A Pilot Randomized Trial of Video-based Family Therapy for Home Visited Mothers With Perinatal Depressive Symptoms
Phase: NA
Conditions: Perinatal Depression, Postpartum Depression, Family Conflict
Sponsor: Dartmouth-Hitchcock Medical Center

 
 
Official Title: 
A Pilot Randomized Trial of Video-based Family Therapy 
for Depressed Home Visited Mothers 
NCT number: 
NCT04741776 
Document Type:  
Protocol and Statistical Analysis Plan 
Date of the 
Document: 
10/08/2020 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Study Protocol 
Study Purpose: Assess the feasibility, acceptability, tolerability, safety, and preliminary 
effectiveness of a video-based family therapy intervention (Resilience Enhancement Skills 
Training, REST) in home visited mothers (pregnant and postpartum) with moderate to severe 
depressive symptoms and moderate to high family conflict.  
Study Design: Effectiveness-implementation hybrid type 1 design with a pilot randomized trial.  
Sample Size: We aimed to enroll 80 home visited mothers and their family members (N=160) in 
the study. 
Characteristics of Subject Population: Mothers, at least 15 years old, in any trimester of 
pregnancy through 18 months postpartum, enrolled in participating home visiting (HV) agencies 
with moderate to severe depressive symptoms on the Beck Depression Inventory-Second 
Edition [BDI-II] scores of ≥ 20 and moderate to high family conflict with their family members on 
the Perceived Hostility Survey (Ages 18+) raw scores of at least 16 or Perceived Hostility 
Survey (Ages 8-17) raw scores of at least 14. Family member is defined as the mother’s adult 
relative or her current intimate partner with whom she either lives with in the same home or has 
at least weekly contact. Family is defined as a dyad that includes the mother and her family 
member.  
Scheme. The mother was the unit of randomization in the study. Block randomization with block 
size of 4 using R package “Blockrand”  was used to randomize the mothers to the study groups. 
Mothers were randomized with equal probability to one of two study groups: 1) video-based 
family therapy (Resilience Enhancement Skills Training, REST), or 2) the active comparison 
condition standard of care (Video-delivered individual Problem Solving Therapy, V-PST). The 
family received REST. Although only the mother received V-PST, the mother and her family 
member were asked to complete outcome measures. 
Process and blinding. The Statistician used Blockrand to randomize the mothers, by unique 
study IDs, to the study groups. The PI communicated with Statistician to obtain the study group 
assignments by unique study ID. The PI called the therapist and family to communicate the 
study group assignment on the same day the mother and her family member completed the 
baseline interview. The Research Assistants remained blind to study group assignment, and 
study participants (mothers and their family members) were instructed by the PI not to discuss 
their study group assignment with the Research Assistant who administered the study 
questionnaires to them. In addition, the PI instructed the Research Assistants to remind each 
study participant not to disclose the study group assignment prior to administering each study 
questionnaire. Research assistants were regularly supervised by the PI. 
Outcomes: The primary outcomes included maternal depressive symptoms (measured using 
the Beck Depression Inventory-Second Edition), family conflict (measured using the Perceived 
Hostility Survey Ages 18+ and Ages 8-17 years old), and family cohesion (measured using the 
Multidimensional Scale of Perceived Social Support – Family subscale). The secondary 
outcome included maternal job attainment/school enrollment measured using an adapted ABCD 
study item. Outcomes were assessed from baseline through post-intervention (within one week 
of the final therapy session), three months later, and six months later.  

Monitoring Trial Performance. The PI developed and utilized structured processes for ensuring 
intervention fidelity and fidelity to the study protocol. For this study, the PI 1) developed initial 
trainings and refresher trainings for data collection procedures and adherence to safety 
protocols for research staff; 2) supervised the research staff to ensure adherence to recruitment, 
data collection, and retention procedures; 3) held weekly meetings with lead staff at participating 
home visiting agencies to discuss recruitment, home visitor study responsibilities, and any 
issues related to reallocation of home visitor study responsibilities due to home visitor turnover. 
In addition, the study included data entry software that minimized missing data by flagging 
missed items before questionnaires were submitted. The secure, password protected database 
was regularly maintained and monitored throughout the study. 
Fidelity monitoring for the interventions occurred in two phases. In phase one, the PI and 
Problem Solving Therapy (PST) expert assessed fidelity on a weekly basis in all 10 audio-
recorded sessions for the first 2 families who are assigned to each REST therapist.  They 
continued to assess fidelity on a weekly basis in all 10 audio-recorded sessions for the first two 
mothers who were assigned to each V-PST therapist. The PI and PST expert discussed and 
resolved any discrepancies in these fidelity assessments. The PI immediately provided any 
corrective feedback to REST therapists in weekly supervision.  For the V-PST therapists, the PI 
immediately communicated any corrective feedback to the V-PST supervisor to address with the 
therapists in weekly supervision.  
In phase two, the PST expert assessed fidelity in 10% of randomly selected audio-
recorded REST sessions, originally assessed by the PI, and 10% of randomly selected audio-
recorded V-PST sessions, originally assessed by the PI. The PST expert and the PI discussed 
and resolved any discrepancies in the fidelity assessments throughout Years 1 and 2 of the 
proposed study. These fidelity assessments occurred on an ongoing basis in order to provide 
immediate corrective feedback to REST therapists and V-PST therapists to ensure high fidelity. 
Data and Safety Monitoring Board Procedures (DSMB). The DSMB has established 
procedures of operation and guidelines for determining the methods and frequency for review of 
Departmental studies. Table 1, below, guides the risk assessment for the study. Based on the 
DSMB’s established guidelines, the study’s total score of 6 on the 10-point scoring system 
indicates that it poses greater than minimal risk to human subjects. Tasks related to participant 
safety included the PI’s assessment of potential risks associated with study recruitment and 
participation, and the design and implementation of procedures to minimize these risks should 
they arise. According to the Departmental DSMB policy, studies in this risk category will be 
independently monitored by a group of knowledgeable faculty members and an independent 
statistician. The DSMB met twice per year to monitor the study, which included data analysis by 
the independent statistician. 
 
