Evaluation of Regulation Focused Psychotherapy for Children

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Brief Title

Evaluation of Regulation Focused Psychotherapy for Children

Official Title

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

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.
    


Study Type

Interventional


Primary Outcome

Oppositional Defiant Disorder Rating Scale

Secondary Outcome

 Emotion Regulation Checklist

Condition

Oppositional Defiant Disorder

Intervention

Regulation Focused Psychotherapy for Children

Study Arms / Comparison Groups

 RFP-C
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

40

Start Date

January 1, 2017

Completion Date

June 30, 2020

Primary Completion Date

June 30, 2020

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
      

Gender

All

Ages

5 Years - 12 Years

Accepts Healthy Volunteers

No

Contacts

Tracy A. Prout, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03594253

Organization ID

2016-6595


Responsible Party

Principal Investigator

Study Sponsor

Yeshiva University

Collaborators

 The FAR Fund

Study Sponsor

Tracy A. Prout, PhD, Principal Investigator, Ferkauf Graduate School of Psychology


Verification Date

April 2020