NCT03594253

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 23, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 20, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

January 30, 2023

Status Verified

January 1, 2023

Enrollment Period

3.5 years

First QC Date

February 23, 2018

Last Update Submit

January 26, 2023

Conditions

Keywords

oppositional defiant disorderregulation focused psychotherapy for childrenemotion regulationpsychodynamic psychotherapy

Outcome Measures

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

    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 (3)

  • Emotion Regulation Checklist

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

  • Emotional Regulation Questionnaire - Child & Adolescent

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

  • Child Behavior Checklist

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

Study Arms (2)

RFP-C

EXPERIMENTAL

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

Wait List control

NO INTERVENTION

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

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
RFP-C

Eligibility Criteria

Age5 Years - 12 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ferkauf Graduate School of Psychology - Yeshiva University

The Bronx, New York, 10461, United States

Location

Related Publications (1)

  • 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.

Related Links

MeSH Terms

Conditions

Oppositional Defiant DisorderEmotional Regulation

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersSelf-ControlSocial BehaviorBehavior

Study Officials

  • Tracy A. Prout, PhD

    Ferkauf Graduate School of Psychology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 23, 2018

First Posted

July 20, 2018

Study Start

January 1, 2017

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

January 30, 2023

Record last verified: 2023-01

Locations