Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study

NCT04792151 | Completed

• 1 other identifier: 20-2566
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Disorder

Outcome Measures

Primary Outcomes (9)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (9)

• 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

• Change in positive and negative parenting behaviors, as measured by the Alabama Parenting Questionnaire--Short Form (APQ-S)

  Baseline, up to 2 month

• 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

• 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

• Change in youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale

  Baseline, up to 2 month

Study Arms (1)

PHP Youth

Youth ages 6-17 receiving standard of care treatment (i.e., transdiagnostic intervention for emotional disorders) in a partial hospitalization program

Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents

Interventions

Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents BEHAVIORAL

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.

PHP Youth

Eligibility Criteria

• Age: 6 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants will be youth and parents recruited from the partial hospitalization program at Children's Hospital Colorado.

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• American Psychological Foundation: collaborator
• Children's Hospital Colorado: collaborator

Study Sites (1)

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Study Officials

• Sarah M Kennedy, PhD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2021
• First Posted: March 10, 2021
• Study Start: April 15, 2021
• Primary Completion: April 25, 2022
• Study Completion: April 25, 2022
• Last Updated: August 19, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Data will be available immediately following publication and ending 5 years after publication.
• Access Criteria: Researchers who provide a methodologically sound proposal or reason for accessing the data will be granted access.

Locations

US (1)