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Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment

Primary Purpose

Psychiatric Diagnosis

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Making Connections Intervention-Telehealth (MCI-T)
Treatment as usual (TAU)
Sponsored by
New York State Psychiatric Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psychiatric Diagnosis focused on measuring anxiety, depression, telehealth, behavioral problems

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Youth Sample

  1. Youth ages 12-18 years of age receiving an evaluation in the diagnostic evaluation service, the Diagnostic Evaluation and Stabilization Clinic (DESC), or another clinical service in the outpatient Child Behavioral Health Service at NewYork Presbyterian (NYP) - Morgan Stanley Children's Hospital (MSCH)/ NYP-MSCH.
  2. English speaking

Exclusion Criteria: Youth Sample

  1. Active Suicidal Ideation with current plan and/or intent that requires a higher level of care than outpatient treatment or treatment in DESC
  2. Diagnosis of intellectual disability

Inclusion Criteria: Clinician Sample

  1. Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC
  2. Clinician consent
  3. English or bilingual in English and Spanish

Exclusion Criteria: Clinician Sample

1. None

Sites / Locations

  • New York State Psychiatric Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

MCI-T

Arm Description

Participants are randomized to treatment as usual (TAU)

Participants are randomized to the Making Connections Intervention-Telehealth (MCI-T) plus treatment as usual (TAU)

Outcomes

Primary Outcome Measures

Change in the Working Alliance Inventory (WAI-S)
The Working Alliance Inventory (WAI-S) reported by both teen and clinician is a self-report measure used to assess three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 7-point scale ranging from 1 (never) to 7 (always) for the extent to which each of the given statements describes the youth's experience. A total alliance rating is calculated by summing the ratings of all 12 items and ranges from 12-84, with higher scores reflecting a more positive rating of working alliance. The WAI-S will be used to assess changes in working alliance between participants and clinicians through study completion at the 12-week follow-up assessment. The scale will be completed at week 1 about the prior 1 week, at week 6 about the prior 5 weeks, and at week 12 about the prior 6 weeks (post intervention).
Change in Barriers for Adolescent Seeking Health (BASH)
The Barriers for Adolescent Seeking Health (BASH) is a 37-item scale that measures adolescents' barriers to seeking help from mental health professionals. Items are rated on a 3-point scale ranging from 1 (not at all) to 3 (a great deal) for the extent to which and individual experiences help-seeking barriers. A total score is calculated by summing the ratings of all 37 items and ranges from 37-111, with higher scores indicating greater barriers to seeking help from a mental health professional. The BASH will be used to assess changes in adolescents' barriers to seeking help from mental health professionals through study completion at the 12-week follow-up assessment. The scale will be completed at baseline about prior lifetime experiences, at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks (post intervention).
Change in Attitudes toward Psychological Help-Seeking Scale (ATPHS)
The Attitudes toward Psychological Help-seeking Scale (ATPHS) is a 5-item scale that assesses stigma in relation to seeking help for psychological problems. Items are rated on a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree) for the extent to which an individual . A total score is calculated by summing the ratings of all 5 items and ranges from 0-20, with higher scores indicating more negative attitudes toward seeking psychological help. The ATPHS will be used to assess changes in youth's attitudes toward seeking psychological help through study completion at 12 week follow-up. The scale will be completed at baseline about the participan's lifetime, at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks (post intervention).

Secondary Outcome Measures

Change in Progress of Treatment (POT)
The Progress of Treatment Questionnaire (POT) is a 5-item questionnaire that assesses patient progress throughout treatment. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much) for the extent to which the clinician observes patient progress. A total score is calculated by summing the ratings of all 5 items and ranges from 5-25, with higher scores indicating greater patient progress. The POT will be used to assess changes in participants' progress of treatment through the study completion at the 12-week follow-up assessment. The questionnaire will be completed at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks.
Change in Client Satisfaction (CSQ-8)
The Client Satisfaction (CSQ-8) is an 8-item self-report questionnaire that measures client satisfaction with psychological services. Items are rated on various different Likert scales as well as through open-ended questions for the extent to which an individual is satisfied with the psychological services they are receiving. A total score is calculated by summing the ratings of all 8 items and accounting for open-ended responses, with higher scores indicating greater client satisfaction. The CSQ-8 will be used to assess changes in participants' satisfaction with the psychological services they are receiving through the study completion at the 12-week follow-up assessment. The questionnaire will be completed at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks.

Full Information

First Posted
June 9, 2021
Last Updated
July 25, 2022
Sponsor
New York State Psychiatric Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04931927
Brief Title
Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment
Official Title
Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Terminated
Why Stopped
This study has been terminated due to a change in study design. The study is no longer a RCT.
Study Start Date
November 8, 2021 (Actual)
Primary Completion Date
July 12, 2022 (Actual)
Study Completion Date
July 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
New York State Psychiatric Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In the present study, investigators aim to (1) adapt the Making Connections Intervention (MCI) as an intervention to address telehealth engagement and examine whether this targeted intervention can improve youth engagement in telehealth treatment; and (2) assess attitudes towards help-seeking and therapeutic alliance from both the youth and clinician viewpoint to examine the impact of these factors on engagement in telemental health treatment. Forty adolescent participants ages 12-18 will be randomized to either telehealth treatment as usual (TAU) plus the telehealth Making Connections Intervention (MCI-T) engagement session or telehealth TAU alone and followed for 12 weeks from baseline assessment. All clinicians will receive training in the MCI-T intervention and provide either MCI-T + usual care or usual care only depending on the condition to which the adolescents are randomized. All evaluations and therapy sessions will be done over telehealth platform.
Detailed Description
Clinicians who participate in the study may be assigned more than one study case, and therefore will complete measures on each study case. All of the clinicians will receive training in the Making Connections Intervention-Telehealth (MCI-T) intervention. The clinicians will deliver the intervention based on the random assignment of the adolescent participants to a treatment arm. When clinicians provide care to adolescents randomized to the MCI-T condition, they will participate in a monthly consultation over telehealth to review cases to promote adherence and fidelity to the treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychiatric Diagnosis
Keywords
anxiety, depression, telehealth, behavioral problems

