scholarly journals Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial

10.2196/27138 ◽  
2021 ◽  
Vol 10 (3) ◽  
pp. e27138
Author(s):  
Justine Dol ◽  
Megan Aston ◽  
Douglas McMillan ◽  
Gail Tomblin Murphy ◽  
Marsha Campbell-Yeo
Keyword(s):  
Social Support ◽  
Randomized Controlled Trial ◽  
Postpartum Depression ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Text Message ◽  
Psychosocial Outcomes ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

Background Women experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum. Objective The primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program. Methods This will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant’s age and the woman’s self-selected preference for breastfeeding or formula feeding and tailored with the infant’s name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant’s date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention. Results Recruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022. Conclusions This study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program. Trial Registration ClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570 International Registered Report Identifier (IRRID) DERR1-10.2196/27138

scholarly journals Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Justine Dol ◽  
Megan Aston ◽  
Douglas McMillan ◽  
Gail Tomblin Murphy ◽  
Marsha Campbell-Yeo
Keyword(s):  
Social Support ◽  
Randomized Controlled Trial ◽  
Postpartum Depression ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Text Message ◽  
Psychosocial Outcomes ◽  
Control Group ◽  
Depression And Anxiety ◽  
Randomized Controlled

BACKGROUND Women experience changes both physically and psychologically during their transition to motherhood. The postnatal period is a critical time for women to develop maternal self-efficacy. Mobile health interventions may offer a way to reach women during this critical period to offer support and information. Essential Coaching for Every Mother is a text message program that seeks to educate and support women during the first 6 weeks postpartum. OBJECTIVE The primary effectiveness objective is to compare the effectiveness of the Essential Coaching for Every Mother program on maternal psychosocial outcomes (self-efficacy, social support, postpartum depression, and postpartum anxiety) immediately after the intervention and 6 months postpartum, collectively as well as stratified by parity. The primary implementation objective is to evaluate the implementation extent and quality of the Essential Coaching for Every Mother program. METHODS This will be a hybrid type 1 effectiveness-implementation randomized controlled trial. A total of 140 mothers-to-be or new mothers from Nova Scotia will be recruited and randomized to the intervention or control arm, stratified by parity. The intervention arm will receive the Essential Coaching for Every Mother program, which consists of 53 messages sent twice a day for the first 2 weeks and daily for weeks 3 through 6. The control group will receive usual care. Messages are personalized based on the infant’s age and the woman’s self-selected preference for breastfeeding or formula feeding and tailored with the infant’s name and gender. Women can enroll in the program if they are ≥37 weeks pregnant or within 10 days postpartum, with the first message designed to be sent on the second evening after birth. The actual number of messages received will vary based on the timing of enrollment and the infant’s date of birth. Participants will complete questionnaires assessing self-efficacy, social support, and postpartum depression and anxiety at baseline (enrollment after birth) and 6 weeks (postintervention) and 6 months postpartum. Implementation data will be collected throughout the trial, and evaluation feedback will be collected at 6 weeks from women who received the intervention. RESULTS Recruitment for this study started on January 5, 2021, and is currently ongoing, with an anticipated date of recruitment completion of January 2022. CONCLUSIONS This study will assess the effectiveness of a postpartum text message program to improve maternal self-efficacy and social support while decreasing postpartum depression and anxiety. It will also shed light on the implementation effectiveness of the program. CLINICALTRIAL ClinicalTrials.gov NCT04730570; https://clinicaltrials.gov/ct2/show/NCT04730570 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/27138

scholarly journals Effectiveness of a Technology-Based Supportive Educational Parenting Program on Parental Outcomes in Singapore: Protocol for a Randomized Controlled Trial (Preprint)

2017 ◽  
Author(s):  
Shefaly Shorey ◽  
Yvonne Peng Mei Ng ◽  
An Ling Siew ◽  
Joanne Yoong ◽  
Evalotte M�relius
Keyword(s):  
Social Support ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Transition To Parenthood ◽  
Controlled Trial ◽  
Well Being ◽  
Perinatal Period ◽  
Educational Programs ◽  
Parenting Program ◽  
Randomized Controlled

