Technology Enhanced Family Treatment: Complete Statistical Analysis

1. Trial at a Glance

This page covers the registry results for Technology Enhanced Family Treatment (NCT03913013), a randomized phase 1, phase 2 study. The primary outcome is Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation.

2. Clinical Question

The central contrast is between two versions of treatment that both include family-focused sessions and app use. The distinction is whether the app is limited to assessments or also supplies personalized coaching and informational alerts. This matters for interpretation: the comparison is not family-focused treatment versus no treatment, nor app use versus no app use. It concerns the added features in FFT-MCC within the treatment approach described in the registry record.

3. Trial Design

The registry record describes a randomized, parallel-group, single-masked phase 1 and phase 2 study. Enrollment is listed as 65, and the study status is completed. The recorded study start is 2018-11-15, with primary completion on 2021-10-20. The sponsor is the University of California, Los Angeles. Further details about who was masked, how randomization was conducted, or how the allocation sequence was protected are not reported in the registry record.

Participants were assigned to FFT-MCC or FFT-Assess. Both arms were described as receiving 12 family-focused treatment sessions. FFT-MCC added MyCoachConnect app assessments and personalized coaching or informational alerts. FFT-Assess used app assessments without those alerts. The registry’s brief description says that clinicians were to use assessment results and family progress to guide alerts in FFT-MCC. Details such as treatment fidelity procedures, clinician training, adherence thresholds, or the exact alert schedule are not reported in the registry record.

The primary outcome is a continuous score: the average of weekly consensus depression symptom ratings over 27 weeks. The posted arm summaries include 29 participants for FFT-MCC and 28 for FFT-Assess. These outcome-specific counts need not match total enrollment, and the registry record does not explain the difference. Counts also vary among posted secondary outcomes. The criteria used to include participants in each outcome analysis, and the handling of missing assessments, are not reported in the registry record.

Although the record identifies randomization and a parallel design, the trial’s original sample-size justification, planned analysis model, prespecified covariate adjustment, and interim-analysis procedures are not reported in the registry record. The planning figures associated with the posted effects are illustrative calculations and do not describe the trial’s original design.

4. Participant Flow and Accounting

The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.

Before assignment: The participant enrollment numbers reflect youth participants enrolled.

Overall Study

5. Baseline Characteristics

The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.

6. Primary Endpoint

The registry lists the primary outcome as Average Depression Symptom Scores Over 27 Weeks on the Adolescent Longitudinal Interval Follow-up Evaluation, measured over 27 weeks (average rating across this time period).

The primary endpoint is the average depression symptom score across 27 weeks, measured with the Adolescent Longitudinal Interval Follow-up Evaluation, or ALIFE. An independent evaluator rates depressive symptoms weekly using information from interviews with the adolescent and a parent or parent unit. The weekly ratings are combined into a consensus score according to the ALIFE developer guidelines, and the primary outcome is the average of those weekly consensus ratings.

The underlying Psychiatric Status Rating scale runs from 1, described as asymptomatic, to 6, described as extremely symptomatic. Scores of 5 or higher are considered full syndromal, while scores of 1–2 are considered remitted. The endpoint therefore summarizes symptom severity over time rather than describing only one assessment at the study endpoint. A time-averaged score can reflect the course across the observation period, but it also compresses week-to-week variation into one measure.

In general, a continuous average can be useful for comparing overall symptom burden across randomized groups. It does not, by itself, show how many participants met a diagnostic threshold, whether symptoms changed at a particular week, or how individual participants’ symptoms fluctuated. The registry record does not report a threshold defining a clinically important difference in the average score.

7. Results Posted in the Registry

• FFT With App Assessments Only (FFT-Assess): mean 3.09 versus 3.39 on control; difference -0.30 (95% CI -0.84 to 0.24), standardized effect d = -0.29; z-test p = 0.274.

8. Secondary Efficacy Endpoints

The registry also posts results for secondary outcomes. For each outcome below, the endpoint type, the test applied to the posted summary statistics, the result and its interpretation are given in turn. Secondary endpoints are usually not adjusted for multiple testing, so they support rather than confirm the primary finding.

Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard deviations.
• Result:
  • FFT With App Assessments Only (FFT-Assess): mean 33.79 versus 38.43 on control; difference -4.64 (95% CI -11.48 to 2.20), standardized effect d = -0.36; z-test p = 0.184.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FFT With App Assessments Only (FFT-Assess) and the control. The interval gives the range of effects that remain compatible with the data.

Expressed Emotion in Parents From the Five Minute Speech Sample

• Endpoint type: Binary: the number of participants with the event, compared as proportions.
• Test: Unadjusted two-proportion z-test, with a Wald 95% confidence interval for the risk difference.
• Result:
  • FFT With App Assessments Only (FFT-Assess): 59.3% (16/27) versus 58.6% (17/29) on control; risk difference 0.6 percentage points (95% CI -25.1 to 26.4), risk ratio 1.01 (0.65–1.57); unadjusted two-proportion z-test p = 0.961.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FFT With App Assessments Only (FFT-Assess) and the control. The interval gives the range of effects that remain compatible with the data.

Children's Global Assessment of Functioning

• Endpoint type: Continuous: a mean value per participant, compared as a difference in means.
• Test: Unadjusted two-sample z-test for the difference in means, using the posted standard errors.
• Result:
  • FFT With App Assessments Only (FFT-Assess): mean 62.16 versus 65.97 on control; difference -3.81 (95% CI -10.77 to 3.15), standardized effect d = -0.27; z-test p = 0.283.
• Interpretation:
  • The 95% confidence interval includes no difference, so these data do not show a statistically significant difference between FFT With App Assessments Only (FFT-Assess) and the control. The interval gives the range of effects that remain compatible with the data.

The posted secondary outcomes cover mood instability, parental expressed emotion, and global functioning. The registry also lists free-speech samples coded with the Linguistic Inquiry Word Count system as a secondary outcome, but numerical results for that measure are not reported in the registry record. Across the outcomes with numerical comparisons, the estimates are uncertain, and their confidence intervals include the null value. The results do not form a clear, consistent pattern that independently resolves the uncertainty in the primary comparison.

These outcomes relate to different aspects of the treatment hypothesis. Mood instability and depression symptoms concern emotional symptoms; expressed emotion concerns a family interaction measure; global functioning addresses broader functioning. A coherent pattern across such measures could add context to the primary endpoint, but these measures are not interchangeable. Differences in construct, measurement, assessment time, and analysis population mean that a secondary result cannot simply confirm or overturn the primary result.

In general, secondary endpoints are often interpreted more cautiously when multiple outcomes are tested. Each additional comparison creates another opportunity for a chance finding. The posted secondary p-values are unadjusted, and no multiplicity procedure is reported in the registry record. Accordingly, individual secondary comparisons carry less evidential weight than a result supported by a prespecified analysis that accounts for the family of outcomes.

The registry lists several secondary outcomes, but does not report analysis details for them. It is therefore not possible to determine whether all planned secondary measures were analyzed, whether any outcomes were selected for reporting, or whether the results follow a prespecified hierarchy. The absence of reported analysis details does not establish that analyses were not conducted; it means that their methods and status are not reported in the registry record.

Taken together, the secondary results offer descriptive context rather than a definitive account of added app coaching. They neither provide strong independent confirmation of a benefit nor establish the absence of meaningful differences. Interpretation should account for uncertainty, multiple comparisons, and the incomplete reporting of the analysis plan.

Secondary outcomes registered for this trial, for reference (only those above were recalculated):

• Mood Instability, as Rated by Parents and Children Using the Children's Affective Lability Scale (CALS)
• Expressed Emotion in Parents From the Five Minute Speech Sample
• Free Speech Samples Coded Using the Linguistic Inquiry Word Count System.
• Children's Global Assessment of Functioning

9. Statistical Interpretation

10. Statistical Methods Explained

The primary outcome is continuous, so the posted comparison is expressed as a difference between arm means. A mean summarizes the average score in a group, while the standard deviation describes the spread of individual scores around that group’s mean. The primary arm summaries are 3.39 with a standard deviation of 1.15 for FFT-MCC and 3.09 with a standard deviation of 0.91 for FFT-Assess. The comparison is oriented as FFT-Assess relative to FFT-MCC, so its negative point estimate corresponds to the lower mean in FFT-Assess.

