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Completed

NCT Number: NCT04625686

Observational Study to Compare Outcomes of Different Psychiatric Treatment of Suicidal Adolescents

To address the unmet need of optimizing the treatment and management for adolescent suicidality, the investigators propose to evaluate the effectiveness and safety of telehealth services compared to inpatient and OCIC for suicidal adolescents in target population. To achieve this goal, the investigators propose a multi- site study to compare telehealth, OCIC, and inpatient care, and see which can lead to a lower risk of a suicidal event (primary outcome) as well as higher treatment satisfaction (TS) and satisfaction with life (SL) (secondary outcomes) of both the legal guardians/parents and patients.

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Key information

Conditions

Suicidal Ideation Behavior Behavioral Symptoms Self-Injurious Behavior Suicide

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwell Health, Queens, New York, United States

Loading trial locations.

About this study

The investigators have proposed an observational design. Eligible individuals will be identified during a crisis assessment, either in the emergency department or during an emergency phone or telehealth assessment. Once the individual has been assessed and assigned to the clinician for treatment, study staff will assess if the patient is appropriate for the study using the study eligibility criteria. Individuals who receive treatment in one of the following treatment arms will be eligible for this observation study: inpatient, in-person OCIC or telehealth crisis intervention service. Eligible individuals will be contacted by study staff to introduce and offer the study. If patient and guardian agree, they will complete surveys at baseline and every 2 weeks for 6 months to evaluate outcomes.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adolescents that are 12 through 18 years old.
  • Adolescents that are brought to the Emergency Department for crisis evaluation due to suicidal thoughts or behaviors.
  • Require a higher level of care.
  • The presence of a legal guardian for consent.
  • Capable of giving signed informed consent/assent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

Exclusion criteria

  • Adolescents with suicidal thoughts who had prior OCIC treatment in the past 12 months.
  • Adolescents without the ability to answer survey questions.
  • Adolescents that are non-English speaking due to the scales and surveys that are used for this study only being available in English.

Treatment and study plan

Mental Health Treatment

Behavioral

Treatment of suicidal ideation

Primary outcomes

  1. Number of Recurrent Suicidal Events Measured by Treatment Arm

    Time frame: 6 Months

    Compare the number of recurrent suicidal event across three treatment groups. Suicidal events were measured by hospitalizations during the study time frame in analysis.

Secondary outcomes

  1. Which Treatment Leads to Better Life Satisfaction

    Time frame: 6 Months

    The Patient-Reported Outcomes Measurement Information System (PROMIS) Pediatric Item Bank v1.0 - Short Form 4a was used to measure life satisfaction and response pattern scoring was calculated in RedCap.• Each question has five response options (1 to 5), with the total score ranging from 4 to 20, where higher values indicate better life satisfaction.

Other outcomes

  1. Treatment Satisfaction Scores Measured by Treatment Arm

    Time frame: 2 weeks

    The Client Satisfaction Questionnaire (CSQ), was used to compare the level of treatment satisfaction across three treatment groups. Data collected from children were used in outcome analysis. The four-point Likert scale, with scores from 1 to 4 for each item, provides a total score range of 8 to 32, with higher scores indicating greater satisfaction.

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • Patient-Centered Outcomes Research Institute

Registry information

Official study title

A Multi-Site, Non-Interventional Study to Compare the Outcomes of Psychiatric Treatment of Suicidal Adolescents in Different Treatment Settings

Acronym: Pre-START

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 12, 2020
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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