Trial Outcomes & Findings for A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers (NCT NCT04741776)
NCT ID: NCT04741776
Last Updated: 2025-01-08
Results Overview
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Higher score indicates greater depressive symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
166 participants
Primary outcome timeframe
Baseline and six month follow-up
Results posted on
2025-01-08
Participant Flow
Research staff obtained electronic consent of the IRB-approved consent forms for the eligibility screen and study enrollment from willing participants
The mother, and her family member, were randomized to one of two study groups: 1) video-based family therapy (Resilience Enhancement Skills Training, REST), or 2) standard of care (Video-based Problem Solving individual Therapy, V-PST). REST is designed for participation by the dyad. By design, only the mother participated in V-PST sessions. The Enrollment number and Started/Completed number represents individual participants.
Participant milestones
| Measure |
Video-based Family Therapy: Mothers
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Video-based Family Therapy: Family Members
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Mothers
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
41
|
41
|
|
Overall Study
Started Assigned Intervention
|
38
|
38
|
37
|
37
|
|
Overall Study
COMPLETED
|
35
|
32
|
30
|
24
|
|
Overall Study
NOT COMPLETED
|
7
|
10
|
11
|
17
|
Reasons for withdrawal
| Measure |
Video-based Family Therapy: Mothers
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Video-based Family Therapy: Family Members
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Mothers
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
7
|
10
|
10
|
17
|
|
Overall Study
Death
|
0
|
0
|
1
|
0
|
Baseline Characteristics
A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers
Baseline characteristics by cohort
| Measure |
Video-based Family Therapy: Mothers
n=42 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Video-based Family Therapy: Family Members
n=42 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Mothers
n=41 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care: Family Members
n=41 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Total
n=166 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
41 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
40 Participants
n=7 Participants
|
162 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
Age, Continuous
|
28.1 years
STANDARD_DEVIATION 5.7 • n=99 Participants
|
33.1 years
STANDARD_DEVIATION 11.4 • n=107 Participants
|
28.3 years
STANDARD_DEVIATION 5.5 • n=206 Participants
|
38.0 years
STANDARD_DEVIATION 14.6 • n=7 Participants
|
31.79 years
STANDARD_DEVIATION 10.78 • n=31 Participants
|
|
Sex: Female, Male
Female
|
42 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
13 Participants
n=7 Participants
|
101 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
37 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
28 Participants
n=7 Participants
|
65 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
42 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
37 Participants
n=7 Participants
|
159 Participants
n=31 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=99 Participants
|
25 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
25 Participants
n=7 Participants
|
106 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
9 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
39 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
42 Participants
n=99 Participants
|
42 Participants
n=107 Participants
|
41 Participants
n=206 Participants
|
41 Participants
n=7 Participants
|
166 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: All mothers who attended at least 1 session.
Maternal depressive symptoms. The Beck Depression Inventory-Second Edition scores range from 0 (no depressive symptoms) to 63 (severe depressive symptoms). Higher score indicates greater depressive symptoms.
Outcome measures
| Measure |
Video-based Family Therapy: Mothers
n=38 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions.
|
Standard of Care: Mothers
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions.
|
Standard of Care:Mothers
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|---|
|
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
Baseline
|
28.3 units on a scale (BDI-II)
Standard Deviation 5.8
|
27.0 units on a scale (BDI-II)
Standard Deviation 6.1
|
—
|
—
|
—
|
|
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
Six Month Follow-Up
|
6.9 units on a scale (BDI-II)
Standard Deviation 4.9
|
13.2 units on a scale (BDI-II)
Standard Deviation 8.6
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: baseline and six month follow-upFamily conflict was measured using the Perceived Hostility Survey (Ages 18 +) and Perceived Hostility Survey (Ages 8-17). In both versions of the Perceived Hostility Survey, raw scores are converted to uncorrected T-scores. Scores one standard deviation or more below the mean (T ≤ 40) suggest low levels of perceived hostility and scores one standard deviation or more above the mean (T ≥ 60) suggest high levels of perceived hostility.
