Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study

Completed

• Conditions: Emotional Disorder
• Interventions: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents

• Registration Number: NCT04792151
• Lead Sponsor: University of Colorado, Denver

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-15
• Study First Submitted QC: 2021-03-08
• Study First Posted: 2021-03-10
• Study Start: 2021-04-15
• Primary Completion: 2022-04-25
• Study Completion: 2022-04-25
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-18
• Last Update Posted: 2022-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 304

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PHP Youth	Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents	Youth ages 6-17 receiving standard of care treatment (i.e., transdiagnostic intervention for emotional disorders) in a partial hospitalization program

Primary Outcome Measures

Name	Time	Method
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	Baseline, up to 2 month	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.
Change in functional impairment, as measured by the Brief Impairment Scale (BIS)	Baseline, up to 2 month	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.
Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at post-treatment	2 month	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.
Change in depression symptoms, as measured by the PROMIS Pediatric and Parent Proxy Depressive Symptoms Short Forms, Version 2.0	Baseline, up to 2 month	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.
Change in distress intolerance, as measured by the Distress Intolerance Index for Youth (DIIY)	Baseline, up to 2 month	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.
Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at 1 Month follow up	2 month	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.
Change in emotional reactivity, as measured by the Emotion Dysregulation Inventory--Reactivity Short Form (EDI-R)	Baseline, up to 2 month	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.
Change in anxiety sensitivity, as measured by the Childhood Anxiety Sensitivity Index (CASI)	Baseline, up to 2 month	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.
Change in symptoms of disruptive and oppositional behavior, as measured by the Disruptive Behavior Rating Scale (DBRS)	Baseline, up to 2 month	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.

Secondary Outcome Measures

Name	Time	Method
Fidelity to the transdiagnostic treatment protocol, as measured by the UP-C Adherence and Competency Checklist, Observer and Clinician Self-Report version	Up to 2 months	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).
Fidelity to the transdiagnostic treatment protocol, as measured by the UP-A Adherence and Competency Checklist, Observer and Clinician Self-Report version	Up to 2 months	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).
Change in positive and negative parenting behaviors, as measured by the Alabama Parenting Questionnaire--Short Form (APQ-S)	Baseline, up to 2 month	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.
Change in youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale	Baseline, up to 2 month	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.
Number of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)	Up to 2 months	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.
Type of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)	Up to 2 months	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.
Change in parental accommodation of youth emotional disorder symptoms, as measured by the Family Accommodation Scale (FAS-E), adapted for youth emotional disorders symptoms	Baseline, up to 2 month	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.
Change in parents' perceived self-efficacy in parenting their child, as measured by the Parenting Sense of Competence--Parenting Self Efficacy Scale (PSOC)	Baseline, up to 2 month	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.
Change in youth cognitive reappraisal, as measured by the Emotion Regulation Questionnaire for Children and Adolescents--Reappraisal Scale (ERQ-CA)	Baseline, up to 2 month	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.

Trial Locations

Locations (1)

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States