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| ID | Type | Description | Link |
|---|---|---|---|
| 1R34MH124951 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Mental Health (NIMH) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Video-based family therapy | Experimental | Resilience Enhancement Skills Training (REST) |
|
| Standard of care | Active Comparator | Video-based Problem Solving individual Therapy (V-PST) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Resilience Enhancement Skills Training | Behavioral | Family therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and six month follow-up |
| 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. | baseline and six month follow-up |
| 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. | baseline and six month follow-up |
| 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). | Baseline and six month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal School Enrollment/Job Attainment | Adapted item from ABCD study. | Change from baseline in maternal school enrollment/job attainment at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Fallon Cluxton-Keller, Ph.D. | Dartmouth-Hitchcock Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth-Hitchcock Clinic | Lebanon | New Hampshire | 03756 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40159324 | Derived | Cluxton-Keller F, Xie H, Hegel MT, Donnelly CL, Bruce ML. Preliminary Effectiveness of Family Therapy for Perinatal Depressive Symptoms: Results From a Pilot Randomized Trial. Fam Process. 2025 Jun;64(2):e70032. doi: 10.1111/famp.70032. | |
| 37921846 | Derived | 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 Nov 3;7:e51824. doi: 10.2196/51824. |
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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.
Research staff obtained electronic consent of the IRB-approved consent forms for the eligibility screen and study enrollment from willing participants
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Video-based Family Therapy: Family Members |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | All mothers who attended at least 1 session. | Posted | Mean | Standard Deviation | units on a scale (BDI-II) | Baseline and six month follow-up |
|
Nine months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Fallon Cluxton-Keller, Ph.D. | Dartmouth-Hitchcock Clinic | 603-650-4724 | Fallon.P.Cluxton-Keller@dartmouth.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 8, 2020 | Nov 7, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Problem-Solving Individual Therapy |
| Behavioral |
Individual therapy |
|
| 36194458 | Derived | 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 Oct 4;6(10):e41697. doi: 10.2196/41697. |
| Death |
|
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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
Video-based Problem-Solving individual Therapy (V-PST) is the active comparison condition. Only mothers participated in V-PST sessions. |
|
|
| 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. | Posted | Number | T-score | baseline and six month follow-up |
|
|
|
| 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. | All participants who completed at least one session. By design, mothers' family members did not participate in the Standard of Care intervention sessions. | Posted | Mean | Standard Deviation | units on a scale | baseline and six month follow-up |
|
|
|
| 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). | Participants who completed at least one session. By design, mothers' family members did not participate in Standard of Care intervention sessions. | Posted | Mean | Standard Deviation | units on a scale | Baseline and six month follow-up |
|
|
|
| Secondary | Maternal School Enrollment/Job Attainment | Adapted item from ABCD study. | Mothers without circumstances that prevented them from obtaining employment and enrolling in school at baseline were included in analysis. | Posted | Count of Participants | Participants | Change from baseline in maternal school enrollment/job attainment at 6 months |
|
|
|
| 0 |
| 42 |
| 0 |
| 42 |
| 0 |
| 42 |
| EG001 | 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. | 0 | 42 | 0 | 42 | 0 | 42 |
| EG002 | 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. | 1 | 41 | 0 | 41 | 0 | 41 |
| EG003 | 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. | 0 | 41 | 0 | 41 | 0 | 41 |
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| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
| Six month follow-up |
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| Six month follow-up |
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| Six month follow-up |
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| Six month follow-up |
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