Craig L. Donnelly

A significant portion of mothers (pregnant and postpartum) enrolled in U.S. home visiting programs report clinically significant depressive symptoms. Non‐violent family conflict precipitates and exacerbates their depressive symptoms. This pilot randomized trial tested the preliminary effectiveness of a family therapy intervention, Resilience Enhancement Skills Training (REST), compared to the standard of care in home‐visited mothers with moderate to severe depressive symptoms and moderate to high conflict with family members. A total of 83 mothers and their family members (N = 166) were randomized to receive REST or the standard of care. Both interventions were delivered by clinicians using HIPAA‐compliant video conferencing technology. Outcomes were assessed by research assistants, blinded to study group assignment, at post‐intervention, 3, and 6 months later. Linear mixed‐effects models were used to analyze changes in continuous outcomes in mothers and family members, separately. Mixed‐effects logistic regression was used to analyze changes in maternal job attainment/school enrollment. Participants in both study groups showed improvements in outcomes. When compared to standard‐of‐care participants, REST participants had significantly greater reductions in family conflict (mothers ES = −1.19, family members ES = −0.77), maternal depressive symptoms (ES = −0.96) and co‐occurring anxiety symptoms (ES = −0.59), and greater increases in family cohesion (mothers ES = 0.99, family members ES = 0.94) and maternal job attainment/school enrollment (ES = 0.70). The results highlight the value of family therapy for the treatment of moderate to severe depressive symptoms in home‐visited mothers, including those with co‐occurring moderate to severe anxiety symptoms.Trial Registration: Registered in ClinicalTrials.gov on 02/04/2021. NCT04741776 https://clinicaltrials.gov/ct2/show/NCT04741776

Background: Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act–compliant videoconferencing technology (VCT). Objective: This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. Methods: This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. Results: On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. Conclusions: The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST’s preliminary effectiveness upon completion of outcome data collection. Trial Registration: ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776

BACKGROUND Although individual-level treatments exist for pregnant and postpartum women with depression, family conflict is a significant factor that can contribute to the development and severity of perinatal depressive symptoms. Yet, there is a lack of research on family therapy for perinatal women with moderate to severe depressive symptoms and family conflict. Further, research is needed on the feasibility, acceptability, safety, and tolerability of family therapies for perinatal depression that are delivered using Health Insurance Portability and Accountability Act–compliant videoconferencing technology (VCT). OBJECTIVE This paper describes the feasibility, acceptability, safety, and tolerability of a VCT-based family therapeutic intervention, Resilience Enhancement Skills Training (REST), for perinatal women with moderate to severe depressive symptoms and moderate to high conflict with their family members. METHODS This paper includes data from an ongoing randomized trial that compares an experimental family therapeutic intervention (REST) to standard of care (VCT-based problem-solving individual therapy) for the treatment of moderate to severe depressive symptoms in perinatal women with moderate to high family conflict. Both interventions were delivered by masters-level therapists using VCT. A total of 83 perinatal women and their adult family members (N=166 individuals) were recruited for participation in the study. Feasibility, defined as therapist adherence to ≥80% of REST session content, was assessed in audio-recorded sessions by 2 expert raters. Acceptability was defined as ≥80% of families completing REST, including completion of ≥80% homework assignments and family report of satisfaction with REST. Completion of REST was assessed by review of therapist session notes, and satisfaction was assessed by participant completion of a web-based questionnaire. The Beck Depression Inventory-Second Edition was administered to perinatal women by research assistants (blind to study group assignment) to assess safety, defined as a reduction in depressive symptoms during the treatment phase. The Family Environment Scale-Family Conflict subscale was administered by therapists to participants during the treatment phase to assess tolerability, defined as a reduction in family conflict during the treatment phase. RESULTS On average, the therapists achieved 90% adherence to REST session content. Of the families who started REST, 84% (32/38) of them completed REST, and on average, they completed 89% (8/9) of the homework assignments. Families reported satisfaction with REST. The results showed that REST is safe for perinatal women with moderate to severe depressive symptoms, and none discontinued due to worsened depressive symptoms. The results showed that REST is well tolerated by families, and no families discontinued due to sustained family conflict. CONCLUSIONS The results show that REST is feasible, acceptable, safe, and tolerable for families. These findings will guide our interpretation of REST’s preliminary effectiveness upon completion of outcome data collection. CLINICALTRIAL ClinicalTrials.gov NCT04741776; https://clinicaltrials.gov/ct2/show/NCT04741776

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).

Journal of Medical Internet Research - International Scientific Journal for Medical Research, Information and Communication on the Internet #Preprint #PeerReviewMe: Warning: This is a unreviewed preprint. Readers are warned that the document has not been peer-reviewed by expert/patient reviewers or an academic editor, may contain misleading claims, and is likely to undergo changes before final publication, if accepted, or may have been rejected/withdrawn. Readers with interest and expertise are encouraged to sign up as peer-reviewer, if the paper is within an open peer-review period. Please cite this preprint only for review purposes or for grant applications and CVs (if you are the author).

