Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03594253
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : April 21, 2020
Sponsor:
Collaborator:
The FAR Fund
Information provided by (Responsible Party):
Tracy Prout, Yeshiva University

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.

Condition or disease Intervention/treatment Phase
Oppositional Defiant Disorder Oppositional Defiant Disorder in Children Behavioral: Regulation Focused Psychotherapy for Children Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Randomized Control Trial of Regulation Focused Psychotherapy for Children (RFP-C) With Externalizing Behaviors
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Arm Intervention/treatment
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
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).
Other Name: RFP-C

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.



Primary Outcome Measures :
  1. Oppositional Defiant Disorder Rating Scale [ 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) ]
    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 :
  1. Emotion Regulation Checklist [ 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) ]

    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.


  2. Emotional Regulation Questionnaire - Child & Adolescent [ 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) ]

    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.


  3. Child Behavior Checklist [ 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) ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   5 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03594253


Locations
Layout table for location information
United States, New York
Ferkauf Graduate School of Psychology - Yeshiva University
Bronx, New York, United States, 10461
Sponsors and Collaborators
Yeshiva University
The FAR Fund
Investigators
Layout table for investigator information
Principal Investigator: Tracy A. Prout, PhD Ferkauf Graduate School of Psychology
Layout table for additonal information
Responsible Party: Tracy Prout, Assistant Professor, Yeshiva University
ClinicalTrials.gov Identifier: NCT03594253    
Other Study ID Numbers: 2016-6595
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: April 21, 2020
Last Verified: April 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Tracy Prout, Yeshiva University:
oppositional defiant disorder
regulation focused psychotherapy for children
emotion regulation
psychodynamic psychotherapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Disease
Attention Deficit and Disruptive Behavior Disorders
Pathologic Processes
Neurodevelopmental Disorders
Mental Disorders