In general, a mean difference retains the original measurement scale. That can make it easier to relate the estimate to the outcome itself than a standardized effect measure. Its interpretation depends on the scale’s meaning and on what size of change is important. The registry record describes the ALIFE scale and weekly averaging, but does not report a threshold for a clinically important difference in the averaged score.

The posted p-value for the primary comparison is unadjusted. In general, a p-value is calculated under a specified statistical model and quantifies how unusual data at least as incompatible with the null model would be if that model were correct. It is not a measure of effect size, and a value above a conventional threshold does not demonstrate equivalence. The registry record does not report the sponsor’s full statistical model, adjustment set, or a prespecified decision threshold for this result.

A confidence interval describes a range of estimates compatible with the data and statistical assumptions at the stated confidence level. The posted primary interval extends across zero. This means that the data are compatible with a negative mean difference as well as a positive one. It is not a range that guarantees the true effect lies inside it, and its coverage interpretation depends on the method and assumptions used. The exact confidence level and full analysis procedure are not reported in the registry record.

For continuous outcomes, the reported standard errors describe the estimated precision of each arm’s mean. In general, standard errors tend to decrease with more observations and less variability, all else equal. The primary outcome counts are 29 and 28, and the group standard deviations are 1.15 and 0.91. The registry record does not explain the outcome-specific analysis populations or whether every participant contributed the same number of weekly ratings.

In general, over-dispersion means that observed variability is greater than a model expects. When a model does not account for that extra variability, standard errors may be too small and confidence intervals too narrow. The posted primary outcome is summarized as a continuous measure with standard deviations; the registry record does not state that an over-dispersion model was used or identify a model diagnostic. Therefore, over-dispersion should be understood as a general statistical consideration, not as a documented feature of this trial’s analysis.

Standardized effects express a mean difference relative to a measure of variability. They can help compare effects measured on different scales, but they are less directly interpretable in the outcome’s original units. The recalculated standardized effect for the primary contrast is -0.289 in the posted calculation; because it has more than three decimal places, it is not repeated. In general, a standardized effect is sensitive to the variability used in its denominator and does not substitute for a clear interpretation on the original scale.

The registry record identifies the study as randomized, single-masked, and parallel-group. Randomization is intended to make treatment groups comparable on average at assignment, while masking may reduce some forms of expectation or assessment bias. The record does not specify who was masked, how masking was maintained, whether it was assessed, or the randomization procedures. These missing details limit evaluation of how the design features were implemented.

No reported analysis details are listed for the secondary outcomes. For the primary result, the registry posts group summaries and an unadjusted comparison, but the original prespecified analysis plan, missing-data strategy, model diagnostics, and any covariate adjustment are not reported in the registry record. These omissions mean that the summary statistics can be described, but the analysis cannot be fully reproduced or checked against a stated plan.

11. Confidence Intervals and Precision

The primary mean difference is -0.3, with a confidence interval that extends from a negative value to a positive value. Because zero lies within the interval, the posted data are compatible with no average difference as well as with differences in either direction. The interval is therefore important context for the point estimate: the observed estimate is not precise enough to determine the direction of the underlying difference with confidence.

In general, a confidence interval conveys both the estimated effect and its uncertainty under a statistical method. A narrower interval indicates greater precision, while a wider interval indicates that a broader range of effects remains compatible with the data. Interval width depends on the amount of information, the variability of the measurements, and the analysis method. The registry record does not report the exact confidence level or enough detail to reconstruct all modeling choices.

The posted primary group summaries are based on 29 participants in FFT-MCC and 28 in FFT-Assess. The study enrollment is 65, but the registry record does not explain why the primary outcome counts differ from total enrollment. Nor does it report how missing weekly ratings affected the average score or the comparison. These uncertainties matter because the precision of a treatment estimate depends not only on the nominal number enrolled but also on the usable outcome information and its variability.

The interval should not be read as evidence that all values it spans are equally plausible, or that values outside it are impossible. It is a summary of uncertainty under a particular analysis. Since the original analysis plan is not reported in the registry record, the interval is best interpreted alongside the stated arm means and unadjusted comparison, without assuming unreported adjustments or missing-data procedures.

12. Planning a Similar Trial: Sample Size

This is a planning illustration, not a re-evaluation of the original trial. It asks: if a new study wanted to detect a difference like the one observed, or a smaller one, how large would it need to be? It is deliberately not “observed power” of the finished trial, which is not a meaningful quantity.

