AzTrials
AzTrials

Oppositional Defiant DisorderRFP-CNCT03594253

Evaluation of Regulation Focused Psychotherapy for Children

A study testing Regulation Focused Psychotherapy for Children in people with Oppositional Defiant Disorder and Oppositional Defiant Disorder in Children, run by Yeshiva University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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 more about this study

Who is it for?
Ages 5 to 12 years
What is being tested?
Regulation Focused Psychotherapy for Children
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteUnited States
Study dates
1 Jan 2017to 30 Jun 2020
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 5 to 12 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Ferkauf Graduate School of Psychology - Yeshiva University

    The Bronx, New York, 10461

Other trials in United States

About this study

Official title: Randomized Control Trial of Regulation Focused Psychotherapy for Children (RFP-C) With Externalizing Behaviors

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.

Being tested
Regulation Focused Psychotherapy for Children
Keywords
oppositional defiant disorder, regulation focused psychotherapy for children, emotion regulation, psychodynamic psychotherapy
Medical subject headings
Oppositional Defiant Disorder, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Regulation Focused Psychotherapy for ChildrenBehavioural

    Also called RFP-C

    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).

Study groups in NCT03594253
Study groupRoleWhat they receive
RFP-CExperimentalRegulation 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.
Receives: Behavioral: Regulation Focused Psychotherapy for Children
Wait List controlNo interventionParticipants 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 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)
  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.

    Measured: 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.

    Measured: 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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start1 Jan 2017
  3. Primary completion30 Jun 2020
  4. Study completion30 Jun 2020

Resources

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
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)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03594253
Sponsor's protocol ID
2016-6595
Acronym
RFP-C
Status last verified
Jan 2023
First submitted
23 Feb 2018
Last updated
30 Jan 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Regulation Focused Psychotherapy for Children in people with Oppositional Defiant Disorder and Oppositional Defiant Disorder in Children, run by Yeshiva University at 1 site in United States.

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 5 inclusion and 2 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 30 Jan 2023. 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 United States. 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?

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)). 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 NCT03594253, 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 30 Jan 2023.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in