Living in Families With EmotionsNCT06793878
School-Based Living In Families With Emotions Training
A study testing Living in Families With Emotions in people with Living in Families With Emotions, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
The overall purpose of this study is to identify adolescents who are at-risk for psychosis, as evidenced by endorsement of mild-to-moderate, sub-syndromal symptoms, and provide them with a potentially preventive intervention aimed at enhancing resilience. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Living in Families With Emotions
- What is being tested?
- Living in Families With Emotions
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jan 2020to 20 Jul 2024
- 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 10 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Male and female adolescents from the Boston area who are in middle school at the time of enrollment;
- Enrolled in a school where study screening is taking place;
- Have a parent or legal guardian who is able and willing to provide written informed consent;
- Competent and willing to provide written informed assent;
- English language proficiency of parent/guardian and participant;
- Response of "yes, definitely" or "maybe" to auditory hallucinations, visual hallucinations, or paranoia on the Adult Psychotic-like Symptom Checker (APSS);
- Able to safely participate in the protocol and appropriate for outpatient level of care, in the opinion of the investigator.
Who cannot join
- Current DSM-V diagnosis with serious active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization;
- Current enrollment in psychological or behavioral health treatment;
- Current use of psychotropic medications (other than stimulants) prescribed by a physician;
- Severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Charlestown, Massachusetts, 02129
About this study
The overall purpose of this study is to identify adolescents who are at-risk for psychosis, as evidenced by endorsement of mild-to-moderate, sub-syndromal symptoms, and provide them with a potentially preventive intervention aimed at enhancing resilience.
- Conditions
- Living in Families With Emotions
- Being tested
- Living in Families With Emotions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living in Families With EmotionsBehavioural
This is an 8-week group-based psychosocial intervention teaching adolescents how to recognize their feelings, manage them, and talk about emotions through group discussions, live exercises, and games. The adolescents' caregivers are also provided with the same information, through two live sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Living in Families with Emotions (LIFE) Receives: Behavioral: Living in Families With Emotions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intervention Feasibility and Acceptability
This measure includes participant (both adolescent and parent/caregiver) attendance, with more attendance of the intervention indicating better feasibility and acceptability.
Measured: Before the intervention and 8 weeks later
Adolescent Psychotic-Like Symptom Screener (APSS)
The APSS is a 7-item measure assessing the presence of: visual and auditory hallucinations, paranoia, grandiosity, delusions of control, mind reading, and delusions of reference. Items are scored on a 3-point Likert scale (0=No, never, 0.5=Maybe, or 1=Yes, definitely) and are then summed for a total score.
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Secondary outcomes (5)
The Center for Epidemiological Studies Depression scale for children (CES-DC)
The CES-DC is a 20-item self-report measure rated on a 4-point Likert scale that captures symptoms of depression within the past week, with higher ratings representing more severe depression.
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Concise Health Risk Tracking Self-Report (CHRT-SR)
The CHRT-SR measures suicidal thoughts and behaviors using 14-items, with higher ratings indicating more suicidal thoughts and behaviors.
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Screen for Child Anxiety Related Disorders (SCARED)
The SCARED is a 41 item measure to capture anxiety. It is rated on a 3 point Likert scale (not true or hardly ever true, somewhat true or sometimes true, or very true or often true).
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Child Behavior Checklist (CBCL)
Parents/caregivers rated the CBCL, a 113-item multiple choice self-report measure to capture psychiatric symptoms of the adolescent through parent/caregiver ratings.
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Penn Emotion Recognition Test (ER-40)
This is a 15-minute computer-based task which involves identifying which emotion (neutral, sad, happy, angry, or scared) is being expressed in 40 (half male and half female presenting) online images of faces to measure facial emotion recognition.
Measured: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2025
- Study start29 Jan 2020
- Primary completion18 Jan 2024
- Study completion20 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Living in Families With EmotionsStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daphne Holt, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06793878
- Sponsor's protocol ID
- 2019P003154
- Status last verified
- Jan 2025
- First submitted
- 21 Jan 2025
- Last updated
- 27 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- School-Based Living In Families With Emotions Training
- ClinicalTrials.gov ID
- NCT06793878
- Acronym / sponsor ID
- 2019P003154
- Conditions
- Living in Families With Emotions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 29 Jan 2020 (actual)
- Primary completion
- 18 Jan 2024 (actual)
- Study completion
- 20 Jul 2024 (actual)
- First posted
- 27 Jan 2025 (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.
The overall purpose of this study is to identify adolescents who are at-risk for psychosis, as evidenced by endorsement of mild-to-moderate, sub-syndromal symptoms, and provide them with a potentially preventive intervention aimed at enhancing resilience.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Behavioral: Living in Families With EmotionsLiving in Families with Emotions (LIFE) |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Male and female adolescents from the Boston area who are in middle school at the time of enrollment;
- Enrolled in a school where study screening is taking place;
- Have a parent or legal guardian who is able and willing to provide written informed consent;
- Competent and willing to provide written informed assent;
- English language proficiency of parent/guardian and participant;
Key exclusion criteria (4 listed)
- Current DSM-V diagnosis with serious active symptoms (such as active psychotic symptoms, current suicidality, serious active alcohol or substance use, marked deterioration in functioning over the prior month) that necessitates close monitoring or individual therapy and/or inpatient or partial hospitalization;
- Current enrollment in psychological or behavioral health treatment;
- Current use of psychotropic medications (other than stimulants) prescribed by a physician;
- Severe developmental delays (including, but not limited to, Autism Spectrum Disorder, Intellectual Disability, and Down Syndrome).
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 |
|---|---|---|
| Living in Families With EmotionsThis is an 8-week group-based psychosocial intervention teaching adolescents how to recognize their feelings, manage them, and talk about emotions through group discussions, live exercises, and games. The adolescents' caregivers are also provided with the same information, through two live sessions. | Behavioural | Intervention Arm |
Primary outcome
Intervention Feasibility and Acceptability
Time frame: Before the intervention and 8 weeks later
This measure includes participant (both adolescent and parent/caregiver) attendance, with more attendance of the intervention indicating better feasibility and acceptability.
Adolescent Psychotic-Like Symptom Screener (APSS)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
The APSS is a 7-item measure assessing the presence of: visual and auditory hallucinations, paranoia, grandiosity, delusions of control, mind reading, and delusions of reference. Items are scored on a 3-point Likert scale (0=No, never, 0.5=Maybe, or 1=Yes, definitely) and are then summed for a total score.
5 secondary outcomes
The Center for Epidemiological Studies Depression scale for children (CES-DC)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Concise Health Risk Tracking Self-Report (CHRT-SR)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Screen for Child Anxiety Related Disorders (SCARED)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Child Behavior Checklist (CBCL)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
The Penn Emotion Recognition Test (ER-40)
Time frame: Before the intervention, 8 weeks later, 6 months later, and 12 months later
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2025.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living in Families With Emotions in people with Living in Families With Emotions, run by Massachusetts General Hospital 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 7 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: finished, as of the sponsor's last update on 27 Jan 2025. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intervention Feasibility and Acceptability (time frame: Before the intervention and 8 weeks later). The study lists 2 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 27 Jan 2025.