Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study

Emotional Disorder Clinical Trial

— PHP TIES  

Official title:

PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04792151
• Other study ID #: 20-2566
• Status: Completed
• Start date: April 15, 2021
• Est. completion date: April 25, 2022

Study information

• Verified date: August 2022
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to examine patient effectiveness outcomes of a transdiagnostic treatment for youth emotional disorders, implemented in a partial hospitalization program (PHP). Participants will be youth between ages 6 to 17 and their families, as well as clinicians, participating in the PHP program at Children's Hospital Colorado. Additionally, the research team will study modifications to the transdiagnostic intervention that are required to feasibly and effectively deliver it in a PHP setting.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 304
• Est. completion date: April 25, 2022
• Est. primary completion date: April 25, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 85 Years

Eligibility

Inclusion Criteria:

Inclusion criteria for patient participant involves:

• youth between the ages of 6 and 17

• participation in treatment in the Children's Hospital Colorado (CHCO) PHP program

• presence of at least one caregiver available and willing to participate in the study.

Inclusion criteria for clinician participants involves:

--psychologist, licensed master's-level clinician (i.e., "behavioral health clinician"), or unlicensed "behavioral health specialist" providing clinical services through the CHCO Partial Hospitalization Program during the period of study enrollment

Exclusion Criteria:

Patients will be excluded from the study if:

• they are a ward of the state

• are not enrolled in the Children's Hospital Colorado PHP program.

Clinicians will be excluded from the study if:

--they are not providing clinical services through the Children's Hospital Colorado PHP program

Related Conditions & MeSH terms

• Emotional Disorder
• Mood Disorders

Intervention

Behavioral:
• Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
The Unified Protocols for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents (UP-C and UP-A) are transdiagnostic, behavioral interventions for youth with emotional disorders, including anxiety, depression, obsessive-compulsive disorders, and irritability.

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado

Sponsors (3)

Lead Sponsor	Collaborator
University of Colorado, Denver	American Psychological Foundation, Children's Hospital Colorado

