Self-Injurious BehaviorTECNCT05796531
Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization
A study testing Therapeutic Evaluative Conditioning and Neutral comparison condition in people with Self-Injurious Behavior and Suicidal Ideation, run by Franciscan Hospital For Children, INC. at 1 site in United States.
Trial summary
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among… Read more about this study
- Who is it for?
- Ages 12 to 19 years
- Conditions the study is for
- Self-Injurious Behavior, Suicidal Ideation, Suicide Attempts
- What is being tested?
- Therapeutic Evaluative Conditioning and Neutral comparison condition
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Mar 2023to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Be a patient on McLean-Franciscan Child and Adolescent Inpatient Program (MF-CAIP) of Franciscan Children's (FC)
- Be 12-19 years-old
- Own a smartphone
- Have a parent/guardian that can provide permission
- Child can assent
- Presentation to the hospital with non-suicidal self-injury (NSSI), suicidal ideation or a suicide attempt.
Who cannot join
- Any factor that impairs an individual's ability to comprehend and effectively participate in the study, including
- an inability to speak or write English fluently
- the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, etc., or the presence of extremely agitated or violent behavior
- a potential discharge location anticipated to be a residential program in which the average length of stay is more than 14 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Franciscan Hospital For Children, Inc.
Brighton, Massachusetts, 02135
Jane O'Brien, M.D., 617-779-5811, JOBrien@franciscanchildrens.org
Ralph Buonopane, Ph.D., 617-779-1689, RBuonopane@franciscanchildrens.org
About this study
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.
Read the detailed description
The project has two phases: a pilot phase and randomized controlled trial phase. The study within each phase consists of three parts: an inpatient study period, where baseline data are collected, the intervention is initiated, and treatment targets and outcomes are assessed; a one-month post-discharge period, where the intervention is continued and treatment targets and outcomes are assessed and a one-month post-intervention period, where the intervention is no longer administered but treatment targets and outcomes are assessed to test whether the intervention has sustained treatment effects. For the inpatient period, the intervention and the assessment of the treatment targets and outcomes will each be delivered via an iPad administered by a research assistant (RA). During the post-discharge and post-intervention periods assessments will be administered via smartphone mobile apps.
- Inpatient period. There are eight components to the inpatient part of the study: (1) Parent informed consent and permission. As close as possible to the patient's intake, parents will provide consent and permission for their child to participate. For patients over the age of 17, the patient will be able to provide consent for themselves. For all participants, the investigators will obtain parent consent to collect the qualitative data from the parent on their child's experience of the intervention. (2) Patient assent and baseline data collection. As part of standard clinical intake on the McLean-Franciscan inpatient unit, participants will complete a self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), which will be integrated into the study data set. As soon as possible following parental consent, study staff will meet with participant to obtain assent and collect baseline data. Patient baseline data collection will consist of administration of study measures, including explicit and implicit measures of aversion toward SITB-related and self-related stimuli (i.e., baseline assessments of the treatment target), SITB since admission will be assessed (assuming it is more than 1 day after completing the full SITBI) using a "since last assessment" version of the SITBI, and a brief interview to gather information that can will be used to personalize the TEC intervention, such as details regarding methods the patient has thought of or used to self-injure. Researchers will also schedule a time for patients to complete TEC each day of their inpatient stay. (3) Personalize TEC. Following, the interview, for participants' in the active TEC arm, researchers will setup TEC to be personalized for each participant. For example, the investigators will enter the participants' name in the positive-self TEC intervention based on studies showing that evaluative conditioning paradigms where first names are paired with positive stimuli have been shown to improve implicit affect to self-related stimuli. (4) Installation of apps on patient's phone for the post-discharge part of the study. Parents bring the patient's smartphone to the hospital. The investigators have developed procedures to facilitate receiving and returning patients' phones, such as texting parents reminders and having lockboxes available for phone drop-off and pickup. An app will be installed on participants' phone. (5) TEC intervention and pre/post ratings relevant to acceptability. Because electronic devices, such as phones or tablets, are not allowed on the inpatient unit, each day a RA will bring an iPad to the patient to complete (a) the TEC intervention and (b) pre-/post-intervention measurements of mood, desire to die and urge to kill oneself to help evaluate the acceptability of TEC. (6) Assessment of treatment target and burdensomeness of the intervention. Every three days on the inpatient unit, participants will also complete measures of explicit and implicit aversion to SITB- and self-related stimuli, which are the treatment targets and ratings of the burdensomeness of TEC to evaluate the feasibility of TEC. (7) Assessment of the outcome. Daily, prior to completing the TEC intervention, participants will complete a questionnaire regarding the occurrence of any SITB in the prior 24 hours. SITBs are assessed frequently for the purposes of accurate measurement, such that participants do not have to be remember SITB events over a few days. Daily sessions will take less than 10 minutes. (8) Qualitative interview of intervention experiences. Every three days, a brief interview will assess participants' experiences and reactions to the intervention and qualitatively assess their mood and suicidal thoughts.
