Mood DisordersPhase 1/2NCT03913013
Technology Enhanced Family Treatment
A Phase 1/2 study testing Family-Focused Treatment with MCC App in people with Mood Disorders and Bipolar Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial summary
The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). Read more about this study
- Who is it for?
- Ages 13 to 19 years
- Conditions the study is for
- Mood Disorders, Bipolar Disorder, Major Depression
- What is being tested?
- Family-Focused Treatment with MCC App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2018to 20 Oct 2021
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 13 to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- English speaking and has access to smart-phones, a tablet, or computer
- Age 13-19 years old
- One parent with diagnosis of bipolar disorder type I, bipolar disorder type II, or
- major depressive disorder.
- At least one parent is rated high in perceived criticism of the child.
- Child shows evidence of mood instability
- Child is not currently in individual therapy.
Who cannot join
- Over 6 on the Autism Spectrum Disorder screener
- a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition manic episode of bipolar I disorder has occurred in the past 2 weeks
- history of persistent psychotic symptoms that have not remitted when mood states remit.
- intelligence quotient below 70 from school records
- Any significant and persistent substance or alcohol abuse in the prior 3 months
- Previously received a full course (i.e., 10-12 sessions) of FFT
- Current, active sexual abuse, physical abuse, or domestic violence.
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA Child and Adolescent Mood Disorders Program, UCLA School of Medicine
Los Angeles, California, 90024-1759
About this study
Official title: Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). In adolescents with mood instability who have a parent with bipolar or major depressive disorder, clinicians in community clinics will conduct FFT sessions (consisting of psychoeducation and family skills training) supplemented by weekly MCC "real time" assessments of moods and family relationships; based on results of these assessments and the family's progress in treatment, clinicians will then push personalized informational and coaching alerts regarding the practice of communication and problem-solving skills. The investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective than FFT without coaching/informational alerts in altering treatment targets and in stabilizing youths' mood symptoms and quality of life.
Read the detailed description
The investigative group has shown in several randomized trials that family-focused therapy (FFT) for symptomatic youth at high-risk for bipolar disorder - consisting of psychoeducation and family communication and problem solving skills training - is an effective adjunct to pharmacotherapy in hastening symptomatic recovery. However, between 50%-60% of high-risk youth still have residual mood symptoms and functional impairment after 18 weeks of FFT. In prior studies, two constructs have emerged as predictors of lack of response to treatment: mood instability in the child and expressed emotion (EE) in parents (i.e., frequent critical comments or hostility). In adolescents (ages 12-18) with a parent with bipolar disorder or major depressive disorder, the investigators hypothesize that augmenting FFT with frequent and targeted interventions in the home setting through a Smartphone app (MyCoachConnect, or MCC) will (a) have a greater and more rapid impact than standard FFT on the targeted mechanisms of mood instability in adolescents and EE in parents, and (b) as a result, enhance symptom resolution and functioning in adolescents. To be eligible, adolescents must score high on parent-rated measures of mood instability, and have at least one parent who is high-EE by speech sample coding criteria. The MCC app will record weekly open speech samples from parents and children and daily and weekly mood ratings from adolescents. The app assessments will be fed back to the FFT clinician, who will use this information to "push" recommendations for mood regulation, communication, and problem-solving strategies (linked to the FFT modules) for parents and youth. In year 1, the investigators will conduct an open trial (n=25) to determine (a) the feasibility and acceptability of FFT with mobile coaching (FFT-MCC), as given by clinicians in community settings, and (b) associations between online/speech feature proxies of the targets (mood instability and EE as measured weekly by MCC) and standard measures of the targets. In years 2 and 3 the investigators will conduct a 60-case randomized clinical trial in which families are assigned to FFT with MCC skills coaching or FFT with MCC assessments only, with no skills coaching. The primary hypotheses are that FFT-MCC will be acceptable to parents, adolescents and clinicians, and more effective than FFT without MCC coaching in engaging the targets of mood instability and EE and promoting improvements in adolescents' mood symptoms and quality of life over 27 weeks. The study will facilitate the translation of a technological augmentation to an evidence-based family intervention, with the goal of increasing treatment access among families with mood disorders.
