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An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial.

ABSTRACT: Background:The Federal Maternal, Infant, and Early Childhood Home Visiting (HV) Program serves over 100,000 vulnerable families at risk for child abuse in the USA and aims to improve many outcomes, including maternal mental health (HRSA's Federal Home Visiting Program: partnering with parents to help children succeed, 2017). Most clients are insured by Medicaid, and about 40% are adolescent mothers (pregnant and post-delivery) (The mother and infant home visiting program evaluation: early findings on the Maternal, Infant, and Early Childhood Home Visiting Program, 2015). Over a third of home-visited clients report peripartum depressive symptoms (The mother and infant home visiting program evaluation: early findings on the Maternal, Infant, and Early Childhood Home Visiting Program, 2015). Family conflict increases rates of peripartum depression in adolescent mothers (J Ped Health Care 21:289-98, 2007; J Emot Behav Disord 5:173-83, 1997; Fam Relat 47:395-402, 1998; Arch Ped Adolesc Med 150:64-9, 1996; Obstet Gynecol 110:134-40, 2007; Am Fam Physician 93:852-58, 2016). Although home visitors screen for depression and refer those with positive screens for treatment (The mother and infant home visiting program evaluation: early findings on the Maternal, Infant, and Early Childhood Home Visiting Program, 2015), home-visited mothers infrequently obtain treatment or do not complete it if they do obtain it (Curr Probl Ped Adolesc Health Care 46:124-9, 2016; Making a difference in the lives of children and families: the impacts of Early Head Start Programs on infants and toddlers and their families, 2002; Depression and low-income women: challenges for TANF and welfare-to-work policies and programs, 2001; Aggress Violent Behav 15:191-200, 2010) due to many barriers (e.g., lack of child care, lack of transportation, geographical distance) (Arch Gen Psychiatry 68:627-36, 2011). There is a need for a video-based, family-oriented treatment for peripartum depression that is integrated into home visiting and would bypass these barriers. This article outlines a protocol for a pilot study that will explore the feasibility and acceptability of implementing a family-based treatment, using HIPAA-compliant video-based communication technology, for adolescents with peripartum depressive symptoms within the context of home visiting. Methods:This study protocol includes a description of an implementation-effectiveness hybrid trial design that will include 12 depressed adolescent mothers and their family members and a historical comparison group of 12 previously enrolled adolescent mothers. Discussion:The study results will provide a clearer understanding of whether or not video-based, family-oriented treatment is feasible and acceptable to implement within the context of home visiting and with home-visited adolescents with peripartum depressive symptoms. The findings from this pilot study could serve as a catalyst for future research that influences mental health practices and policies. Trial registration:NCT03282448, ClinicalTrials.gov date of registration 09/21/2017.

SUBMITTER: Cluxton-Keller F

PROVIDER: S-EPMC5683555 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature

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An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial.

Cluxton-Keller Fallon F Donnelly Craig L CL Williams Melony M Buteau Jennifer J Stolte Patricia P Monroe-Cassel Maggie M Bruce Martha L ML

Pilot and feasibility studies 20171113

<h4>Background</h4>The Federal Maternal, Infant, and Early Childhood Home Visiting (HV) Program serves over 100,000 vulnerable families at risk for child abuse in the USA and aims to improve many outcomes, including maternal mental health (HRSA's Federal Home Visiting Program: partnering with parents to help children succeed, 2017). Most clients are insured by Medicaid, and about 40% are adolescent mothers (pregnant and post-delivery) (The mother and infant home visiting program evaluation: earl ...[more]

PMID: 29158913

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Project description: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).

Project description:To address uncertainties prior to conducting a fully powered randomised controlled trial of Morita Therapy plus treatment as usual (TAU) versus TAU alone, or to determine that such a trial is not appropriate and/or feasible.Pilot parallel group randomised controlled feasibility trial.Participants aged ?18 years with Diagnostic and Statistical Manual of Mental Disorders (DSM)-IV major depressive disorder, with or without DSM-IV anxiety disorder(s), recruited from general practice record searches in Devon, UK.We randomised participants on a 1:1 basis stratified by symptom severity, concealing allocation using a secure independent web-based system, to receive TAU (control) or 8-12 sessions of Morita Therapy, a Japanese psychological therapy, plus TAU (intervention).Rates of recruitment, retention and treatment adherence; variance and estimated between-group differences in follow-up scores (on the Patient Health Questionnaire 9 (PHQ-9) (depressive symptoms); Generalised Anxiety Disorder Questionnaire 7 (anxiety symptoms); Short Form 36 Health Survey Questionnaire/Work and Social Adjustment Scale (quality of life); Morita Attitudinal Scale for Arugamama (attitudes)) and their correlation with baseline scores.We recruited 68 participants, 5.1% (95% CI 3.4% to 6.6%) of those invited (34 control; 34 intervention); 64/68 (94%; 95% CI 88.3% to 99.7%) provided 4-month follow-up data. Participants had a mean age of 49 years and mean PHQ-9 score of 16.8; 61% were female. Twenty-four of 34 (70.6%) adhered to the minimum treatment dose. The follow-up PHQ-9 (future primary outcome measure) pooled SD was 6.4 (95% CI 5.5 to 7.8); the magnitude of correlation between baseline and follow-up PHQ-9 scores was 0.42 (95% CI 0.19 to 0.61). Of the participants, 66.7% and 30.0% recovered in the intervention and control groups, respectively; 66.7% and 13.3% responded to treatment in the intervention and control groups, respectively.A large-scale trial of Morita Therapy would require 133 participants per group and is feasible with minor modifications to the pilot trial protocol. Morita Therapy shows promise in treating depression and may provide patients with a distinct alternative to current treatments.ISRCTN17544090; Pre-results.