The sample-size figures are planning illustrations based on the observed effects, not a record of the trial’s original design assumptions. For the continuous and binary outcomes posted, the figures are participants per arm, not total events. The stated planning assumptions are a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. Each scenario asks how many participants per arm would be needed to detect the stated fraction of the observed effect.

The 80% power column means the planned sample would have an 80% chance of producing a statistically significant result under the assumed effect and calculation model, if those assumptions held. The 90% power column represents a higher target chance under the same framework. Power is a property of a specified design and assumed effect, not a measure of what the completed trial achieved.

The rows for 100%, 75%, and 50% of the observed effect are alternative planning scenarios. A smaller effect is harder to distinguish from random variation, so the planning calculation requires more participants per arm to attain the same power target. The large differences among those scenarios reflect how strongly sample-size requirements depend on the effect size used for planning.

These figures are not observed power. They are illustrative calculations from the posted effects and do not reveal the investigators’ original sample-size justification. That justification, including its assumed effect, power target, and other design choices, is not reported in the registry record. The numbers should therefore be read as hypothetical planning references, not as evidence that the trial was designed to detect the posted effect or that a particular future study will have the same requirements.

13. How the Sample Size Is Derived

Power is the probability that a study of a given size rejects the null hypothesis when a specific true effect exists. It depends on four things: the effect to detect, the variability of the outcome, the significance level (here a two-sided α of 0.05, so z_1−α/2 = 1.960) and the desired power (z_1−β = 0.842 for 80% and 1.282 for 90%).

Formula

n is the number of participants in each arm, Δ is the difference in means to detect and σ is the common standard deviation.

Worked calculation for this trial

1. Observed difference Δ = -0.300; pooled standard deviation σ = 1.039.
2. n = 2 × (1.96 + 0.842)² × 1.039² / -0.300² = 188.3, rounded up to 189 participants per arm for 80% power.

The smaller-effect rows in the table above repeat the same calculation with the effect multiplied by 0.75 and 0.5 (for ratios, applied to the logarithm of the ratio).

R code

alpha <- 0.05
z_a   <- qnorm(1 - alpha / 2)          # two-sided
delta <- -0.3                      # observed difference in means
sigma <- 1.03913163047544                     # pooled standard deviation
n_per_arm <- function(power, frac = 1) {
  ceiling(round(2 * (z_a + qnorm(power))^2 * sigma^2 / (delta * frac)^2, 6))
}
for (f in c(1, 0.75, 0.5))
  cat(sprintf("%3.0f%% of observed effect: n per arm = %s (80%% power), %s (90%% power)\n", 100 * f,
              format(n_per_arm(0.80, f), big.mark = ","), format(n_per_arm(0.90, f), big.mark = ",")))

# Check against R's built-in function (t-based, so very slightly larger)
cat("power.t.test:", round(power.t.test(delta = delta, sd = sigma, power = 0.80)$n, 1), "\n")

# Simulation: exact two-sample t-test using simulated means and variances
set.seed(3913013)
n    <- n_per_arm(0.80)
reps <- 20000
m_diff <- rnorm(reps, delta, sigma * sqrt(2 / n))             # difference in sample means
s2     <- sigma^2 * rchisq(reps, 2 * (n - 1)) / (2 * (n - 1))   # pooled sample variance
tstat  <- m_diff / sqrt(s2 * 2 / n)
cat(sprintf("Simulated power at n = %s per arm: %.3f (%d replicates)\n", format(n, big.mark = ","), mean(abs(tstat) > qt(0.975, 2 * (n - 1))), reps))

Output from running the code

100% of observed effect: n per arm = 189 (80% power), 253 (90% power)
 75% of observed effect: n per arm = 335 (80% power), 449 (90% power)
 50% of observed effect: n per arm = 754 (80% power), 1,009 (90% power)
power.t.test: 189.3 
Simulated power at n = 189 per arm: 0.803 (20000 replicates)

The simulation draws many sets of group means and variances at the planned sample size and counts how often the two-sample t-test rejects the null. It should land close to the target power; at very small required sample sizes it can fall below it, because the normal approximation is rough there.

