scholarly journals Optimizing Social-Emotional-Communication Development in Infants of Mothers with Depression: A Randomized Controlled Trial Protocol of a Mobile Intervention Targeting Depression and Responsive Parenting (Preprint)

2021 ◽  
Author(s):  
Kathleen M. Baggett ◽  
Betsy Davis ◽  
Lisa Sheeber ◽  
Katy Miller ◽  
Craig Leve ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Maternal Depression ◽  
Controlled Trial ◽  
Mobile Internet ◽  
Depression Symptoms ◽  
Social Emotional ◽  
Communication Development ◽  
Randomized Controlled ◽  
Parent Practices

BACKGROUND Postpartum depression interferes with maternal engagement in interventions shown to be effective in improving infant social-emotional and communication outcomes. There is an absence of integrated interventions with demonstrated effectiveness in both reducing maternal depression and promoting parent-mediated practices that optimize infant social-emotional and communication competencies. Interventions targeting maternal depression are often separate from parent-mediated interventions. To address the life course needs of depressed mothers and their infants, we need brief, accessible, and integrated interventions that target both maternal depression and specific parent practices shown to improve infant social-emotional and communication trajectories. OBJECTIVE Evaluate the efficacy of a mobile internet intervention, Mom and Baby Net (MBN), with remote coaching to improve maternal mood and promote parent practices that optimize infant social-emotional and communication development. METHODS This is a 2-arm, randomized controlled, intent-to-treat trial. Primary outcomes include maternal depression symptoms and observed parent and infant behavior. Outcomes are measured via direct observational assessment and standardized questionnaires. The sample is being recruited within the urban core of a large southern city in the U.S. Study enrollment was initiated in 2017 and concluded in 2020. Participants are biological mothers with elevated depression symptoms, 18 years of age or older, who have custody of an infant less than 12 months of age. Exclusion criteria at the time of screening include maternal homelessness or shelter residence, inpatient mental health and/or substance abuse treatment, or maternal or infant treatment of a major mental or physical illness that would hinder meaningful study participation. RESULTS The start date of this grant-funded randomized controlled trial was September 1, 2016. Data collection is underway. Following IRB-approved pilot work, the randomized controlled trial was IRB- approved on November 17, 2017. Immediately following IRB approval, recruitment was initiated. Between February 15, 2018 and March 11, 2021, we successfully consented a sample of 184 women and their infants into the randomized controlled trial. The sample is predominantly African American and socioeconomically disadvantaged. CONCLUSIONS Data collection is scheduled to conclude in March 2022. We anticipate that relative to the attention control condition, which is focused on education around maternal depression and infant developmental milestones with matching technology and coaching structure, mothers in the MBN intervention will experience greater reductions in depression and gains in sensitive and responsive parent practices, and that their infants will demonstrate greater gains in social-emotional and communication behavior. CLINICALTRIAL Clinicaltrials.gov, identifier NCT03464630, https://clinicaltrials.gov/ct2/show/NCT03464630

Consistency of trajectories of suicidal ideation and depression symptoms: Evidence from a randomized controlled trial

2018 ◽  
Vol 36 (4) ◽  
pp. 321-329 ◽  
Author(s):  
Philip J. Batterham ◽  
Bregje A. J. Spijker ◽  
Andrew J. Mackinnon ◽  
Alison L. Calear ◽  
Quincy Wong ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Suicidal Ideation ◽  
Controlled Trial ◽  
Depression Symptoms ◽  
Randomized Controlled

scholarly journals The STress-And-coping suppoRT Intervention (START) for Chinese Women Undergoing Abortion: a Randomized Controlled Trial Protocol

2022 ◽  
Author(s):  
Na Wang ◽  
Jenny Gamble ◽  
Qiuxiang Zhang ◽  
Elizabeth Elder ◽  
Jyai Allen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Chinese Women ◽  
Research Training ◽  
Controlled Trial ◽  
Ethics Committees ◽  
Well Being ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Abortion Care ◽  
Research Training Program

Abstract Background:Undergoing an abortion is stressful. This protocol aims to assess the feasibility, acceptability, and primary effects of a complex intervention to promote positive coping behaviors and alleviating depression symptoms among Chinese women undergo abortion.Methods:A two-arm randomized controlled trial design will be used. Participants will be recruited at their first appointment with the abortion clinic, those who consent to participate will be randomly allocated to receive either the START intervention (in addition to standard abortion care) or standard care only. All participants will receive survey follow-up until six weeks post-abortion. Ethical has been granted by local and university ethics committees. This research was supported by an Australian Government Research Training Program (RTP) Scholarship Discussion:Results will assist refinement and further evaluations of the START intervention, contribute to improved abortion care practices in China, and enrich the literature evidence on improving women’s psychological well-being following abortion in ChinaTrial registration: Registered at the Chinese Clinical Trials.gov: ChiCTR2100046101. Date of registration: May 4, 2021

scholarly journals Group versus individual antenatal and first year postpartum care: Study protocol for a multi-country cluster randomized controlled trial in Kenya and Nigeria

2019 ◽  
Vol 2 ◽  
pp. 56 ◽  
Author(s):  
Mark M. Kabue ◽  
Lindsay Grenier ◽  
Stephanie Suhowatsky ◽  
Jaiyeola Oyetunji ◽  
Emmanuel Ugwa ◽  
...  
Keyword(s):  
Health Care ◽  
Randomized Controlled Trial ◽  
Data Collection ◽  
Pregnant Women ◽  
Controlled Trial ◽  
Phase 1 ◽  
First Year ◽  
Phase 2 ◽  
Randomized Controlled ◽  
Cluster Randomized