- Post-discharge intervention period. For 28 days after discharge, participants will receive daily push notifications to complete a brief survey regarding SITB in the past 24 hours, the TEC intervention, and pre-/post-intervention mood, desire to die and urge to kill oneself. The push notification will be sent in the morning; additional reminders will be sent throughout the day until the tasks are completed with a maximum of 5 reminders. Once every two weeks, participants will also be asked to complete (1) implicit cognition measures to assess the treatment target and (2) a brief measure regarding the burdensomeness of TEC. A RA will contact the participant after two consecutive days of non-compliance.
- Post-intervention follow-up. Two- and four-weeks after TEC has ended, the investigators will assess implicit cognitions (i.e., the treatment target) and SITB to test whether treatment effects persist without the intervention. The investigators will send reminders and contact participants if they do not complete the assessments.
- Conditions
- Self-Injurious Behavior, Suicidal Ideation, Suicide Attempts
- Being tested
- Therapeutic Evaluative Conditioning, Neutral comparison condition
- Medical subject headings
- Self-Injurious Behavior, Suicidal Ideation, Suicide, Attempted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Evaluative ConditioningBehavioural
Participants are told which pictures are "matched pairs." They find the "matched pairs" among 4 or 8 pictures. By associating pictures and words associated with SITB (e.g., pictures of cut skin, pictures of people engaging in potentially suicidal behaviors, and the word "death") with naturally aversive images (e.g., snakes and spiders), it increases the aversion to SITB. The second goal is to increase liking toward the self by pairing self-relevant stimuli (e.g., the participant's name or other self-relevant details, as well as words like "I" and "me").
Neutral comparison conditionBehavioural
Match neutral pictures to account for doing an intervention.
| Study group | Role | What they receive |
|---|---|---|
| Active intervention arm | Active comparator | Participants will complete the intervention on a mobile device. Receives: Behavioral: Therapeutic Evaluative Conditioning |
| Control arm | Sham comparator | Participants will complete the sham comparator on a mobile device. Receives: Behavioral: Neutral comparison condition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-injurious thoughts and behaviors
The investigators will assess the presence and frequency of non-suicidal self-injury, suicidal thoughts, suicide plans, suicide attempts and other suicidal behaviors, such as aborted suicide attempts. The investigators will also assess the severity of suicidal thoughts as well.
Measured: During inpatient hospitalization (average 14 days), plus an additional two months post- hospitalization.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2023
- Study start31 Mar 2023
- Primary completion15 Aug 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Self-Injurious BehaviorStudies 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
- Intervention and control arms
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 155 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Franciscan Hospital For Children, INC.
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard University
- Responsible party
- Principal investigator, Kelly Zuromski, Franciscan Hospital For Children, INC.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05796531
- Sponsor's protocol ID
- 1R34MH124973-01
- Acronym
- TEC
- Status last verified
- Jul 2024
- First submitted
- 6 Feb 2023
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In accordance with the guidelines of this funding opportunity announcement (FOA), all data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) and the National Institute of Mental Health Data Archive (NDA). Raw (descriptive) data. The investigators will share all baseline data, summaries from behavioral tasks (i.e., Affect Misattribution Procedure) and intervention (Therapeutic Evaluative Conditioning), follow-up data, and real-time monitoring data. These data will be linked by Globally Unique Identifier (GUID) and stored in comma separated variable (CSV) format. A formal "data expected list" will be created within six months of award, as required by the FOA.
Publications
Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.