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at post-treatment	The CSQ-8 is an 8-item, self and parent-report measure of satisfaction with treatment services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with treatment services.	2 month
Primary	Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at 1 Month follow up	The CSQ-8 is an 8-item, self and parent-report measure of satisfaction with treatment services. Total scores range from 8 to 32, with higher scores indicating greater satisfaction with treatment services.	2 month
Primary	Change in anxiety symptoms, as measured by the Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric and Parent Proxy Anxiety Short Forms, Version 2.0	The PROMIS Pediatric and Parent Proxy Anxiety Short Form, Version 2.0 is an 8-item measuring assessing anxiety symptoms in youth. Total scores range from 8 to 40, with higher scores indicating greater anxiety symptoms.	Baseline, up to 2 month
Primary	Change in depression symptoms, as measured by the PROMIS Pediatric and Parent Proxy Depressive Symptoms Short Forms, Version 2.0	The PROMIS Pediatric and Parent Depressive Symptoms Short Form, Version 2.0 is a 6-item measuring assessing depressive symptoms in youth. Total scores range from 6 to 30, with higher scores indicating greater anxiety symptoms.	Baseline, up to 2 month
Primary	Change in emotional reactivity, as measured by the Emotion Dysregulation Inventory--Reactivity Short Form (EDI-R)	The EDI-R is a 7-item, parent report measure of emotional reactivity in youth. Total scores range from 0 to 35, with higher scores indicating greater emotional reactivity.	Baseline, up to 2 month
Primary	Change in functional impairment, as measured by the Brief Impairment Scale (BIS)	The BIS is a 23-item, parent report measure of functional impairment related to psychiatric symptoms in youth. Total scores range from 0 to 69, with higher scores indicating greater functional impairment.	Baseline, up to 2 month
Primary	Change in symptoms of disruptive and oppositional behavior, as measured by the Disruptive Behavior Rating Scale (DBRS)	The DBRS is an 8-item, parent report measure assessing symptoms of disruptive behaviors/oppositional defiant disorder in youth. Total scores range from 0 to 24, with higher scores indicating more disruptive/oppositional behaviors.	Baseline, up to 2 month
Primary	Change in anxiety sensitivity, as measured by the Childhood Anxiety Sensitivity Index (CASI)	The CASI is an 18-item self-report measure assessing fear of physiological symptoms of anxiety in youth. Total scores range from 18 to 56, with higher scores indicating greater anxiety sensitivity.	Baseline, up to 2 month
Primary	Change in distress intolerance, as measured by the Distress Intolerance Index for Youth (DIIY)	The DIIY is a 10-item, self and parent-report measure assessing youth perceived inability to tolerate negative emotional states and experiential discomfort. Total scores range from 10 to 50, with higher scores indicating greater distress intolerance.	Baseline, up to 2 month
Secondary	Change in parental accommodation of youth emotional disorder symptoms, as measured by the Family Accommodation Scale (FAS-E), adapted for youth emotional disorders symptoms	The FAS-E is a 9-item parent-report measure assessing family accommodation of emotions. Total scores range from 0 to 36, with higher scores indicating greater parent accommodation of emotion.	Baseline, up to 2 month
Secondary	Change in positive and negative parenting behaviors, as measured by the Alabama Parenting Questionnaire--Short Form (APQ-S)	The APQ-S is a 9-item, parent-report measure that yields three subscales ("Positive Parenting;" "Inconsistent Discipline," and "Poor Supervision"). Scores on each subscale range from 3 to 15. Higher scores on the Positive Parenting subscale indicate greater use of positive parenting strategies, higher scores on the Inconsistent Discipline scale indicate more inconsistent use of discipline techniques, and higher scores on the Poor Supervision scale indicate poorer parental supervision of youth.	Baseline, up to 2 month
Secondary	Change in parents' perceived self-efficacy in parenting their child, as measured by the Parenting Sense of Competence--Parenting Self Efficacy Scale (PSOC)	The PSOC is a 7-item measure assessing parents' perceived parenting self-efficacy. Total scores range from 7 to 42, with higher scores indicating greater parenting self-efficacy.	Baseline, up to 2 month
Secondary	Change in youth cognitive reappraisal, as measured by the Emotion Regulation Questionnaire for Children and Adolescents--Reappraisal Scale (ERQ-CA)	The ERQ-CA Reappraisal subscale is a 6-item measure assessing youth reappraisal, or the extent to which youth are able to change their thinking about situations that elicit emotions. Total scores range from 0 to 24, with higher scores indicating greater use of reappraisal.	Baseline, up to 2 month
Secondary	Change in youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale	The PROMIS Self Efficacy scale is a 10-item, self-report measure assessing general self-efficacy, or an individual's belief in their capacity to manage daily stressors and have control over meaningful events. Total scores range from 10 to 50, with higher scores indicating greater perceived self-efficacy.	Baseline, up to 2 month
Secondary	Number of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)	The MAC is a 13-item checklist (including clinician self-report and observer report versions) intended to assist in tracking modifications made to an evidence-based treatment protocol. Adaptations and modifications will be tracked during 25% of treatment sessions. Total number of modifications will be summed.	Up to 2 months
Secondary	Type of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)	The MAC is a 13-item checklist (including clinician self-report and observer report versions) intended to assist in tracking modifications made to an evidence-based treatment protocol. Adaptations and modifications will be tracked during 25% of treatment sessions. Types of modifications will be summarized categorically, and number of modifications of each type will be reported.	Up to 2 months
Secondary	Fidelity to the transdiagnostic treatment protocol, as measured by the UP-C Adherence and Competency Checklist, Observer and Clinician Self-Report version	The UP-C Adherence and Competency Checklist is a tool designed to facilitate tracking of the delivery of core treatment components during therapy sessions. 25% of group therapy sessions will be coded by an observer and by clinicians delivering the intervention, and proportion of core elements delivered will be calculator. Inter-rater reliability among reporters will also be calculated. Score range: 0-170 (scored on a three-point scale) Higher scores indicate greater therapist competence and adherence to the treatment protocol. Scores are represented as percent adherence rather than total (e.g., 90% adherent).	Up to 2 months
Secondary	Fidelity to the transdiagnostic treatment protocol, as measured by the UP-A Adherence and Competency Checklist, Observer and Clinician Self-Report version	The UP-A Adherence and Competency Checklist is a tool designed to facilitate tracking of the delivery of core treatment components during therapy sessions. 25% of group therapy sessions will be coded by an observer and by clinicians delivering the intervention, and proportion of core elements delivered will be calculator. Inter-rater reliability among reporters will also be calculated. Score range: 0-170 (scored on a three-point scale). Higher scores indicate greater therapist competence and adherence to the treatment protocol. Scores are represented as percent adherence rather than total (e.g., 90% adherent).	Up to 2 months