Outcome measures
| Measure |
Video-based Family Therapy: Mothers
n=38 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions.
|
Standard of Care: Mothers
n=38 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions.
|
Standard of Care:Mothers
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|---|
|
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
Baseline
|
58.7 T-score
|
60.1 T-score
|
60.1 T-score
|
58.7 T-score
|
—
|
|
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up
Six month follow-up
|
44.2 T-score
|
46.3 T-score
|
52.9 T-score
|
52.9 T-score
|
—
|
PRIMARY outcome
Timeframe: baseline and six month follow-upPopulation: All participants who completed at least one session. By design, mothers' family members did not participate in the Standard of Care intervention sessions.
Family cohesion was measured using the Multidimensional Scale of Perceived Social Support-Family with scores that range from 7-28. Higher scores indicate greater cohesion.
Outcome measures
| Measure |
Video-based Family Therapy: Mothers
n=38 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions.
|
Standard of Care: Mothers
n=38 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions.
|
Standard of Care:Mothers
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|---|
|
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
Six month follow-up
|
23.7 units on a scale
Standard Deviation 3.4
|
24.0 units on a scale
Standard Deviation 2.8
|
19.3 units on a scale
Standard Deviation 6.0
|
20.9 units on a scale
Standard Deviation 6.7
|
—
|
|
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
Baseline
|
20.6 units on a scale
Standard Deviation 3.7
|
20.9 units on a scale
Standard Deviation 4.3
|
19.7 units on a scale
Standard Deviation 5.1
|
20.2 units on a scale
Standard Deviation 4.0
|
—
|
PRIMARY outcome
Timeframe: Baseline and six month follow-upPopulation: Participants who completed at least one session. By design, mothers' family members did not participate in Standard of Care intervention sessions.
Family cognitive reappraisal. Adult participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Adult version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 42 (frequent use of cognitive reappraisal). Adolescent participants completed the Emotion Regulation Questionnaire-Cognitive Reappraisal scale (Children and Adolescents version) with scores that range from 6 (infrequent use of cognitive reappraisal) to 30 (frequent use of cognitive reappraisal).
Outcome measures
| Measure |
Video-based Family Therapy: Mothers
n=37 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions.
|
Standard of Care: Mothers
n=1 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions.
|
Standard of Care:Mothers
n=38 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
n=37 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|---|
|
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
Baseline
|
23.5 units on a scale
Standard Deviation 5.7
|
18.0 units on a scale
Standard Deviation 0.0
|
28.1 units on a scale
Standard Deviation 7.7
|
25.8 units on a scale
Standard Deviation 5.7
|
31.6 units on a scale
Standard Deviation 5.8
|
|
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
Six month follow-up
|
31.6 units on a scale
Standard Deviation 5.8
|
—
|
32.5 units on a scale
Standard Deviation 6.8
|
30.2 units on a scale
Standard Deviation 5.4
|
34.3 units on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Change from baseline in maternal school enrollment/job attainment at 6 monthsPopulation: Mothers without circumstances that prevented them from obtaining employment and enrolling in school at baseline were included in analysis.
Adapted item from ABCD study.
Outcome measures
| Measure |
Video-based Family Therapy: Mothers
n=31 Participants
Resilience Enhancement Skills Training (REST) is the family therapy intervention. Mothers and their family members participated in REST sessions.
|
Standard of Care: Mothers
n=30 Participants
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions.
|
Standard of Care:Mothers
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
Standard of Care:Family Members
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. Study measures were administered to each mother and her family member, separately.
|
|---|---|---|---|---|---|
|
Maternal School Enrollment/Job Attainment
Baseline
|
11 Participants
|
12 Participants
|
—
|
—
|
—
|
|
Maternal School Enrollment/Job Attainment
Six month follow-up
|
23 Participants
|
13 Participants
|
—
|
—
|
—
|
Adverse Events
Video-based Family Therapy:Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Video-based Family Therapy: Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard of Care: Mothers
Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths
Standard of Care: Family Members
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Fallon Cluxton-Keller, Ph.D.
Dartmouth-Hitchcock Clinic
Phone: 603-650-4724
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place