PubMed 27018530
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Evaluative Conditioning to Reduce Adolescents' Self-injurious Thoughts and Behaviors During and After Psychiatric Inpatient Hospitalization
- ClinicalTrials.gov ID
- NCT05796531
- Acronym / sponsor ID
- TEC / 1R34MH124973-01
- Conditions
- Self-Injurious Behavior, Suicidal Ideation, Suicide Attempts
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 155 participants (estimated)
- Lead sponsor
- Franciscan Hospital For Children, INC.University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Harvard University
- Study start
- 31 Mar 2023 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 3 Apr 2023 (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.
Suicide is the 2nd leading cause of death among adolescents, with the highest risk period for suicide being the month following psychiatric inpatient hospitalization. The investigators propose testing a brief, scalable intervention using evaluative conditioning aimed at reducing suicidal thoughts and behaviors among adolescents during and after inpatient hospitalization. Scalable interventions, such as the one proposed that reduce suicide risk during this markedly high-risk period, could result in large-scale decreases in suicide death.
Detailed description
The project has two phases: a pilot phase and randomized controlled trial phase. The study within each phase consists of three parts: an inpatient study period, where baseline data are collected, the intervention is initiated, and treatment targets and outcomes are assessed; a one-month post-discharge period, where the intervention is continued and treatment targets and outcomes are assessed and a one-month post-intervention period, where the intervention is no longer administered but treatment targets and outcomes are assessed to test whether the intervention has sustained treatment effects. For the inpatient period, the intervention and the assessment of the treatment targets and outcomes will each be delivered via an iPad administered by a research assistant (RA). During the post-discharge and post-intervention periods assessments will be administered via smartphone mobile apps.
- Inpatient period. There are eight components to the inpatient part of the study: (1) Parent informed consent and permission. As close as possible to the patient's intake, parents will provide consent and permission for their child to participate. For patients over the age of 17, the patient will be able to provide consent for themselves. For all participants, the investigators will obtain parent consent to collect the qualitative data from the parent on their child's experience of the intervention. (2) Patient assent and baseline data collection. As part of standard clinical intake on the McLean-Franciscan inpatient unit, participants will complete a self-report version of the Self-Injurious Thoughts and Behaviors Interview (SITBI), which will be integrated into the study data set. As soon as possible following parental consent, study staff will meet with participant to obtain assent and collect baseline data. Patient baseline data collection will consist of administration of study measures, including explicit and implicit measures of aversion toward SITB-related and self-related stimuli (i.e., baseline assessments of the treatment target), SITB since admission will be assessed (assuming it is more than 1 day after completing the full SITBI) using a "since last assessment" version of the SITBI, and a brief interview to gather information that can will be used to personalize the TEC intervention, such as details regarding methods the patient has thought of or used to self-injure. Researchers will also schedule a time for patients to complete TEC each day of their inpatient stay. (3) Personalize TEC. Following, the interview, for participants' in the active TEC arm, researchers will setup TEC to be personalized for each participant. For example, the investigators will enter the participants' name in the positive-self TEC intervention based on studies showing that evaluative conditioning paradigms where first names are paired with positive stimuli have been shown to improve implicit affect to self-related stimuli. (4) Installation of apps on patient's phone for the post-discharge part of the study. Parents bring the patient's smartphone to the hospital. The investigators have developed procedures to facilitate receiving and returning patients' phones, such as texting parents reminders and having lockboxes available for phone drop-off and pickup. An app will be installed on participants' phone. (5) TEC intervention and pre/post ratings relevant to acceptability. Because electronic devices, such as phones or tablets, are not allowed on the inpatient unit, each day a RA will bring an iPad to the patient to complete (a) the TEC intervention and (b) pre-/post-intervention measurements of mood, desire to die and urge to kill oneself to help evaluate the acceptability of TEC. (6) Assessment of treatment target and burdensomeness of the intervention. Every three days on the inpatient unit, participants will also complete measures of explicit and implicit aversion to SITB- and self-related stimuli, which are the treatment targets and ratings of the burdensomeness of TEC to evaluate the feasibility of TEC. (7) Assessment of the outcome. Daily, prior to completing the TEC intervention, participants will complete a questionnaire regarding the occurrence of any SITB in the prior 24 hours. SITBs are assessed frequently for the purposes of accurate measurement, such that participants do not have to be remember SITB events over a few days. Daily sessions will take less than 10 minutes. (8) Qualitative interview of intervention experiences. Every three days, a brief interview will assess participants' experiences and reactions to the intervention and qualitatively assess their mood and suicidal thoughts.
