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

NCT04931927 | Terminated

• 1 other identifier: 8143
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychiatric Diagnosis

Keywords

anxiety; depression; telehealth; behavioral problems

Outcome Measures

Primary Outcomes (3)

• 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).

  week 1, week 6, week 12 (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).

  baseline, week 6, week 12 (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).

  baseline, week 6, week 12

Secondary Outcomes (2)

• Change in Progress of Treatment (POT)

  week 6, week 12

• Change in Client Satisfaction (CSQ-8)

  week 6, week 12

Study Arms (2)

Control

ACTIVE COMPARATOR

Participants are randomized to treatment as usual (TAU)

Behavioral: Treatment as usual (TAU)

MCI-T

EXPERIMENTAL

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

Behavioral: Making Connections Intervention-Telehealth (MCI-T); Behavioral: Treatment as usual (TAU)

Interventions

Making Connections Intervention-Telehealth (MCI-T) BEHAVIORAL

Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) \[MCI-T +TAU\]

MCI-T

Treatment as usual (TAU) BEHAVIORAL

Telehealth treatment as usual without the single session telehealth engagement intervention

Control; MCI-T

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC
• Clinician consent
• English or bilingual in English and Spanish
• \. None

Sponsors & Collaborators

• New York State Psychiatric Institute: lead

Study Sites (1)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Mental Disorders; Anxiety Disorders; Depression; Problem Behavior

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Child Behavior

Study Officials

• Laura Mufson, Ph.D.

  Columbia University/NYSPI

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medical Psychology (in Psychiatry)

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: June 9, 2021
• First Posted: June 18, 2021
• Study Start: November 8, 2021
• Primary Completion: July 12, 2022
• Study Completion: July 12, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)