- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04931927
Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment
July 25, 2022 updated by: Laura Mufson, New York State Psychiatric Institute
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
14
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10032
- New York State Psychiatric Institute
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Control
Participants are randomized to treatment as usual (TAU)
|
Telehealth treatment as usual without the single session telehealth engagement intervention
|
Experimental: MCI-T
Participants are randomized to the Making Connections Intervention-Telehealth (MCI-T) plus treatment as usual (TAU)
|
Telehealth treatment as usual without the single session telehealth engagement intervention
Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) [MCI-T +TAU]
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in the Working Alliance Inventory (WAI-S)
Time Frame: week 1, week 6, week 12 (post intervention)
|
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).
|
week 1, week 6, week 12 (post intervention)
|
Change in Barriers for Adolescent Seeking Health (BASH)
Time Frame: baseline, week 6, week 12 (post intervention)
|
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).
|
baseline, week 6, week 12 (post intervention)
|
Change in Attitudes toward Psychological Help-Seeking Scale (ATPHS)
Time Frame: baseline, week 6, week 12
|
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).
|
baseline, week 6, week 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Progress of Treatment (POT)
Time Frame: week 6, week 12
|
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.
|
week 6, week 12
|
Change in Client Satisfaction (CSQ-8)
Time Frame: week 6, week 12
|
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.
|
week 6, week 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Laura Mufson, Ph.D., Columbia University/NYSPI
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 8, 2021
Primary Completion (Actual)
July 12, 2022
Study Completion (Actual)
July 12, 2022
Study Registration Dates
First Submitted
June 9, 2021
First Submitted That Met QC Criteria
June 9, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
July 28, 2022
Last Update Submitted That Met QC Criteria
July 25, 2022
Last Verified
July 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8143
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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