Psychiatric DiagnosisNCT04931927
Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment
A study testing Making Connections Intervention-Telehealth (MCI-T) and Treatment as usual (TAU) in people with Psychiatric Diagnosis, run by New York State Psychiatric Institute at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Psychiatric Diagnosis
- What is being tested?
- Making Connections Intervention-Telehealth (MCI-T) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Nov 2021to 12 Jul 2022
- Phase
- Interventional
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
- Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC
- Clinician consent
- English or bilingual in English and Spanish
Who cannot join
- 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
- 1. None
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
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.
Read the 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.
- Conditions
- Psychiatric Diagnosis
- Being tested
- Making Connections Intervention-Telehealth (MCI-T), Treatment as usual (TAU)
- Keywords
- anxiety, depression, telehealth, behavioral problems
- Medical subject headings
- Mental Disorders, Anxiety Disorders, Depression, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Making Connections Intervention-Telehealth (MCI-T)Behavioural
Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) [MCI-T +TAU]
Treatment as usual (TAU)Behavioural
Telehealth treatment as usual without the single session telehealth engagement intervention
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Participants are randomized to treatment as usual (TAU) Receives: Behavioral: Treatment as usual (TAU) |
| MCI-T | Experimental | Participants are randomized to the Making Connections Intervention-Telehealth (MCI-T) plus treatment as usual (TAU) Receives: Behavioral: Making Connections Intervention-Telehealth (MCI-T); Behavioral: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: baseline, week 6, week 12
Secondary outcomes (2)
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.
Measured: week 6, week 12
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.
Measured: week 6, week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start8 Nov 2021
- Primary completion12 Jul 2022
- Study completion12 Jul 2022
Why it stopped: This study has been terminated due to a change in study design. The study is no longer a RCT.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychiatric DiagnosisStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Mufson, New York State Psychiatric Institute
- Investigators
- Laura Mufson, Ph.D., Principal investigator, Columbia University/NYSPI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04931927
- Sponsor's protocol ID
- 8143
- Status last verified
- Jul 2022
- First submitted
- 9 Jun 2021
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Telehealth on Engagement in Psychotherapy and/or Medication Treatment
- ClinicalTrials.gov ID
- NCT04931927
- Acronym / sponsor ID
- 8143
- Conditions
- Psychiatric Diagnosis
- Keywords
- anxiety, depression, telehealth, behavioral problems
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study has been terminated due to a change in study design. The study is no longer a RCT.
- Enrolment
- 14 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- 8 Nov 2021 (actual)
- Primary completion
- 12 Jul 2022 (actual)
- Study completion
- 12 Jul 2022 (actual)
- First posted
- 18 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Behavioral: Treatment as usual (TAU)Participants are randomized to treatment as usual (TAU) |
| MCI-T | Experimental | Behavioral: Making Connections Intervention-Telehealth (MCI-T), Behavioral: Treatment as usual (TAU)Participants are randomized to the Making Connections Intervention-Telehealth (MCI-T) plus treatment as usual (TAU) |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
- Work as a clinician in any MSCH Outpatient Behavioral Health Service or DESC
- Clinician consent
- English or bilingual in English and Spanish
Key exclusion criteria (3 listed)
- 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
- 1. None
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 |
|---|---|---|
| Making Connections Intervention-Telehealth (MCI-T)Single session telehealth engagement intervention plus telehealth treatment as usual (TAU) [MCI-T +TAU] | Behavioural | MCI-T |
| Treatment as usual (TAU)Telehealth treatment as usual without the single session telehealth engagement intervention | Behavioural | Control, MCI-T |
Primary outcome
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).
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).
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).
2 secondary outcomes
Change in Progress of Treatment (POT)
Time frame: week 6, week 12
Change in Client Satisfaction (CSQ-8)
Time frame: week 6, week 12
Results and safety
The study was stopped early (reason given: This study has been terminated due to a change in study design. The study is no longer a RCT.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Laura Mufson, Ph.D. principal investigator
Columbia University/NYSPI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Making Connections Intervention-Telehealth (MCI-T) and Treatment as usual (TAU) in people with Psychiatric Diagnosis, run by New York State Psychiatric Institute 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 5 inclusion and 3 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: stopped early, as of the sponsor's last update on 28 Jul 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 was stopped early (reason given: This study has been terminated due to a change in study design. The study is no longer a RCT.). Results are not available in the source record.
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?
Change in the Working Alliance Inventory (WAI-S) (time frame: week 1, week 6, week 12 (post intervention)). The study lists 3 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 28 Jul 2022.