- Conditions
- Mood Disorders, Bipolar Disorder, Major Depression
- Being tested
- Family-Focused Treatment with MCC App
- Keywords
- Family Therapy
- Medical subject headings
- Mood Disorders, Bipolar Disorder, Depressive Disorder, Major
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Family-Focused Treatment with MCC AppBehavioural
12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
| Study group | Role | What they receive |
|---|---|---|
| FFT with MCC App (FFT-MCC) | Experimental | Youth in this study arm will receive 12 sessions of FFT (psychoeducation, communication skills training, and problem-solving skills training) with their parents and siblings. They and their parents will make regular mobile app ratings of mood, sleep, family functioning, stress, and perceived criticism. Children and parents will call into a voice-activated phone system and be asked to speak freely for 3-5 minutes about their health and family functioning. They will be guided through 12 lesson plans in which they practice skills such as active listening or identifying prodromal signs of episodes, paralleling what they are learning in sessions. The clinician will be able to set a weekly skill training assignment and observe the family's practice of the skill between sessions. They will adapt session content accordingly. Receives: Behavioral: Family-Focused Treatment with MCC App |
| FFT with App Assessments only (FFT-Assess) | Active comparator | Youth in this condition will receive the same 12 sessions of FFT, but the app will be limited to daily and weekly assessments of their mood, sleep, stress, and family functioning. The app will not provide the skill training offered in the FFT-MCC condition. Receives: Behavioral: Family-Focused Treatment with MCC App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of weekly depressive symptom fluctuation based on an interview with the child and parent (or parent unit). The primary outcome variable for this study is the average of the ALIFE weekly consensus ratings. For the ALIFE, an independent evaluator rates the child's level of depression each week for 27 weeks on a Psychiatric Status Rating (PSR) scale ranging from 1 (asymptomatic) to 6 (extremely symptomatic). Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder) and scores of 1-2 are considered remitted. For each of 27 weeks the evaluator provides a separate rating based on the child interview and parent interview and then calculates a weekly consensus rating per ALIFE developer guidelines.
Measured: 27 weeks (average rating across this time period)
Secondary outcomes (4)
Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)
Children's Affective Lability Scale (CALS) is a 20-item parent-report survey that measures youth difficulty with affective regulation. Each item corresponds to a particular problem in affective regulation, with responses offered on a five-point scale ranging from 0 = Never or rarely occurs to 4 = 1 or more times a day). The total possible score is a sum of item scores and ranges from 0 to 80. Lower scores indicate less affective lability. In this study, a score of 20 or higher was used to indicate high mood instability.
Measured: Outcomes scores at 27 weeks
Expressed Emotion in Parents From the Five Minute Speech Sample
Parental expressed emotion is a measure of critical comments, hostility, or emotional overinvolvement. The primary instrument in this study is the Five Minute Speech Sample, which is scored by an independent evaluator on number of criticisms, presence/absence of hostility, or over-involvement. One critical comment or a rating of present for hostility or over-involvement means the parent is rated high in expressed emotion, and low expressed emotion otherwise.
Measured: Count of participants with primary parent rated high in expressed emotion at 27 weeks.
Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.
Callers are asked to speak for 3-5 minutes about how they are doing and whether anything has gone well or whether they have had difficulties. The samples will be transcribed and coded via the Linguistic Inquiry Word Count. The goal is to measure whether mood instability and expressed emotion can be captured from weekly free speech call-ins by parents or youth.
Measured: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
Children's Global Assessment of Functioning
The Children's Global Assessment of Functioning is a 1-100 rating of level of psychosocial functioning in the past 2 weeks. Higher scores indicate better functioning.