BACKGROUND Supportive educational programs during the perinatal period are scarce in Singapore. There is no continuity of care available in terms of support from community care nurses in Singapore. Parents are left on their own most of the time, which results in a stressful transition to parenthood. There is a need for easily accessible technology-based educational programs that can support parents during this crucial perinatal period. OBJECTIVE The aim of this study was to describe the study protocol of a randomized controlled trial on a technology-based supportive educational parenting program. METHODS A randomized controlled two-group pretest and repeated posttest experimental design will be used. The study will recruit 118 parents (59 couples) from the antenatal clinics of a tertiary public hospital in Singapore. Eligible parents will be randomly allocated to receive either the supportive educational parenting program or routine perinatal care from the hospital. Outcome measures include parenting self-efficacy, parental bonding, postnatal depression, social support, parenting satisfaction, and cost evaluation. Data will be collected at the antenatal period, immediate postnatal period, and at 1 month and 3 months post childbirth. RESULTS Recruitment of the study participants commenced in December 2016 and is still ongoing. Data collection is projected to finish within 12 months, by December 2017. CONCLUSIONS This study will identify a potentially clinically useful, effective, and cost-effective supportive educational parenting program to improve parental self-efficacy and bonding in newborn care, which will then improve parents’ social support–seeking behaviors, emotional well-being, and satisfaction with parenting. It is hoped that better supported and satisfied parents will consider having more children, which may in turn influence Singapore’s ailing birth rate. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN): 48536064; https://www.isrctn.com/ISRCTN48536064 (Archived by WebCite at http://www.webcitation.org/6wMuEysiO)

Randomized Controlled Trial of Mindfulness-Based Cancer Recovery Versus Supportive Expressive Group Therapy for Distressed Survivors of Breast Cancer (MINDSET)

2013 ◽  
Vol 31 (25) ◽  
pp. 3119-3126 ◽  
Author(s):  
Linda E. Carlson ◽  
Richard Doll ◽  
Joanne Stephen ◽  
Peter Faris ◽  
Rie Tamagawa ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Quality Of Life ◽  
Social Support ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Stress Symptoms ◽  
Over Time

Purpose To compare the efficacy of the following two empirically supported group interventions to help distressed survivors of breast cancer cope: mindfulness-based cancer recovery (MBCR) and supportive-expressive group therapy (SET). Patients and Methods This multisite, randomized controlled trial assigned 271 distressed survivors of stage I to III breast cancer to MBCR, SET, or a 1-day stress management control condition. MBCR focused on training in mindfulness meditation and gentle yoga, whereas SET focused on emotional expression and group support. Both intervention groups included 18 hours of professional contact. Measures were collected at baseline and after intervention by assessors blind to study condition. Primary outcome measures were mood and diurnal salivary cortisol slopes. Secondary outcomes were stress symptoms, quality of life, and social support. Results Using linear mixed-effects models, in intent-to-treat analyses, cortisol slopes were maintained over time in both SET (P = .002) and MBCR (P = .011) groups relative to the control group, whose cortisol slopes became flatter. Women in MBCR improved more over time on stress symptoms compared with women in both the SET (P = .009) and control (P = .024) groups. Per-protocol analyses showed greater improvements in the MBCR group in quality of life compared with the control group (P = .005) and in social support compared with the SET group (P = .012). Conclusion In the largest trial to date, MBCR was superior for improving stress levels, quality of life, and social support for distressed survivors of breast cancer. Both SET and MBCR also resulted in more normative diurnal cortisol profiles than the control condition. The clinical implications of this finding require further investigation.

scholarly journals A 12-Week Electronic Mentoring Employment Preparation Intervention for Youth With Physical Disabilities: Pilot Feasibility Randomized Controlled Trial (Preprint)

