to randomization, after 10 week wait list period if appropriate, and again after completion of 10 week treatment)

  2. Emotional Regulation Questionnaire - Child & Adolescent

    Child report of ER capacities The questionnaire consists of 10 items capturing two specific emotion regulation strategies, cognitive reappraisal and expressive suppression on a 7-point Likert scale, where 1 means "strongly disagree", 4 "neutral", and 7 means "strongly agree". Higher mean score on a subscale indicates that the strategy is more endorsed. The cognitive reappraisal scale has 6 items and the expressive suppression has 4 items.

    Time frame: Pre and post treatment (prior to randomization, after 10 week wait list period if appropriate, and again after completion of 10 week treatment)

  3. Child Behavior Checklist

    ODD subscale - six items on sub scale, scored by computer, reports T-scores; T-score below 60 is normal, 60-70 is borderline, \>70 is clinical range

    Time frame: Pre and post treatment (prior to randomization, after 10 week wait list period if appropriate, and again after completion of 10 week treatment)

07

Study locations

1 site
  • Ferkauf Graduate School of Psychology - Yeshiva University
    Bronx, New York 10461, United States
08

References and documents

Publications

  • Prout TA, Rice T, Chung H, Gorokhovsky Y, Murphy S, Hoffman L. Randomized controlled trial of Regulation Focused Psychotherapy for children: A manualized psychodynamic treatment for externalizing behaviors. Psychother Res. 2022 Jun;32(5):555-570. doi: 10.1080/10503307.2021.1980626. Epub 2021 Sep 28. PubMed 34583626 ↗

Related links

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 30, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03594253
Lead sponsor
Yeshiva University
Collaborators
The FAR Fund
Responsible party
Tracy Prout (Assistant Professor, Yeshiva University) — Principal investigator
First posted
Jul 20, 2018
Start date
Jan 1, 2017
Primary completion
Jun 30, 2020
Completion
Jun 30, 2020
Last update
Jan 30, 2023

Study contacts

Tracy A. Prout, PhD
principal investigator · Ferkauf Graduate School of Psychology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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