14. Multiplicity, Missing Data and Analysis Populations

Multiplicity arises when several hypotheses or outcomes are examined. Even if each analysis uses the same nominal significance threshold, the chance of at least one apparently notable result can increase as the number of analyses grows. In general, researchers may address this by prespecifying a hierarchy of outcomes, adjusting the significance threshold, or clearly labeling secondary analyses as exploratory. The registry record does not report a multiplicity adjustment or a hierarchy governing interpretation of the primary and secondary outcomes.

The record identifies one primary outcome and lists secondary outcomes, but the detailed analysis plans for the secondary measures are not reported in the registry record. It is not reported whether additional subgroup, sensitivity, or interim analyses were planned or conducted. The count of posted analyses is not a substitute for an analysis plan: without the plan, it is not possible to establish which comparisons were prespecified or how selective reporting was managed.

Missing-data methods are also important. The primary endpoint is intended to average weekly ratings over 27 weeks, but the registry record does not describe how missing weekly assessments were handled, whether participants with incomplete ratings were included, or what assumptions were used. It also does not report a sensitivity analysis assessing how different missing-data assumptions might change the result. The outcome-specific participant counts vary, and the record does not explain the reasons.

The analysis population is not specified in sufficient detail to determine whether the comparison included everyone as randomized, only participants with available endpoint data, or another set. The registry record does not report an intention-to-treat definition, a per-protocol population, or criteria for excluding observations. Those choices can affect the meaning of a randomized comparison, particularly if exclusions or incomplete data differ by arm.

In general, prespecified methods for multiplicity and missing data help readers assess how much confidence to place in a result and whether it could depend on analytic choices. Their absence from the registry record does not show that the investigators lacked such procedures; it means that they are not reported there. Consequently, the unadjusted comparisons should be treated as limited summaries rather than a complete account of confirmatory inference.

15. Safety Results

The registry reports serious adverse events as affected participants divided by participants at risk.

Deaths

Other (non-serious) adverse events

Participants with at least one non-serious event at or above the registry's 5% reporting threshold.

Most frequent serious adverse event terms

Most frequent non-serious adverse event terms

Serious events with the highest arm-level rate: inpatient hospitalization or emergency room visit (15.6%).

The serious adverse event figures are counts of participants affected and counts at risk in each arm. In FFT-MCC, 5 of 32 participants were listed as affected by a serious adverse event; in FFT-Assess, the corresponding figures were 3 of 33. The registry lists zero deaths in each arm. These are descriptive counts and should not be interpreted as a comparison adjusted for differences in follow-up or other factors.

For other adverse events, the listed counts are 7 of 32 in FFT-MCC and 9 of 33 in FFT-Assess. The registry names inpatient hospitalization or emergency room visit as the leading serious-event term and gives 15.6%. It does not provide enough detail in this record to establish the event-specific distribution by arm, severity criteria, attribution to treatment, timing, or duration.

In general, adverse-event counts are interpreted in light of definitions, observation time, and completeness of reporting. The registry record does not report those details sufficiently to support a causal safety comparison. The figures describe what was posted, not whether an intervention caused an event or whether the difference between arms is meaningful.

16. What the Result Does, and Does Not, Mean

The result does show the observed average depression symptom scores in the two arms over the specified 27-week period. The mean was 3.39 in FFT-MCC and 3.09 in FFT-Assess, and the posted mean difference was -0.3 when expressed as FFT-Assess relative to FFT-MCC. The unadjusted confidence interval spans zero, and the p-value is 0.274. Together, these summaries indicate substantial uncertainty about the direction and magnitude of the average difference.

The result does not establish that adding MyCoachConnect coaching alerts improves or worsens depression symptoms. It also does not show that the two treatment approaches are equivalent. Demonstrating equivalence or non-inferiority would require a prespecified margin and a suitable analysis; such a margin is not reported in the registry record. A result that does not clearly distinguish a difference from zero should not be recast as proof that there is no difference.

The comparison is specific to the randomized groups and treatment contrast described in this study: family-focused treatment with app coaching and alerts versus family-focused treatment with app assessments only. It does not compare either approach with no treatment, and it does not isolate the effect of family-focused treatment itself. The registry record does not report evidence about longer-term outcomes beyond the stated assessment period.