2018 ◽  
Author(s):  
Sally Lindsay ◽  
Elaine Cagliostro ◽  
Joanne Leck ◽  
Jennifer Stinson
Keyword(s):  
Social Support ◽  
Randomized Controlled Trial ◽  
Physical Disabilities ◽  
Controlled Trial ◽  
Intervention Group ◽  
Self Determination ◽  
Control Group ◽  
Electronic Mentoring ◽  
Youth With Disabilities ◽  
Randomized Controlled

BACKGROUND Youth with disabilities are at high risk of unemployment compared with youth without disabilities. They often encounter challenges in accessing vocational programs that meet their needs. One promising approach that could help to address barriers that youth encounter while also enhancing social support is through electronic mentoring (e-mentoring). Although there is an increase in e-mentoring for youth with disabilities, little is known about its impact for youth with physical disabilities. OBJECTIVE This study aimed to assess the acceptability and initial impact of a Web-based peer electronic mentor employment intervention for youth with physical disabilities. METHODS The Empowering Youth Towards Employment intervention was evaluated using a pilot randomized controlled trial (RCT). Youth, aged 15-21 years, with physical disabilities were randomly assigned to an intervention (ie, mentored) or control (ie, not mentored) group. Trained mentors (ie, near peers) with a physical disability led the online discussion forums and provided peer support and resources for 12 modules (1 topic per week over 12 weeks). Primary outcomes focused on self-determination, career maturity, and social support. We also explored program adherence and dosage, participant satisfaction, and areas for improvement. RESULTS A total of 13 youth (mean age 17.3 years, SD 1.88; 54%, 7/13 female) completed the RCT. In the intervention group (n=9), 56% (5/9) of the youth were females, and in the control group (n=4), 50% (2/4) of the youth were female. Participants reported satisfaction with the program and that it was feasible and acceptable. Participants’ mean engagement level with the program was 5.22 (SD 2.48) for the intervention group and 5.40 (SD 4.56) for controls. Participants in the intervention group demonstrated significant improvements in self-determination (t12=2.49; P<.04) compared with the control group. No adverse events were reported. CONCLUSIONS The Empowering Youth Towards Employment is a promising intervention that enhances self-determination among youth with physical disabilities. CLINICALTRIAL ClinicalTrials.gov NCT02522507; https://clinicaltrials.gov/ct2/show/NCT02522507 (Archived by WebCite at http://www.webcitation.org/6uD58Pvjc)

scholarly journals A comparison of patient, intervention, comparison, outcome (PICO) to a new, alternative clinical question framework for search skills, search results, and self-efficacy: a randomized controlled trial

2020 ◽  
Vol 108 (2) ◽  
Author(s):  
Lorie A. Kloda ◽  
Jill T. Boruff ◽  
Alexandre Soares Cavalcante
Keyword(s):  
Randomized Controlled Trial ◽  
Information Literacy ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Clinical Question ◽  
Alternative Framework ◽  
Randomized Controlled ◽  
Clinical Questions ◽  
Experimental Group

Objective: In educating students in the health professions about evidence-based practice, instructors and librarians typically use the patient, intervention, comparison, outcome (PICO) framework for asking clinical questions. A recent study proposed an alternative framework for the rehabilitation professions. The present study investigated the effectiveness of teaching the alternative framework in an educational setting.Methods: A randomized controlled trial was conducted with students in occupational therapy (OT) and physical therapy (PT) to determine if the alternative framework for asking clinical questions was effective for identifying information needs and searching the literature. Participants were randomly allocated to a control or experimental group to receive ninety minutes of information literacy instruction from a librarian about formulating clinical questions and searching the literature using MEDLINE. The control group received instruction that included the PICO question framework, and the experimental group received instruction that included the alternative framework.Results: There were no significant differences in search performance or search skills (strategy and clinical question formulation) between the two groups. Both the control and experimental groups demonstrated a modest but significant increase in information literacy self-efficacy after the instruction; however, there was no difference between the two groups.Conclusion: When taught in an information literacy session, the new, alternative framework is as effective as PICO when assessing OT and PT students’ searching skills. Librarian-led workshops using either question formulation framework led to an increase in information literacy self-efficacy post-instruction.