Background: Antenatal care (ANC) in many low- and middle-income countries is under-utilized and of sub-optimal quality. Group ANC (G-ANC) is an intervention designed to improve the experience and provision of ANC for groups of women (cohorts) at similar stages of pregnancy. Methods: A two-arm, two-phase, cluster randomized controlled trial (cRCT) (non-blinded) is being conducted in Kenya and Nigeria. Public health facilities were matched and randomized to either standard individual ANC (control) or G-ANC (intervention) prior to enrollment. Participants include pregnant women attending first ANC at gestational age <24 weeks, health care providers, and sub-national health managers. Enrollment ended in June 2017 for both countries. In the intervention arm, pregnant women are assigned to cohorts at first ANC visit and receive subsequent care together during five meetings facilitated by a health care provider (Phase 1). After birth, the same cohorts meet four times over 12 months with their babies (Phase 2). Data collection was performed through surveys, clinical data extraction, focus group discussions, and in-depth interviews. Phase 1 data collection ended in January 2018 and Phase 2 concludes in November 2018. Intention-to-treat analysis will be used to evaluate primary outcomes for Phases 1 and 2: health facility delivery and use of a modern method of family planning at 12 months postpartum, respectively. Data analysis and reporting of results will be consistent with norms for cRCTs. General estimating equation models that account for clustering will be employed for primary outcome analyzes. Results: Overall 1,075 and 1,013 pregnant women were enrolled in Nigeria and Kenya, respectively. Final study results will be available in February 2019. Conclusions: This is the first cRCT on G-ANC in Africa. It is among the first to examine the effects of continuing group care through the first year postpartum. Registration: Pan African Clinical Trials Registry PACTR201706002254227 May 02, 2017

scholarly journals Comparing a Mobile Phone Automated System With a Paper and Email Data Collection System: Substudy Within a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Diana M Bond ◽  
Jeremy Hammond ◽  
Antonia W Shand ◽  
Natasha Nassar
Keyword(s):  
Randomized Controlled Trial ◽  
Data Collection ◽  
Cost Analysis ◽  
Mobile Phone ◽  
Response Rate ◽  
Controlled Trial ◽  
Treatment Compliance ◽  
Automated System ◽  
Collection System ◽  
Randomized Controlled

BACKGROUND Traditional data collection methods using paper and email are increasingly being replaced by data collection using mobile phones, although there is limited evidence evaluating the impact of mobile phone technology as part of an automated research management system on data collection and health outcomes. OBJECTIVE The aim of this study is to compare a web-based mobile phone automated system (MPAS) with a more traditional delivery and data collection system combining paper and email data collection (PEDC) in a cohort of breastfeeding women. METHODS We conducted a substudy of a randomized controlled trial in Sydney, Australia, which included women with uncomplicated term births who intended to breastfeed. Women were recruited within 72 hours of giving birth. A quasi-randomized number of women were recruited using the PEDC system, and the remainder were recruited using the MPAS. The outcomes assessed included the effectiveness of data collection, impact on study outcomes, response rate, acceptability, and cost analysis between the MPAS and PEDC methods. RESULTS Women were recruited between April 2015 and December 2016. The analysis included 555 women: 471 using the MPAS and 84 using the PEDC. There were no differences in clinical outcomes between the 2 groups. At the end of the 8-week treatment phase, the MPAS group showed an increased response rate compared with the PEDC group (56% vs 37%; <i>P</i>&lt;.001), which was also seen at the 2-, 6-, and 12-month follow-ups. At the 2-month follow-up, the MPAS participants also showed an increased rate of self-reported treatment compliance (70% vs 56%; <i>P</i>&lt;.001) and a higher recommendation rate for future use (95% vs 64%; <i>P</i>&lt;.001) as compared with the PEDC group. The cost analysis between the 2 groups was comparable. CONCLUSIONS MPAS is an effective and acceptable method for improving the overall management, treatment compliance, and methodological quality of clinical research to ensure the validity and reliability of findings.

scholarly journals Preventing depression in final year secondary students: School-based randomized controlled trial

2020 ◽  
Author(s):  
Y Perry ◽  
A Werner-Seidler ◽  
A Calear ◽  
A Mackinnon ◽  
C King ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Secondary Students ◽  
Controlled Trial ◽  
School Level ◽  
Control Group ◽  
Depression Symptoms ◽  
Randomized Controlled ◽  
Control Intervention ◽  
The Impact

Background: Depression often emerges for the first time during adolescence. There is accumulating evidence that universal depression prevention programs may have the capacity to reduce the impact of depression when delivered in the school environment. Objective: This trial investigated the effectiveness of SPARX-R, a gamified online cognitive behavior therapy intervention for the prevention of depression relative to an attention-matched control intervention delivered to students prior to facing a significant stressor-final secondary school exams. It was hypothesized that delivering a prevention intervention in advance of a stressor would reduce depressive symptoms relative to the control group. Methods: A cluster randomized controlled trial was conducted in 10 government schools in Sydney, Australia. Participants were 540 final year secondary students (mean 16.7 [SD 0.51] years), and clusters at the school level were randomly allocated to SPARX-R or the control intervention. Interventions were delivered weekly in 7 modules, each taking approximately 20 to 30 minutes to complete. The primary outcome was symptoms of depression as measured by the Major Depression Inventory. Intention-to-treat analyses were performed. Results: Compared to controls, participants in the SPARX-R condition (n=242) showed significantly reduced depression symptoms relative to the control (n=298) at post-intervention (Cohen d=0.29) and 6 months post-baseline (d=0.21) but not at 18 months post-baseline (d=0.33). Conclusions: This is the first trial to demonstrate a preventive effect on depressive symptoms prior to a significant and universal stressor in adolescents. It demonstrates that an online intervention delivered in advance of a stressful experience can reduce the impact of such an event on the potential development or exacerbation of depression.

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