Measured: Means are reported at 27 weeks (study endpoint)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start15 Nov 2018
- Primary completion20 Oct 2021
- Study completion20 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mood DisordersStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The investigation is comparing youth who receive family-focused treatment with the MyCoachConnect (FFT-MCC) mobile application (assessments, skill training, psychoeducation) to youth who receive FFT plus only the assessment components of the MCC app (FFT-Assess) on symptomatic outcome and family functioning over 27 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, David J. Miklowitz, Ph.D., University of California, Los Angeles
- Investigators
- Armen Arevian, MD, Principal investigator, University of California, Los AngelesDavid J Miklowitz, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913013
- Sponsor's protocol ID
- IRB#18-000906
- Other IDs
- R34MH117200
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2019
- Last updated
- 28 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The investigators will submit digital files to the NIH Freedom of Information Office Coordinator containing all raw data, variable coding information, and copies of measures. The investigators will share the data with other investigators through the National Database for Clinical Trials Related to Mental Illness.
Publications
Miklowitz DJ, Chung B. Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Fam Process. 2016 Sep;55(3):483-99. doi: 10.1111/famp.12237. Epub 2016 Jul 29.
PubMed 27471058Miklowitz DJ, Weintraub MJ, Denenny DM, Merranko JA, Hooley JM. Parental expressed emotion, family conflict, and symptom severity in adolescent offspring of parents with mood disorders. J Affect Disord. 2025 Nov 15;389:119620. doi: 10.1016/j.jad.2025.119620. Epub 2025 Jun 9.
PubMed 40494497Miklowitz DJ, Ichinose MC, Weintraub MJ, Merranko JA, Singh MK. Family Conflict, Perceived Criticism, and Aggression in Symptomatic Offspring of Parents With Mood Disorders: Results From a Clinical Trial of Family-Focused Therapy. JAACAP Open. 2024 Feb 28;3(1):73-84. doi: 10.1016/j.jaacop.2024.01.008. eCollection 2025 Mar.
PubMed 40109484Miklowitz DJ, Weintraub MJ, Ichinose MC, Denenny DM, Walshaw PD, Wilkerson CA, Frey SJ, Morgan-Fleming GM, Brown RD, Merranko JA, Arevian AC. A Randomized Clinical Trial of Technology-Enhanced Family-Focused Therapy for Youth in the Early Stages of Mood Disorders. JAACAP Open. 2023 Sep;1(2):93-104. doi: 10.1016/j.jaacop.2023.04.002. Epub 2023 Apr 26.
PubMed 38094620Miklowitz DJ, Weintraub MJ, Posta F, Walshaw PD, Frey SJ, Morgan-Fleming GM, Wilkerson CA, Denenny DM, Arevian AA. Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. J Affect Disord. 2021 Feb 15;281:438-446. doi: 10.1016/j.jad.2020.12.012. Epub 2020 Dec 8.
PubMed 33360365
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-Enhanced Family-Focused Treatment for Adolescents at High Risk for Mood Disorders
- ClinicalTrials.gov ID
- NCT03913013
- Acronym / sponsor ID
- IRB#18-000906
- Conditions
- Mood Disorders, Bipolar Disorder, Major Depression
- Keywords
- Family Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 15 Nov 2018 (actual)
- Primary completion
- 20 Oct 2021 (actual)
- Study completion
- 20 Oct 2021 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Posted 28 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators propose to enhance the scalability of family-focused therapy (FFT), a 12-session evidence-based therapy for youth at high risk for mood disorders, through augmentation with a novel mobile phone application called MyCoachConnect (MCC). In adolescents with mood instability who have a parent with bipolar or major depressive disorder, clinicians in community clinics will conduct FFT sessions (consisting of psychoeducation and family skills training) supplemented by weekly MCC "real time" assessments of moods and family relationships; based on results of these assessments and the family's progress in treatment, clinicians will then push personalized informational and coaching alerts regarding the practice of communication and problem-solving skills. The investigators hypothesize that the augmented version of FFT (FFT-MCC) will be more effective than FFT without coaching/informational alerts in altering treatment targets and in stabilizing youths' mood symptoms and quality of life.