The observed score is an average across weekly ratings. It cannot show whether a subset of participants experienced a different course, whether change occurred at a particular time, or how many participants crossed a symptom threshold. The primary endpoint description identifies scale values associated with symptom states, but the posted group averages are not individual diagnoses.

Finally, the record’s missing detail about analysis populations, missing observations, and prespecified methods limits the conclusions that can be drawn from the summary comparison. The posted data are informative as an uncertain estimate, but they do not by themselves establish a causal effect, clinical importance, or generalizability to populations and settings not described in the registry record.

17. Why This Trial Matters Statistically

This trial raises a statistical question about how to evaluate an added digital component when both groups receive the same underlying family-focused treatment. The randomized contrast is informative about the incremental package of app coaching and alerts relative to app assessments only, rather than about the treatment as a whole. Making that distinction clear prevents the comparison from being interpreted as a test of app use versus no app use.

The endpoint also illustrates a common measurement choice in clinical research: averaging repeated symptom ratings over time. This can capture overall symptom burden across the observation period, while concealing fluctuations that may be important to participants or clinicians. The ALIFE consensus process combines child and parent interview information into weekly ratings, then summarizes them across 27 weeks. Both the repeated measurement and averaging strategy shape what the final score can mean.

The reported point estimate is accompanied by uncertainty that includes both directions of difference. This is a useful reminder that an estimate should not be judged by its direction alone, and that a nonsignificant p-value is not evidence of equivalence. The sample-size illustrations also show, as a general planning principle, how assumed effect size influences the number of participants needed for a chosen power target.

Finally, the record demonstrates why transparent reporting of analysis populations, missing-data handling, multiplicity plans, and model details matters. These details are needed to assess whether the available summaries answer the intended question and how robust the result is to analytic choices. Their absence limits interpretation without negating the descriptive information that is posted.

18. Limitations

• The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
• Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.

The registry record provides limited detail on the conduct of randomization and masking. It identifies a randomized, single-masked design but does not state who was masked, how the sequence was generated or concealed, or how masking was maintained. These details would help readers assess the potential for selection and assessment biases.

The outcome counts are smaller than total enrollment for the primary endpoint, and counts differ across the posted outcomes. The registry record does not explain these differences, identify the analysis population, or describe how missing weekly ratings were handled. It also does not report whether the analysis adjusted for baseline scores or other covariates, or whether sensitivity analyses were conducted.

The original sample-size justification and detailed statistical analysis plan are not reported in the registry record. The available planning calculations use observed effects and should not be mistaken for the study’s original design basis. The record also does not report an adjustment for multiple comparisons, a clinically important difference threshold, or detailed methods for secondary outcome analyses.

Some secondary outcomes are listed without numerical results in the registry record, including free-speech coding. The serious adverse event summary provides counts but limited information about definitions, timing, attribution, and event-level distribution. These reporting gaps restrict evaluation of completeness and interpretation.

These limitations concern what can be established from the registry record. They do not demonstrate that a particular method was not used or that unreported results are unfavorable; rather, the relevant information is not reported in the registry record. The completed study’s posted summaries therefore support cautious description, but not a full independent appraisal of all design and analysis decisions.

19. Related Tutorials

20. Related Statistical Calculators

21. Sources

• ClinicalTrials.gov: Technology Enhanced Family Treatment — NCT03913013.
• Registry record last updated 2024-05-28; status last verified 2024-04.
• Results first posted 2024-05-28.
• Data retrieved from ClinicalTrials.gov on 2026-11-09.
• Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.

22. Record Summary

The registry record describes a completed randomized, parallel-group, single-masked phase 1 and phase 2 study with enrollment of 65. It compared 12 sessions of family-focused treatment plus MyCoachConnect app coaching and informational alerts with the same treatment accompanied by app assessments only.

The primary outcome was the average weekly ALIFE depression symptom score across 27 weeks. The posted means were 3.39 for FFT-MCC and 3.09 for FFT-Assess; the mean difference was -0.3, with an unadjusted p-value of 0.274 and a confidence interval spanning zero. This is an uncertain comparison, not evidence of equivalence or a definitive causal effect.

Secondary outcomes and adverse-event counts provide additional descriptive information, but analysis details, missing-data methods, multiplicity procedures, and the original sample-size justification are not reported in the registry record.