Project description:BackgroundPeripartum depression is a leading cause of disease burden for women and yet there is little evidence as to how often peripartum depression does not respond to treatment and becomes treatment resistant depression. We sought to determine the incidence of treatment resistant depression (TRD) in women with peripartum depression.MethodsPopulation based retrospective cohort study using a large US claims database. Peripartum depression was defined as having a depression diagnosis during pregnancy or up to 6 months after the end of pregnancy. We included women with prevalent or incident depression. The outcome was the development of TRD within 1 year after the diagnosis of peripartum depression. TRD was defined as having 3 distinct antidepressants or 1 antidepressant and 1 antipsychotic in 1 year. Women with peripartum depression may not be exposed to pharmacological treatments early in pregnancy, therefore we created two groups: 1. women with peripartum depression, and 2. women with peripartum depression diagnosed 3 months before a live birth delivery or within 6 months after that delivery.ResultsThere were 3,207,684 pregnant women, of whom 2.5% had peripartum depression. Of these women half had incident depression during pregnancy. Five percent of women with peripartum depression developed TRD within 1 year of the depression diagnosis. The risk of developing TRD was 50% higher in women with prevalent depression than in women with incident peripartum depression (P < 0.0001). Results were similar in women with peripartum depression diagnosed later in their pregnancy. Women who went on to develop TRD had more substance use disorders, anxiety, insomnia and painful conditions.ConclusionsTRD occurs in approximately 5% of women with peripartum depression. The risk of TRD is higher in pregnant women with a history of depression. Women who went on to develop TRD had more psychiatric comorbidities and painful conditions than women who did not.

Project description:Measured objectively, less than a quarter of adults and under half of preschool children in Finland meet the physical activity recommendations. Moreover, higher sedentary time among parents (such as watching television) is associated with higher sedentary time of their children. The study introduces an intervention based on reducing sedentary behavior among mothers and their children. It utilizes a combination of music and exercise via a motivation-targeting movement-to-music video program in the home environment. Data were collected in summer 2014 from Finland's Pirkanmaa region. Each mother-child pair (n = 24, child age: 4-7 years) was assigned to the intervention and control group. Both groups used an accelerometer and completed physical activity diaries for two consecutive weeks (14 days) during waking hours. In addition, the intervention group was instructed to use the movement-to-music video program during the second week. Differences between groups were expected in analysis of sedentary time and physical activity between weeks 1 and 2. The parameters assessed were sedentary time (i.e., lying down or sitting), standing still, and time spent in physical activity. Less sedentary time was revealed in week 2 than in week 1 among both intervention group mothers (56.6 vs. 53.3 %) and for intervention group children (49.5 vs. 46.0 %). The opposite was true of control group mothers (52.1 vs. 52.4 %) and children (46.7 vs. 49.8 %). Within-group differences in mothers' sedentary time correlated moderately with the children's sedentary time (Spearman's r = 0.56). All groups exhibited slightly more standing in the second week than in week 1. Both sets of intervention participants also engaged in more light physical activity in week 2, with the opposite evident for the two control sets. In all groups, except the control children, the proportion of moderate to vigorous physical activity was higher in the second week than the first. The use of music and video content together may yield added benefits in efforts to reduce sedentary behavior and increase physical activity among mothers and their children in the home environment.