Table 1. Study Risk Assessment * 
ENTE
R 
SCOR
E  
I. Experimental Treatment  
Low Risk  
No experimental treatment in 
study  
1 point  
 
 
Moderate Risk  
 
Treatment effects documented 
from studies with similar and/or 
2 points  
 
 
2 

different populations and/or 
settings. No serious adverse 
events expected. Specific plans 
to monitor adverse events 
(AE’s) detailed in DSM plan.  
High Risk  
 
Experimental treatment is being 
regulated by the FDA (e.g., 
investigational drug, device, or 
biologic)  
4 points  
 
 
 
II. Procedures, Measurement, and Data Collection Methods  
Low Risk  
 
Minimally invasive with low 
degree of emotional and/or 
physical discomfort. Probability 
of adverse events is low. 
Severity (magnitude) of adverse 
events is low. (Procedure may 
be rated as low if probability of 
AE is moderate to high as long 
as the severity is low, as in the 
case of a bruise from 
phlebotomy.) Procedures that 
meet IRB criteria for expedited 
review are commonly rated as 
low.  
1 point 
 
 
Moderate Risk  
 
Moderate degree of emotional 
and/or physical discomfort. 
Probability of adverse events is 
low. Severity of adverse events 
is moderate to high (e.g., PET 
scan, lumbar puncture, arterial 
lines).  
2 
points 
 
2 
High Risk 
Moderate to high degree of 
emotional and/or physical 
discomfort. Probability of 
adverse events is moderate to 
high. Severity of adverse events 
is high (e.g., heart muscle 
biopsy, insulin infusion).  
4 
points 
 
 
III. Decision-Making Capability  
Non-vulnerable  
Adult who (1) demonstrates 
decision-making capacity and 
(2) demonstrates no perception 
of undue influence or coercion 
to participate.  
1 point 
 
 

Vulnerable  
 
Any minor. Adult who (1) 
demonstrates limitations in 
decision-making capacity and/or 
(2) is prone to perception of 
undue influence or coercion to 
participate.  
2 
points 
Minors 
ages 15-17 
years old 
2 
TOTAL 
6 
*Adapted with permission from Slimmer et al., Western Journal of Nursing Research, 2004, 26(7), 
797-803. [170] 
 
Details on the family recruitment procedures, consent procedures, safety monitoring 
procedures, and the results on feasibility, acceptability, safety and tolerability have been 
published (please see Cluxton-Keller F, Hegel MT. A video-delivered family therapeutic 
intervention for perinatal women with clinically significant depressive symptoms and family 
conflict: Indicators of feasibility and acceptability. JMIR Form Res. 2022;6(10):e41697. doi: 
10.2196/41697. PMID: 36194458; and Cluxton-Keller F, Hegel MT, Donnelly CL, Bruce ML. 
Video-delivered family therapy for perinatal women with depressive symptoms and family 
conflict: Feasibility, acceptability, safety, and tolerability results from a pilot randomized trial. 
JMIR Form Res. 2023;7:e51824. doi: 10.2196/51824. PMID: 37921846). 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Statistical Analysis Plan 
Generalized linear mixed-effects models (GLMM) were used to analyze changes in mothers and 
family members, separately, with fixed effects for time (baseline, post-intervention, three-month, 
six-month follow-up), study group (Resilience Enhancement Skills Training, Standard of Care), 
and study group*time interaction. An intervention effect is indicated by a significant study 
group*time interaction with greater improvement in the Resilience Enhancement Skills Training 
group. Individual-level random intercept and slope terms were included to account for 
correlations from repeated measures. Significance of change from baseline to the six month 
follow-up was tested for mothers and family members, separately.  GLMM was used that 
accommodates intermittent missing data and attrition, and estimate is not biased assuming 
missing data mechanism is missing at random (MAR) [1]. The distinction between MAR and 
missing not at random is not verifiable using observed data [2]. However, we did not empirically 
observe systematic patterns of missing in the data for this study. While MAR is a plausible 
assumption in many cases, minor departures from MAR typically do not invalidate the results of 
an MAR-based analysis. [3-4]. 
References 
1. Fitzmaurice GM, Laird NM, Ware JH. Applied longitudinal analysis (2nd ed.). John Wiley & 
Sons, Inc. 2011. 
2. Hedeker D, Gibbons R. Longitudinal Data Analysis. 2006. Wiley-Interscience.  
3. Collins L, Schafer J,  Kam CM. A comparison of inclusive and restrictive strategies in 
modern missing-data procedures. Psychol Methods. 2001;(6):330-351. 
4. Schafer JL, Graham JW. Missing data: Our view of the state of the art. Psychol Methods. 
2002;7(2):147-177.