Family Conflict, Perinatal Depression, Postpartum Depression
Conditions
Brief summary
Depressed mothers (pregnant and post-delivery) make up a significant portion of Maternal, Infant, and Early Childhood Home Visiting (MIECHV) clients. Home visited mothers often experience family conflict that precipitates or worsens their depressive symptoms. This study uses an effectiveness-implementation hybrid type 1 design with a pilot randomized trial to test the feasibility, acceptability, tolerability, safety, and preliminary effectiveness of an innovative family therapy intervention that uses technology to bypass barriers to increase access to treatment for this vulnerable population.
Interventions
BEHAVIORALResilience Enhancement Skills Training
Family therapy
BEHAVIORALProblem-Solving Individual Therapy
Individual therapy
Sponsors
National Institute of Mental Health (NIMH)
Dartmouth-Hitchcock Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mothers in any trimester of pregnancy through 18 months postpartum who are enrolled in home visiting at a participating agency; * Fluent in English; * Mother and her family member have at least an 8th grade education; * Mothers with Beck Depression Inventory-Second Edition scores of at least 20; * Perceived Hostility Survey-Adult raw scores of at least 16 for the adult mother and her adult family member; Perceived Hostility Survey-Child raw scores of at least 14 for the adolescent mother and her adolescent intimate partner; and * Consistent internet access on their cell phones, tablets, or computer equipped with a microphone and camera.
Exclusion criteria
* Suicidal ideation in the mother and/or her family member; * Mothers with bipolar disorder symptoms; * Psychotic symptoms in the mother and/or her family member; * Mother is currently receiving individual therapy; * Family is currently receiving family therapy; * Mothers who have been taking an antidepressant for less than 2 months; and * Families with domestic violence.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up | Baseline and six month follow-up | 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. |
| Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | 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. |
| Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up | baseline and six month follow-up | 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. |
| Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Baseline and six month follow-up | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal School Enrollment/Job Attainment | Change from baseline in maternal school enrollment/job attainment at 6 months | Adapted item from ABCD study. |
Countries
United States
Participant flow
Recruitment details
Research staff obtained electronic consent of the IRB-approved consent forms for the eligibility screen and study enrollment from willing participants
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 42 |
| 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. | 42 |
| 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. | 41 |
| 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. | 41 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Death | 0 | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 7 | 10 | 10 | 17 |
Baseline characteristics
| Characteristic | Video-based Family Therapy: Mothers | Video-based Family Therapy: Family Members | Standard of Care: Mothers | Standard of Care: Family Members | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 1 Participants | 0 Participants | 1 Participants | 0 Participants | 2 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 41 Participants | 41 Participants | 40 Participants | 40 Participants | 162 Participants |
| Age, Continuous | 28.1 years STANDARD_DEVIATION 5.7 | 33.1 years STANDARD_DEVIATION 11.4 | 28.3 years STANDARD_DEVIATION 5.5 | 38.0 years STANDARD_DEVIATION 14.6 | 31.79 years STANDARD_DEVIATION 10.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 3 Participants | 0 Participants | 4 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants | 39 Participants | 41 Participants | 37 Participants | 159 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 2 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 1 Participants | 1 Participants | 1 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 9 Participants | 12 Participants | 7 Participants | 11 Participants | 39 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 25 Participants | 28 Participants | 25 Participants | 106 Participants |
| Region of Enrollment United States | 42 Participants | 42 Participants | 41 Participants | 41 Participants | 166 Participants |
| Sex: Female, Male Female | 42 Participants | 5 Participants | 41 Participants | 13 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 37 Participants | 0 Participants | 28 Participants | 65 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 42 | 0 / 42 | 1 / 41 | 0 / 41 |
| other Total, other adverse events | 0 / 42 | 0 / 42 | 0 / 41 | 0 / 41 |
| serious Total, serious adverse events | 0 / 42 | 0 / 42 | 0 / 41 | 0 / 41 |
Outcome results
Primary
Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Family Therapy: Mothers | 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 |
| Video-based Family Therapy: Mothers | 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 |
| Standard of Care: Mothers | 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 |
| Standard of Care:Mothers | 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 |
| Standard of Care:Mothers | Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Baseline | 28.1 units on a scale | Standard Deviation 7.7 |
| Standard of Care:Family Members | Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Baseline | 25.8 units on a scale | Standard Deviation 5.7 |
| Standard of Care:Family Members | Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Six month follow-up | 30.2 units on a scale | Standard Deviation 5.4 |
| Standard of Care:Family Members | Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Six month follow-up | 34.3 units on a scale | Standard Deviation 5.8 |
| Standard of Care:Family Members | Change From Baseline in Cognitive Reappraisal on the Emotion Regulation Questionnaire-Cognitive Reappraisal Scale at Six Month Follow-up | Baseline | 31.6 units on a scale | Standard Deviation 5.8 |
Primary
Change From Baseline in Depressive Symptoms on the Beck Depression Inventory-Second Edition at Six Month Follow-up
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.
Time frame: Baseline and six month follow-up
Population: All mothers who attended at least 1 session.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Family Therapy: Mothers | 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 |
| Video-based Family Therapy: Mothers | 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 |
| Standard of Care: Mothers | 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 |
| Standard of Care: Mothers | 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 |
Primary
Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Video-based Family Therapy: Mothers | 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 |
| Video-based Family Therapy: Mothers | 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 |
| Standard of Care: Mothers | 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 |
| Standard of Care: Mothers | 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 |
| Standard of Care:Mothers | 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 | 19.3 units on a scale | Standard Deviation 6 |
| Standard of Care:Mothers | Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up | Baseline | 19.7 units on a scale | Standard Deviation 5.1 |
| Standard of Care:Family Members | 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 | 20.9 units on a scale | Standard Deviation 6.7 |
| Standard of Care:Family Members | Change From Baseline in Family Cohesion on the Multidimensional Scale of Perceived Social Support-Family at the Six Month Follow-up | Baseline | 20.2 units on a scale | Standard Deviation 4 |
Primary
Change From Baseline in Family Conflict on the Perceived Hostility Survey at the 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.
Time frame: baseline and six month follow-up
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Video-based Family Therapy: Mothers | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Baseline | 58.7 T-score |
| Video-based Family Therapy: Mothers | 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 |
| Standard of Care: Mothers | 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 |
| Standard of Care: Mothers | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Baseline | 60.1 T-score |
| Standard of Care:Mothers | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Six month follow-up | 52.9 T-score |
| Standard of Care:Mothers | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Baseline | 60.1 T-score |
| Standard of Care:Family Members | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Six month follow-up | 52.9 T-score |
| Standard of Care:Family Members | Change From Baseline in Family Conflict on the Perceived Hostility Survey at the Six Month Follow-up | Baseline | 58.7 T-score |
Secondary
Maternal School Enrollment/Job Attainment
Adapted item from ABCD study.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Video-based Family Therapy: Mothers | Maternal School Enrollment/Job Attainment | Baseline | 11 Participants |
| Video-based Family Therapy: Mothers | Maternal School Enrollment/Job Attainment | Six month follow-up | 23 Participants |
| Standard of Care: Mothers | Maternal School Enrollment/Job Attainment | Baseline | 12 Participants |
| Standard of Care: Mothers | Maternal School Enrollment/Job Attainment | Six month follow-up | 13 Participants |