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
Participants are randomized to treatment as usual (TAU)
Arm Title
MCI-T
Arm Type
Experimental
Arm Description
Participants are randomized to the Making Connections Intervention-Telehealth (MCI-T) plus treatment as usual (TAU)
Intervention Type
Behavioral
Intervention Name(s)
Making Connections Intervention-Telehealth (MCI-T)
Intervention Description
Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) [MCI-T +TAU]
Intervention Type
Behavioral
Intervention Name(s)
Treatment as usual (TAU)
Intervention Description
Telehealth treatment as usual without the single session telehealth engagement intervention
Primary Outcome Measure Information:
Title
Change in the Working Alliance Inventory (WAI-S)
Description
The Working Alliance Inventory (WAI-S) reported by both teen and clinician is a self-report measure used to assess three key aspects of the therapeutic alliance: (a) agreement on the tasks of therapy, (b) agreement on the goals of therapy and (c) development of an affective bond. Items are rated on a 7-point scale ranging from 1 (never) to 7 (always) for the extent to which each of the given statements describes the youth's experience. A total alliance rating is calculated by summing the ratings of all 12 items and ranges from 12-84, with higher scores reflecting a more positive rating of working alliance. The WAI-S will be used to assess changes in working alliance between participants and clinicians through study completion at the 12-week follow-up assessment. The scale will be completed at week 1 about the prior 1 week, at week 6 about the prior 5 weeks, and at week 12 about the prior 6 weeks (post intervention).
Time Frame
week 1, week 6, week 12 (post intervention)
Title
Change in Barriers for Adolescent Seeking Health (BASH)
Description
The Barriers for Adolescent Seeking Health (BASH) is a 37-item scale that measures adolescents' barriers to seeking help from mental health professionals. Items are rated on a 3-point scale ranging from 1 (not at all) to 3 (a great deal) for the extent to which and individual experiences help-seeking barriers. A total score is calculated by summing the ratings of all 37 items and ranges from 37-111, with higher scores indicating greater barriers to seeking help from a mental health professional. The BASH will be used to assess changes in adolescents' barriers to seeking help from mental health professionals through study completion at the 12-week follow-up assessment. The scale will be completed at baseline about prior lifetime experiences, at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks (post intervention).
Time Frame
baseline, week 6, week 12 (post intervention)
Title
Change in Attitudes toward Psychological Help-Seeking Scale (ATPHS)
Description
The Attitudes toward Psychological Help-seeking Scale (ATPHS) is a 5-item scale that assesses stigma in relation to seeking help for psychological problems. Items are rated on a 4-point scale ranging from 0 (strongly disagree) to 3 (strongly agree) for the extent to which an individual . A total score is calculated by summing the ratings of all 5 items and ranges from 0-20, with higher scores indicating more negative attitudes toward seeking psychological help. The ATPHS will be used to assess changes in youth's attitudes toward seeking psychological help through study completion at 12 week follow-up. The scale will be completed at baseline about the participan's lifetime, at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks (post intervention).
Time Frame
baseline, week 6, week 12
Secondary Outcome Measure Information:
Title
Change in Progress of Treatment (POT)
Description
The Progress of Treatment Questionnaire (POT) is a 5-item questionnaire that assesses patient progress throughout treatment. Items are rated on a 5-point scale ranging from 1 (not at all) to 5 (very much) for the extent to which the clinician observes patient progress. A total score is calculated by summing the ratings of all 5 items and ranges from 5-25, with higher scores indicating greater patient progress. The POT will be used to assess changes in participants' progress of treatment through the study completion at the 12-week follow-up assessment. The questionnaire will be completed at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks.
Time Frame
week 6, week 12
Title
Change in Client Satisfaction (CSQ-8)
Description
The Client Satisfaction (CSQ-8) is an 8-item self-report questionnaire that measures client satisfaction with psychological services. Items are rated on various different Likert scales as well as through open-ended questions for the extent to which an individual is satisfied with the psychological services they are receiving. A total score is calculated by summing the ratings of all 8 items and accounting for open-ended responses, with higher scores indicating greater client satisfaction. The CSQ-8 will be used to assess changes in participants' satisfaction with the psychological services they are receiving through the study completion at the 12-week follow-up assessment. The questionnaire will be completed at week 6 about the prior 6 weeks, and at week 12 about the prior 6 weeks.
Time Frame
week 6, week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Youth Sample Youth ages 12-18 years of age receiving an evaluation in the diagnostic evaluation service, the Diagnostic Evaluation and Stabilization Clinic (DESC), or another clinical service in the outpatient Child Behavioral Health Service at NewYork Presbyterian (NYP) - Morgan Stanley Children's Hospital (MSCH)/ NYP-MSCH. English speaking Exclusion Criteria: Youth Sample Active Suicidal Ideation with current plan and/or intent that requires a higher level of care than outpatient treatment or treatment in DESC Diagnosis of intellectual disability Inclusion Criteria: Clinician Sample Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC Clinician consent English or bilingual in English and Spanish Exclusion Criteria: Clinician Sample 1. None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura Mufson, Ph.D.
Organizational Affiliation
Columbia University/NYSPI
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York State Psychiatric Institute
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment

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