Background: The Federal Maternal, Infant, and Early Childhood Home Visiting Program is a national child abuse prevention strategy that serves families at risk for child maltreatment throughout the United States. Significant portions of the clients are young mothers who screen positive for clinically significant perinatal depressive symptoms and experience relational discord that worsens their symptoms. Although home visitors refer those who screen positive for depression to community-based treatment, they infrequently obtain treatment because of multiple barriers. These barriers are compounded for home visited families in rural areas. Objective: This pilot study aimed to explore the feasibility, acceptability, and effectiveness of a video-delivered family therapy intervention on reducing maternal depressive symptoms and improving family functioning and emotion regulation. Methods: A total of 13 home visited families received the video-delivered family therapy intervention. This study included a historical comparison group of mothers (N=13) who were previously enrolled in home visiting and screened positive for clinically significant perinatal depressive symptoms but refused treatment. A licensed marriage and family therapist delivered the family therapy intervention using Health Insurance Portability and Accountability Act–compliant videoconferencing technology on a computer from an office. Families participated in sessions in their homes using cell phones, tablets, and computers equipped with microphones and video cameras. Outcomes were measured following the final therapy session (post intervention) and 2 months later (follow-up). Depressive symptom scores of mothers who received the video-delivered family therapy intervention were compared with those of mothers in the historical comparison group over a 6-month period. Univariate statistics and correlations were calculated to assess measures of feasibility. Percentages and qualitative thematic analysis were used to assess acceptability. Wilcoxon signed-rank tests were used to assess changes in maternal and family outcomes. Results: No families dropped out of the study. All families reported that the technology was convenient and easy to use. All families reported high satisfaction with the video-delivered intervention. Nearly all families reported that they preferred video-delivered family therapy instead of clinic-based therapy. Therapeutic alliance was strong. Mothers demonstrated a statistically significant reduction in depressive symptoms (P=.001). When compared with mothers in the historical comparison group, those in the family therapy intervention showed a significant reduction in depressive symptoms (P=.001). Families demonstrated statistically significant improvements in family functioning (P=.02) and cognitive reappraisal (P=.004). Conclusions: This pilot study yielded preliminary findings that support the feasibility, acceptability, and effectiveness of the video-delivered family therapy intervention for underserved home visited families in rural areas. Our findings are very promising, but more research is needed to ultimately influence mental health practices and policies that pertain to video-delivered mental health interventions in unsupervised settings (eg, homes).

BACKGROUND The Federal Maternal, Infant, and Early Childhood Home Visiting Program is a national child abuse prevention strategy that serves families at risk for child maltreatment throughout the United States. Significant portions of the clients are young mothers who screen positive for clinically significant perinatal depressive symptoms and experience relational discord that worsens their symptoms. Although home visitors refer those who screen positive for depression to community-based treatment, they infrequently obtain treatment because of multiple barriers. These barriers are compounded for home visited families in rural areas. OBJECTIVE This pilot study aimed to explore the feasibility, acceptability, and effectiveness of a video-delivered family therapy intervention on reducing maternal depressive symptoms and improving family functioning and emotion regulation. METHODS A total of 13 home visited families received the video-delivered family therapy intervention. This study included a historical comparison group of mothers (N=13) who were previously enrolled in home visiting and screened positive for clinically significant perinatal depressive symptoms but refused treatment. A licensed marriage and family therapist delivered the family therapy intervention using Health Insurance Portability and Accountability Act–compliant videoconferencing technology on a computer from an office. Families participated in sessions in their homes using cell phones, tablets, and computers equipped with microphones and video cameras. Outcomes were measured following the final therapy session (post intervention) and 2 months later (follow-up). Depressive symptom scores of mothers who received the video-delivered family therapy intervention were compared with those of mothers in the historical comparison group over a 6-month period. Univariate statistics and correlations were calculated to assess measures of feasibility. Percentages and qualitative thematic analysis were used to assess acceptability. Wilcoxon signed-rank tests were used to assess changes in maternal and family outcomes. RESULTS No families dropped out of the study. All families reported that the technology was convenient and easy to use. All families reported high satisfaction with the video-delivered intervention. Nearly all families reported that they preferred video-delivered family therapy instead of clinic-based therapy. Therapeutic alliance was strong. Mothers demonstrated a statistically significant reduction in depressive symptoms (P=.001). When compared with mothers in the historical comparison group, those in the family therapy intervention showed a significant reduction in depressive symptoms (P=.001). Families demonstrated statistically significant improvements in family functioning (P=.02) and cognitive reappraisal (P=.004). CONCLUSIONS This pilot study yielded preliminary findings that support the feasibility, acceptability, and effectiveness of the video-delivered family therapy intervention for underserved home visited families in rural areas. Our findings are very promising, but more research is needed to ultimately influence mental health practices and policies that pertain to video-delivered mental health interventions in unsupervised settings (eg, homes).