Detailed description
The investigative group has shown in several randomized trials that family-focused therapy (FFT) for symptomatic youth at high-risk for bipolar disorder - consisting of psychoeducation and family communication and problem solving skills training - is an effective adjunct to pharmacotherapy in hastening symptomatic recovery. However, between 50%-60% of high-risk youth still have residual mood symptoms and functional impairment after 18 weeks of FFT. In prior studies, two constructs have emerged as predictors of lack of response to treatment: mood instability in the child and expressed emotion (EE) in parents (i.e., frequent critical comments or hostility). In adolescents (ages 12-18) with a parent with bipolar disorder or major depressive disorder, the investigators hypothesize that augmenting FFT with frequent and targeted interventions in the home setting through a Smartphone app (MyCoachConnect, or MCC) will (a) have a greater and more rapid impact than standard FFT on the targeted mechanisms of mood instability in adolescents and EE in parents, and (b) as a result, enhance symptom resolution and functioning in adolescents. To be eligible, adolescents must score high on parent-rated measures of mood instability, and have at least one parent who is high-EE by speech sample coding criteria. The MCC app will record weekly open speech samples from parents and children and daily and weekly mood ratings from adolescents. The app assessments will be fed back to the FFT clinician, who will use this information to "push" recommendations for mood regulation, communication, and problem-solving strategies (linked to the FFT modules) for parents and youth. In year 1, the investigators will conduct an open trial (n=25) to determine (a) the feasibility and acceptability of FFT with mobile coaching (FFT-MCC), as given by clinicians in community settings, and (b) associations between online/speech feature proxies of the targets (mood instability and EE as measured weekly by MCC) and standard measures of the targets. In years 2 and 3 the investigators will conduct a 60-case randomized clinical trial in which families are assigned to FFT with MCC skills coaching or FFT with MCC assessments only, with no skills coaching. The primary hypotheses are that FFT-MCC will be acceptable to parents, adolescents and clinicians, and more effective than FFT without MCC coaching in engaging the targets of mood instability and EE and promoting improvements in adolescents' mood symptoms and quality of life over 27 weeks. The study will facilitate the translation of a technological augmentation to an evidence-based family intervention, with the goal of increasing treatment access among families with mood disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigation is comparing youth who receive family-focused treatment with the MyCoachConnect (FFT-MCC) mobile application (assessments, skill training, psychoeducation) to youth who receive FFT plus only the assessment components of the MCC app (FFT-Assess) on symptomatic outcome and family functioning over 27 weeks.
| Arm | Type | Receives |
|---|---|---|
| FFT with MCC App (FFT-MCC) | Experimental | Behavioral: Family-Focused Treatment with MCC AppYouth in this study arm will receive 12 sessions of FFT (psychoeducation, communication skills training, and problem-solving skills training) with their parents and siblings. They and their parents will make regular mobile app ratings of mood, sleep, family functioning, stress, and perceived criticism. Children and parents will call into a voice-activated phone system and be asked to speak freely for 3-5 minutes about their health and family functioning. They will be guided through 12 lesson plans in which they practice skills such as active listening or identifying prodromal signs of episodes, paralleling what they are learning in sessions. The clinician will be able to set a weekly skill training assignment and observe the family's practice of the skill between sessions. They will adapt session content accordingly. |
| FFT with App Assessments only (FFT-Assess) | Active comparator | Behavioral: Family-Focused Treatment with MCC AppYouth in this condition will receive the same 12 sessions of FFT, but the app will be limited to daily and weekly assessments of their mood, sleep, stress, and family functioning. The app will not provide the skill training offered in the FFT-MCC condition. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- English speaking and has access to smart-phones, a tablet, or computer
- Age 13-19 years old
- One parent with diagnosis of bipolar disorder type I, bipolar disorder type II, or
- major depressive disorder.
- At least one parent is rated high in perceived criticism of the child.
Key exclusion criteria (7 listed)
- Over 6 on the Autism Spectrum Disorder screener
- a Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition manic episode of bipolar I disorder has occurred in the past 2 weeks
- history of persistent psychotic symptoms that have not remitted when mood states remit.
- intelligence quotient below 70 from school records
- Any significant and persistent substance or alcohol abuse in the prior 3 months
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 |
|---|---|---|
| Family-Focused Treatment with MCC App12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions. | Behavioural | FFT with App Assessments only (FFT-Assess), FFT with MCC App (FFT-MCC) |
Primary outcome
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation
Time frame: 27 weeks (average rating across this time period)
Adolescent Longitudinal Interval Followup Evaluation (ALIFE), a measure of weekly depressive symptom fluctuation based on an interview with the child and parent (or parent unit). The primary outcome variable for this study is the average of the ALIFE weekly consensus ratings. For the ALIFE, an independent evaluator rates the child's level of depression each week for 27 weeks on a Psychiatric Status Rating (PSR) scale ranging from 1 (asymptomatic) to 6 (extremely symptomatic). Scores of 5 or higher are considered full syndromal (e.g., for major depressive disorder) and scores of 1-2 are considered remitted. For each of 27 weeks the evaluator provides a separate rating based on the child interview and parent interview and then calculates a weekly consensus rating per ALIFE developer guidelines.
4 secondary outcomes
Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)
Time frame: Outcomes scores at 27 weeks
Expressed Emotion in Parents From the Five Minute Speech Sample
Time frame: Count of participants with primary parent rated high in expressed emotion at 27 weeks.
Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.
Time frame: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.
Children's Global Assessment of Functioning
Time frame: Means are reported at 27 weeks (study endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 27471058Miklowitz DJ, Chung B. Family-Focused Therapy for Bipolar Disorder: Reflections on 30 Years of Research. Fam Process. 2016 Sep;55(3):483-99. doi: 10.1111/famp.12237. Epub 2016 Jul 29.
- Derived from this study: PubMed 40494497Miklowitz DJ, Weintraub MJ, Denenny DM, Merranko JA, Hooley JM. Parental expressed emotion, family conflict, and symptom severity in adolescent offspring of parents with mood disorders. J Affect Disord. 2025 Nov 15;389:119620. doi: 10.1016/j.jad.2025.119620. Epub 2025 Jun 9.
- Derived from this study: PubMed 40109484Miklowitz DJ, Ichinose MC, Weintraub MJ, Merranko JA, Singh MK. Family Conflict, Perceived Criticism, and Aggression in Symptomatic Offspring of Parents With Mood Disorders: Results From a Clinical Trial of Family-Focused Therapy. JAACAP Open. 2024 Feb 28;3(1):73-84. doi: 10.1016/j.jaacop.2024.01.008. eCollection 2025 Mar.
- Derived from this study: PubMed 38094620Miklowitz DJ, Weintraub MJ, Ichinose MC, Denenny DM, Walshaw PD, Wilkerson CA, Frey SJ, Morgan-Fleming GM, Brown RD, Merranko JA, Arevian AC. A Randomized Clinical Trial of Technology-Enhanced Family-Focused Therapy for Youth in the Early Stages of Mood Disorders. JAACAP Open. 2023 Sep;1(2):93-104. doi: 10.1016/j.jaacop.2023.04.002. Epub 2023 Apr 26.
- Derived from this study: PubMed 33360365Miklowitz DJ, Weintraub MJ, Posta F, Walshaw PD, Frey SJ, Morgan-Fleming GM, Wilkerson CA, Denenny DM, Arevian AA. Development and Open Trial of a Technology-Enhanced Family Intervention for Adolescents at Risk for Mood Disorders. J Affect Disord. 2021 Feb 15;281:438-446. doi: 10.1016/j.jad.2020.12.012. Epub 2020 Dec 8.
- UCLA Child and Adolescent Mood Disorders programLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. The investigators will submit digital files to the NIH Freedom of Information Office Coordinator containing all raw data, variable coding information, and copies of measures. The investigators will share the data with other investigators through the National Database for Clinical Trials Related to Mental Illness.
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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.
Armen Arevian, MD principal investigator
University of California, Los Angeles
David J Miklowitz, PhD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Family-Focused Treatment with MCC App in people with Mood Disorders and Bipolar Disorder, run by University of California, Los Angeles 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 7 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 28 May 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation (time frame: 27 weeks (average rating across this time period)). 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 NCT03913013, which also lists 5 linked publications.
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 May 2024.