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Clinical Trials/NCT04792151
NCT04792151
Completed
Not Applicable

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

University of Colorado, Denver1 site in 1 country304 target enrollmentApril 15, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Disorder
Sponsor
University of Colorado, Denver
Enrollment
304
Locations
1
Primary Endpoint
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
Status
Completed
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 15, 2021
End Date
April 25, 2022
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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)

Time Frame: 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

Time Frame: 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

Time Frame: 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)

Time Frame: 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

Time Frame: 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)

Time Frame: 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)

Time Frame: 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)

Time Frame: 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 Outcomes

  • 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)
  • 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)
  • 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 youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale(Baseline, up to 2 month)
  • Number of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)(Up to 2 months)
  • Type of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)(Up to 2 months)
  • 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 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)

Study Sites (1)

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