Trial Outcomes & Findings for Technology Enhanced Family Treatment (NCT NCT03913013)

Last Updated: 2024-05-28

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

65 participants

Primary outcome timeframe

27 weeks (average rating across this time period)

Results posted on

2024-05-28

Participant Flow

The participant enrollment numbers reflect youth participants enrolled.

Participant milestones

Participant milestones
Measure	FFT With MCC App (FFT-MCC) 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Overall Study STARTED	32	33
Overall Study COMPLETED	29	30
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Technology Enhanced Family Treatment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	FFT With MCC App (FFT-MCC) n=32 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=33 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	Total n=65 Participants Total of all reporting groups
Age, Continuous Age, Mean yrs (SD)	15.6 years STANDARD_DEVIATION 1.7 • n=5 Participants	15.9 years STANDARD_DEVIATION 1.5 • n=7 Participants	15.8 years STANDARD_DEVIATION 1.6 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants	23 Participants n=7 Participants	47 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	10 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	6 Participants n=5 Participants	12 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	26 Participants n=5 Participants	21 Participants n=7 Participants	47 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	23 Participants n=5 Participants	23 Participants n=7 Participants	46 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	5 Participants n=7 Participants	12 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Diagnosis Depressive spectrum disorder	26 Participants n=5 Participants	27 Participants n=7 Participants	53 Participants n=5 Participants
Diagnosis Bipolar spectrum disorder	6 Participants n=5 Participants	6 Participants n=7 Participants	12 Participants n=5 Participants

PRIMARY outcome

Timeframe: 27 weeks (average rating across this time period)

Outcome measures

Outcome measures
Measure	FFT With MCC App (FFT-MCC) n=29 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=28 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation	3.39 score on a scale Standard Deviation 1.15	3.09 score on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: Outcomes scores at 27 weeks

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.

Outcome measures

Outcome measures
Measure	FFT With MCC App (FFT-MCC) n=28 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=28 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)	38.43 score on a scale Standard Deviation 14.12	33.79 score on a scale Standard Deviation 11.9

SECONDARY outcome

Timeframe: Count of participants with primary parent rated high in expressed emotion at 27 weeks.

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.

Outcome measures

Outcome measures
Measure	FFT With MCC App (FFT-MCC) n=29 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=27 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Expressed Emotion in Parents From the Five Minute Speech Sample	17 Participants	16 Participants

SECONDARY outcome

Timeframe: weekly call-ins, with linguistic counts of negative or positive words tabulated each week for 27 weeks.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Means are reported at 27 weeks (study endpoint)

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.

Outcome measures

Outcome measures
Measure	FFT With MCC App (FFT-MCC) n=32 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=33 Participants 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Children's Global Assessment of Functioning	65.97 score on a scale Standard Error 2.51	62.16 score on a scale Standard Error 2.51

Adverse Events

FFT With MCC App (FFT-MCC)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 0 deaths

FFT With App Assessments Only (FFT-Assess)

Serious events: 3 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	FFT With MCC App (FFT-MCC) n=32 participants at risk 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=33 participants at risk 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Psychiatric disorders Inpatient hospitalization or Emergency Room visit	15.6% 5/32 • Number of events 5 • 6 months Adverse events were recorded by the treating clinician and the independent evaluator at baseline, 9, 18, and 27 weeks. An Adverse Events recording form was used.	9.1% 3/33 • Number of events 3 • 6 months Adverse events were recorded by the treating clinician and the independent evaluator at baseline, 9, 18, and 27 weeks. An Adverse Events recording form was used.

Other adverse events

Other adverse events
Measure	FFT With MCC App (FFT-MCC) n=32 participants at risk 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.	FFT With App Assessments Only (FFT-Assess) n=33 participants at risk 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. Family-Focused Treatment with MCC App: 12 sessions of family-focused therapy plus use of a mobile app that enhances the skill training taught in the sessions.
Psychiatric disorders Self-harm, with or without suicidal ideation	21.9% 7/32 • Number of events 9 • 6 months Adverse events were recorded by the treating clinician and the independent evaluator at baseline, 9, 18, and 27 weeks. An Adverse Events recording form was used.	27.3% 9/33 • Number of events 9 • 6 months Adverse events were recorded by the treating clinician and the independent evaluator at baseline, 9, 18, and 27 weeks. An Adverse Events recording form was used.

Additional Information

David J. Miklowitz, Ph.D., Principal Investigator

UCLA Semel Institute for Neuroscience and Behavior

Phone: (310) 267-2659

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place