Clinical trial NCT04792151: Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study
Official title: PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emotional Disorder
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: American Psychological Foundation
name: Children's Hospital Colorado
First posted: 2021-03-10
Enrollment: 304
Sex: ALL
Minimum age (years): 6
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be youth and parents recruited from the partial hospitalization program at Children's Hospital Colorado.

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.


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

Primary outcomes:
measure: Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at post-treatment
timeFrame: 2 month
measure: Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at 1 Month follow up
timeFrame: 2 month
measure: 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
timeFrame: Baseline, up to 2 month
measure: Change in depression symptoms, as measured by the PROMIS Pediatric and Parent Proxy Depressive Symptoms Short Forms, Version 2.0
timeFrame: Baseline, up to 2 month
measure: Change in emotional reactivity, as measured by the Emotion Dysregulation Inventory--Reactivity Short Form (EDI-R)
timeFrame: Baseline, up to 2 month
measure: Change in functional impairment, as measured by the Brief Impairment Scale (BIS)
timeFrame: Baseline, up to 2 month
measure: Change in symptoms of disruptive and oppositional behavior, as measured by the Disruptive Behavior Rating Scale (DBRS)
timeFrame: Baseline, up to 2 month
measure: Change in anxiety sensitivity, as measured by the Childhood Anxiety Sensitivity Index (CASI)
timeFrame: Baseline, up to 2 month
measure: Change in distress intolerance, as measured by the Distress Intolerance Index for Youth (DIIY)
timeFrame: Baseline, up to 2 month
Secondary outcomes:
measure: Change in parental accommodation of youth emotional disorder symptoms, as measured by the Family Accommodation Scale (FAS-E), adapted for youth emotional disorders symptoms
timeFrame: Baseline, up to 2 month
measure: Change in positive and negative parenting behaviors, as measured by the Alabama Parenting Questionnaire--Short Form (APQ-S)
timeFrame: Baseline, up to 2 month
measure: Change in parents' perceived self-efficacy in parenting their child, as measured by the Parenting Sense of Competence--Parenting Self Efficacy Scale (PSOC)
timeFrame: Baseline, up to 2 month
measure: Change in youth cognitive reappraisal, as measured by the Emotion Regulation Questionnaire for Children and Adolescents--Reappraisal Scale (ERQ-CA)
timeFrame: Baseline, up to 2 month
measure: Change in youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale
timeFrame: Baseline, up to 2 month
measure: Number of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)
timeFrame: Up to 2 months
measure: Type of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)
timeFrame: Up to 2 months
measure: Fidelity to the transdiagnostic treatment protocol, as measured by the UP-C Adherence and Competency Checklist, Observer and Clinician Self-Report version
timeFrame: Up to 2 months
measure: Fidelity to the transdiagnostic treatment protocol, as measured by the UP-A Adherence and Competency Checklist, Observer and Clinician Self-Report version
timeFrame: Up to 2 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Sarah M Kennedy, PhD
role: PRINCIPAL_INVESTIGATOR
References: