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Evaluation of Regulation Focused Psychotherapy for Children (RFP-C)

Primary Purpose

Oppositional Defiant Disorder, Oppositional Defiant Disorder in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Regulation Focused Psychotherapy for Children
Sponsored by
Yeshiva University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Oppositional Defiant Disorder focused on measuring oppositional defiant disorder, regulation focused psychotherapy for children, emotion regulation, psychodynamic psychotherapy

Eligibility Criteria

5 Years - 12 Years (Child)All SexesDoes not accept healthy volunteers

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:

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

Sites / Locations

  • Ferkauf Graduate School of Psychology - Yeshiva University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

RFP-C

Wait List control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
February 23, 2018
Last Updated
January 26, 2023
Sponsor
Yeshiva University
Collaborators
The FAR Fund
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1. Study Identification

Unique Protocol Identification Number
NCT03594253
Brief Title
Evaluation of Regulation Focused Psychotherapy for Children
Acronym
RFP-C
Official Title
Randomized Control Trial of Regulation Focused Psychotherapy for Children (RFP-C) With Externalizing Behaviors
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
June 30, 2020 (Actual)
Study Completion Date
June 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yeshiva University
Collaborators
The FAR Fund

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oppositional Defiant Disorder, Oppositional Defiant Disorder in Children
Keywords
oppositional defiant disorder, regulation focused psychotherapy for children, emotion regulation, psychodynamic psychotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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. 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 (Rice & Hoffman, 2014). Externalizing behaviors are 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. This 16-session (plus four parent sessions) psychotherapy method 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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
RFP-C
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Regulation Focused Psychotherapy for Children
Other Intervention Name(s)
RFP-C
Intervention Description
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).
Primary Outcome Measure Information:
Title
Oppositional Defiant Disorder Rating Scale
Description
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 Outcome Measure Information:
Title
Emotion Regulation Checklist
Description
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)
Title
Emotional Regulation Questionnaire - Child & Adolescent
Description
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)
Title
Child Behavior Checklist
Description
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: Active Administration for Children's Services (ACS)/Child Protective Services (CPS) involvement Severe autism spectrum disorder
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tracy A. Prout, PhD
Organizational Affiliation
Ferkauf Graduate School of Psychology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ferkauf Graduate School of Psychology - Yeshiva University
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
34583626
Citation
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.
Results Reference
derived
Links:
URL
https://www.centerforrfp.org/
Description
Study Website

Learn more about this trial

Evaluation of Regulation Focused Psychotherapy for Children

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