Trial Outcomes & Findings for A Pilot Randomized Trial of Video-based Family Therapy for Depressed Home Visited Mothers (NCT 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

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

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

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

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=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	0 Participants n=4 Participants	2 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	41 Participants n=5 Participants	41 Participants n=7 Participants	40 Participants n=5 Participants	40 Participants n=4 Participants	162 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	2 Participants n=21 Participants
Age, Continuous	28.1 years STANDARD_DEVIATION 5.7 • n=5 Participants	33.1 years STANDARD_DEVIATION 11.4 • n=7 Participants	28.3 years STANDARD_DEVIATION 5.5 • n=5 Participants	38.0 years STANDARD_DEVIATION 14.6 • n=4 Participants	31.79 years STANDARD_DEVIATION 10.78 • n=21 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	5 Participants n=7 Participants	41 Participants n=5 Participants	13 Participants n=4 Participants	101 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	37 Participants n=7 Participants	0 Participants n=5 Participants	28 Participants n=4 Participants	65 Participants n=21 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants	7 Participants n=21 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	39 Participants n=7 Participants	41 Participants n=5 Participants	37 Participants n=4 Participants	159 Participants n=21 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	2 Participants n=4 Participants	7 Participants n=21 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants	2 Participants n=4 Participants	8 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	5 Participants n=21 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants	25 Participants n=7 Participants	28 Participants n=5 Participants	25 Participants n=4 Participants	106 Participants n=21 Participants
Race (NIH/OMB) More than one race	9 Participants n=5 Participants	12 Participants n=7 Participants	7 Participants n=5 Participants	11 Participants n=4 Participants	39 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	42 Participants n=5 Participants	42 Participants n=7 Participants	41 Participants n=5 Participants	41 Participants n=4 Participants	166 Participants n=21 Participants

PRIMARY outcome

Timeframe: Baseline and six month follow-up

Population: All mothers who attended at least 1 session.

Outcome measures

Outcome measures
Measure	Video-based Family Therapy:Adolescent Mother n=37 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 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:Adult 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.	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. 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	27.0 units on a scale (BDI-II) Standard Deviation 6.1	—	—	—	28.3 units on a scale (BDI-II) Standard Deviation 5.8
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up Six Month Follow-Up	13.2 units on a scale (BDI-II) Standard Deviation 8.6	—	—	—	6.9 units on a scale (BDI-II) Standard Deviation 4.9

PRIMARY outcome

Timeframe: baseline and six month follow-up

Family 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

Outcome measures
Measure	Video-based Family Therapy:Adolescent Mother n=38 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=37 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:Adult 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 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.	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. 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	60.1 T-score	60.1 T-score	58.7 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	46.3 T-score	52.9 T-score	52.9 T-score	—	44.2 T-score

PRIMARY outcome

Timeframe: baseline and six month follow-up

Population: 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

Outcome measures
Measure	Video-based Family Therapy:Adolescent Mother n=38 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=37 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:Adult 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 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.	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. 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 Baseline	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	—	20.6 units on a scale Standard Deviation 3.7
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	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	—	23.7 units on a scale Standard Deviation 3.4

PRIMARY outcome

Timeframe: Baseline and six month follow-up

Population: 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

Outcome measures
Measure	Video-based Family Therapy:Adolescent Mother n=1 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=38 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:Adult 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.	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. 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	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	23.5 units on a scale Standard Deviation 5.7
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up Six month follow-up	—	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	31.6 units on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: Change from baseline in maternal school enrollment/job attainment at 6 months

Population: 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

Outcome measures
Measure	Video-based Family Therapy:Adolescent Mother n=30 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 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:Adult 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.	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. Study measures were administered to each mother and her family member, separately.
Maternal School Enrollment/Job Attainment Baseline	12 Participants	—	—	—	11 Participants
Maternal School Enrollment/Job Attainment Six month follow-up	13 Participants	—	—	—	23 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