- Post-discharge intervention period. For 28 days after discharge, participants will receive daily push notifications to complete a brief survey regarding SITB in the past 24 hours, the TEC intervention, and pre-/post-intervention mood, desire to die and urge to kill oneself. The push notification will be sent in the morning; additional reminders will be sent throughout the day until the tasks are completed with a maximum of 5 reminders. Once every two weeks, participants will also be asked to complete (1) implicit cognition measures to assess the treatment target and (2) a brief measure regarding the burdensomeness of TEC. A RA will contact the participant after two consecutive days of non-compliance.
- Post-intervention follow-up. Two- and four-weeks after TEC has ended, the investigators will assess implicit cognitions (i.e., the treatment target) and SITB to test whether treatment effects persist without the intervention. The investigators will send reminders and contact participants if they do not complete the assessments.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Intervention and control arms
| Arm | Type | Receives |
|---|---|---|
| Active intervention arm | Active comparator | Behavioral: Therapeutic Evaluative ConditioningParticipants will complete the intervention on a mobile device. |
| Control arm | Sham comparator | Behavioral: Neutral comparison conditionParticipants will complete the sham comparator on a mobile device. |
Who may qualify
- Ages
- 12 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Be a patient on McLean-Franciscan Child and Adolescent Inpatient Program (MF-CAIP) of Franciscan Children's (FC)
- Be 12-19 years-old
- Own a smartphone
- Have a parent/guardian that can provide permission
- Child can assent
Key exclusion criteria (4 listed)
- Any factor that impairs an individual's ability to comprehend and effectively participate in the study, including
- an inability to speak or write English fluently
- the presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, acute intoxication, etc., or the presence of extremely agitated or violent behavior
- a potential discharge location anticipated to be a residential program in which the average length of stay is more than 14 days
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 |
|---|---|---|
| Therapeutic Evaluative ConditioningParticipants are told which pictures are "matched pairs." They find the "matched pairs" among 4 or 8 pictures. By associating pictures and words associated with SITB (e.g., pictures of cut skin, pictures of people engaging in potentially suicidal behaviors, and the word "death") with naturally aversive images (e.g., snakes and spiders), it increases the aversion to SITB. The second goal is to increase liking toward the self by pairing self-relevant stimuli (e.g., the participant's name or other self-relevant details, as well as words like "I" and "me"). | Behavioural | Active intervention arm |
| Neutral comparison conditionMatch neutral pictures to account for doing an intervention. | Behavioural | Control arm |
Primary outcome
Self-injurious thoughts and behaviors
Time frame: During inpatient hospitalization (average 14 days), plus an additional two months post- hospitalization.
The investigators will assess the presence and frequency of non-suicidal self-injury, suicidal thoughts, suicide plans, suicide attempts and other suicidal behaviors, such as aborted suicide attempts. The investigators will also assess the severity of suicidal thoughts as well.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
- Background: PubMed 27018530Franklin JC, Fox KR, Franklin CR, Kleiman EM, Ribeiro JD, Jaroszewski AC, Hooley JM, Nock MK. A brief mobile app reduces nonsuicidal and suicidal self-injury: Evidence from three randomized controlled trials. J Consult Clin Psychol. 2016 Jun;84(6):544-57. doi: 10.1037/ccp0000093. Epub 2016 Mar 28.
- Individual participant dataSharing planned: Yes. In accordance with the guidelines of this funding opportunity announcement (FOA), all data will be shared via the National Database for Clinical Trials related to Mental Illness (NDCT) and the National Institute of Mental Health Data Archive (NDA). Raw (descriptive) data. The investigators will share all baseline data, summaries from behavioral tasks (i.e., Affect Misattribution Procedure) and intervention (Therapeutic Evaluative Conditioning), follow-up data, and real-time monitoring data. These data will be linked by Globally Unique Identifier (GUID) and stored in comma separated variable (CSV) format. A formal "data expected list" will be created within six months of award, as required by the FOA.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Evaluative Conditioning and Neutral comparison condition in people with Self-Injurious Behavior and Suicidal Ideation, run by Franciscan Hospital For Children, INC. 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 6 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 12 Jul 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kelly Zuromski, PhD (617-475-0595, kzuromski@franciscanchildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-injurious thoughts and behaviors (time frame: During inpatient hospitalization (average 14 days), plus an additional two months post- hospitalization.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05796531, which also lists 1 linked publication.
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 12 Jul 2024.