Emotional DisorderPHP TIESNCT04792151
Youth PHP Pilot Transdiagnostic Treatment Implementation and Effectiveness Study
An observational study of Emotional Disorder, run by University of Colorado, Denver at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 6 to 85 years
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 304 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2021to 25 Apr 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants will be youth and parents recruited from the partial hospitalization program at Children's Hospital Colorado.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program
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
- Being tested
- Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| PHP Youth | Youth ages 6-17 receiving standard of care treatment (i.e., transdiagnostic intervention for emotional disorders) in a partial hospitalization program Receives: Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and Adolescents |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
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.
Measured: Baseline, up to 2 month
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: Baseline, up to 2 month
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.
Measured: Baseline, up to 2 month
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.
Measured: Up to 2 months
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.
Measured: Up to 2 months
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).
Measured: 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
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).
Measured: Up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2021
- Study start15 Apr 2021
- Primary completion25 Apr 2022
- Study completion25 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisorderStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- American Psychological Foundation, Children's Hospital Colorado
- Responsible party
- Sponsor
- Investigators
- Sarah M Kennedy, PhD, Principal investigator, University of Colorado, Denver
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04792151
- Sponsor's protocol ID
- 20-2566
- Acronym
- PHP TIES
- Status last verified
- Aug 2022
- First submitted
- 15 Jan 2021
- Last updated
- 19 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie results reported in any published studies will be shared upon publication, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHP TIES: Pilot Transdiagnostic Treatment Implementation and Effectiveness Study for Youth Emotional Disorders in a Partial Hospitalization Program
- ClinicalTrials.gov ID
- NCT04792151
- Acronym / sponsor ID
- PHP TIES / 20-2566
- Conditions
- Emotional Disorder
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- American Psychological Foundation, Children's Hospital Colorado
- Study start
- 15 Apr 2021 (actual)
- Primary completion
- 25 Apr 2022 (actual)
- Study completion
- 25 Apr 2022 (actual)
- First posted
- 10 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PHP Youth | – | Behavioral: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsYouth ages 6-17 receiving standard of care treatment (i.e., transdiagnostic intervention for emotional disorders) in a partial hospitalization program |
Who may qualify
- Ages
- 6 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be youth and parents recruited from the partial hospitalization program at Children's Hospital Colorado.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- they are a ward of the state
- are not enrolled in the Children's Hospital Colorado PHP program.
- --they are not providing clinical services through the Children's Hospital Colorado PHP program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unified Protocol for Transdiagnostic Treatment of Emotional Disorders in Children and AdolescentsThe 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. | Behavioural | PHP Youth |
Primary outcome
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.
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 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 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 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 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.
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.
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 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.
9 secondary outcomes
Change in parental accommodation of youth emotional disorder symptoms, as measured by the Family Accommodation Scale (FAS-E), adapted for youth emotional disorders symptoms
Time frame: Baseline, up to 2 month
Change in positive and negative parenting behaviors, as measured by the Alabama Parenting Questionnaire--Short Form (APQ-S)
Time frame: 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)
Time frame: 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)
Time frame: Baseline, up to 2 month
Change in youth perceived self-efficacy, as measured by the PROMIS Self Efficacy scale
Time frame: Baseline, up to 2 month
Number of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)
Time frame: Up to 2 months
Type of modifications made to the transdiagnostic treatment protocol, as measured by the Modification and Adaptation Checklist (MAC)
Time frame: Up to 2 months
Fidelity to the transdiagnostic treatment protocol, as measured by the UP-C Adherence and Competency Checklist, Observer and Clinician Self-Report version
Time frame: 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
Time frame: Up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie results reported in any published studies will be shared upon publication, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sarah M Kennedy, PhD principal investigator
University of Colorado, Denver
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emotional Disorder, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Client satisfaction with treatment, as measured by the Client Satisfaction Questionnaire-8 (CSQ-8) at post-treatment (time frame: 2 month). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2022.