Evaluation of Regulation Focused Psychotherapy for Children (RFP-C)
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|ClinicalTrials.gov Identifier: NCT03594253|
Recruitment Status : Active, not recruiting
First Posted : July 20, 2018
Last Update Posted : April 21, 2020
|Condition or disease||Intervention/treatment||Phase|
|Oppositional Defiant Disorder Oppositional Defiant Disorder in Children||Behavioral: Regulation Focused Psychotherapy for Children||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|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)|
|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|
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.
- 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
- 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.
- 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.
- 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
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
|United States, New York|
|Ferkauf Graduate School of Psychology - Yeshiva University|
|Bronx, New York, United States, 10461|
|Principal Investigator:||Tracy A. Prout, PhD||Ferkauf Graduate School of Psychology|