Project description:ObjectivesAdvance care planning (ACP) is important to ensure that nursing home (NH) residents receive care concordant with their goals. Video interventions have been developed to improve the process of ACP. Yet, little is known about which NH characteristics are associated with implementation of ACP video interventions in clinical practice. Our objective was to examine NH-level characteristics associated with the implementation of an ACP video intervention as part of the Pragmatic trial of Video Education in Nursing Homes (PROVEN) trial.DesignCross-sectional study of NHs in PROVEN.Setting and participants119 NHs randomized to receive the ACP video intervention.MeasurementsThe outcomes were the proportion of short- (<100 days) and long-stay (≥100 days) NH residents who were (1) offered to watch a video and (2) shown a video, aggregated to the NH-level, and measured using electronic forms of video offers. The association between outcomes and NH facility characteristics (eg, staffing, resident acuity) and participation in other aspects of the PROVEN trial (eg, monthly check-in calls) were estimated using multivariate linear regression models. NH characteristics were measured using data from Online Survey Certification and Reporting data, Long-term Care: Facts on Care in the US and NH Compare.ResultsOffer rates were 69% [standard deviation (SD): 28] for short-stay and 56% (SD: 20) for long-stay residents. Show rates were 19% (SD: 21) for short-stay and 17% (SD: 17) for long-stay residents. After adjusting for NH characteristics, compared to 1-star NHs, higher star-rated NHs had higher offer rates. Champions' participation in check-in calls was positively associated with both outcomes for long-stay residents.Conclusions/implicationsLower-quality NHs seem unable to integrate a novel ACP video education program into routine care processes. Ongoing support for and engagement with NH staff to champion the intervention throughout implementation is important for the success of a pragmatic trial within NHs.

Project description:BackgroundNursing home patients have complex mental and physical health problems, disabilities and social needs, combined with widespread prescription of psychotropic drugs. Preservation of their quality of life is an important goal. This can only be achieved within nursing homes that offer competent clinical conditions of treatment and care. COmmunication, Systematic assessment and treatment of pain, Medication review, Occupational therapy, Safety (COSMOS) is an effectiveness-implementation hybrid trial that combines and implements organization of activities evidence-based interventions to improve staff competence and thereby the patients' quality of life, mental health and safety. The aim of this paper is to describe the development, content and implementation process of the COSMOS trial.Methods/designCOSMOS includes a 2-month pilot study with 128 participants distributed among nine Norwegian nursing homes, and a 4-month multicenter, cluster randomized effectiveness-implementation clinical hybrid trial with follow-up at month 9, including 571 patients from 67 nursing home units (one unit defined as one cluster). Clusters are randomized to COSMOS intervention or current best practice (control group). The intervention group will receive a 2-day education program including written guidelines, repeated theoretical and practical training (credited education of caregivers, physicians and nursing home managers), case discussions and role play. The 1-day midway evaluation, information and interviews of nursing staff and a telephone hotline all support the implementation process. Outcome measures include quality of life in late-stage dementia, neuropsychiatric symptoms, activities of daily living, pain, depression, sleep, medication, cost-utility analysis, hospital admission and mortality.DiscussionDespite complex medical and psychosocial challenges, nursing home patients are often treated by staff possessing low level skills, lacking education and in facilities with a high staff turnover. Implementation of a research-based multicomponent intervention may improve staff's knowledge and competence and consequently the quality of life of nursing home patients in general and people with dementia in particular.Trial registrationClinicalTrials.gov NCT02238652.

Project description:BackgroundHome visiting is a well-supported strategy for addressing maternal and child health disparities. However, evidence-based models generally share implementation challenges at scale, including engagement and retention of families. Precision home visiting may address this issue. This paper describes the first known pilot randomized implementation trial of a precision home visiting approach vs. standard implementation. Primary aims are to: 1) explore the acceptability and feasibility of a precision approach to home visiting and 2) examine the difference between Standard Family Spirit and Precision Family Spirit on participants' program satisfaction, client-home visitor relationship, goal alliance, and the impact of these factors on participant engagement and retention. Secondary aims are to explore potential differences on maternal behavioral and mental health outcomes and child development outcomes to inform sample size estimations for a fully powered study.MethodsThis is a pilot Hybrid Type 3 implementation trial. Four Michigan communities primarily serving the Native American families and already using Family Spirit were randomized by site to receive Standard Family Spirit or Precision Family Spirit. Participants include N = 60 mothers at least 14 years of age (pregnant or with a newborn < 2 months of age) currently enrolled in Family Spirit. Precision Family Spirit participants receive core lessons plus additional lessons based on needs identified at baseline and that emerge during the trial. Control mothers receive the standard sequence of Family Spirit lessons. Data is collected at baseline (< 2 months postpartum), and 2, 6, and 12 months postpartum. All Precision Family Spirit participants are invited to complete qualitative interviews at study midpoint and endpoint. All home visitors are invited to participate in focus groups between study midpoint and endpoint. Exploratory data analysis will assess feasibility, acceptability, client-home visitor relationship, retention, adherence, and potential differences in intervention outcomes.DiscussionThis trial will provide new information about the acceptability and feasibility of precision home visiting and pilot data on program satisfaction, client-home visitor relationship, goal alliance, retention, and targeted maternal-child intervention outcomes. Findings will inform the design of a fully powered randomized implementation trial of precision vs. standard home visiting.Trial registrationClinicalTrials.gov # NCT03975530 ; Registered on June 5, 2019.

Dataset Information

An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial.

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An implementation-effectiveness hybrid trial of video-based family therapy for peripartum depression in home visited mothers: a protocol for a pilot trial.

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