scholarly journals Effects of an attachment-based parent intervention on mothers of children with autism spectrum disorder: preliminary findings from a non-randomized controlled trial

2021 ◽  
Vol 15 (1) ◽  
Author(s):  
Nobuyo Kubo ◽  
Megumi Kitagawa ◽  
Sayaka Iwamoto ◽  
Toshifumi Kishimoto
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Intervention Group ◽  
Children With Autism ◽  
Autism Spectrum ◽  
Control Group ◽  
Randomized Controlled ◽  
Children With Asd

Abstract Background Caregivers of children with autism spectrum disorders (ASD) often experience difficulties in responding appropriately to the needs of those children, who typically express attachment in distinct and nonconventional ways. This highlights the need for an attachment-based approach targeted at caregivers of children with ASD. Circle of Security Parenting (COSP), an attachment-based parenting program, is designed to increase caregivers’ sensitivity to children’s attachment needs. The aim of this study was to provide verification of the effectiveness of COSP in mothers of children with ASD. Methods This study was a non-randomized controlled trial. Sixty mothers of children with ASD aged 4–12 were recruited. Twenty mothers received the COSP intervention, while 40 did not. The characteristics of children in the control group were matched with those of the intervention group. To evaluate the outcomes of the intervention, changes in parental self-efficacy and mental health were assessed using the Tool to Measure Parenting Self-Efficacy (TOPSE) and the General Health Questionnaire-30 (GHQ-30). The children’s improvement in emotional and behavioral problems was assessed from the mothers’ perspective using the Child Behavior Checklist (CBCL). Both groups completed the assessments in parallel. Evaluations were compared between baseline (T1) and 6-month follow-up (T2). Results Scores for self-efficacy and mental health of mothers and behavior of children were significantly improved from T1 to T2 in the intervention group, but not in the control group. Participants’ mental health was markedly worsened in the control group. Conclusion This study demonstrated that the COSP program for mothers of children with ASD improved their parental self-efficacy and mental health, and reduced their subjective sense of difficulties related to their children’s behaviors. Our findings support the effectiveness of the attachment-based program for mothers of children with ASD, providing the groundwork for further studies of the attachment-based intervention for children with ASD and their families. Future studies with larger samples and randomization are also needed for direct evaluation of the improvement of children's attachment security, and for exploration of the synergistic relationship between various family support strategies and COSP. Trial Registration This trial was registered with the University Hospital Medical Information Network Clinical Trial Registry (No. UMIN000039574)

scholarly journals Efficacy of an Internet-based, individually tailored smoking cessation program: A randomized-controlled trial

2016 ◽  
Vol 23 (5) ◽  
pp. 521-528 ◽  
Author(s):  
Céline Mavrot ◽  
Iris Stucki ◽  
Fritz Sager ◽  
Jean-François Etter
Keyword(s):  
Randomized Controlled Trial ◽  
Smoking Cessation ◽  
Self Efficacy ◽  
Controlled Trial ◽  
Control Group ◽  
Randomized Controlled ◽  
Motivation To Quit ◽  
Computer Based ◽  
E Mail ◽  
Tailored Program

Introduction Self-help computer-based programs are easily accessible and cost-effective interventions with a great recruitment potential. However, each program is different and results of meta-analyses may not apply to each new program; therefore, evaluations of new programs are warranted. The aim of this study was to assess the marginal efficacy of a computer-based, individually tailored program (the Coach) over and above the use of a comprehensive Internet smoking cessation website. Methods A two-group randomized controlled trial was conducted. The control group only accessed the website, whereas the intervention group received the Coach in addition. Follow-up was conducted by e-mail after three and six months (self-administrated questionnaires). Of 1120 participants, 579 (51.7%) responded after three months and 436 (38.9%) after six months. The primary outcome was self-reported smoking abstinence over four weeks. Results Counting dropouts as smokers, there were no statistically significant differences between intervention and control groups in smoking cessation rates after three months (20.2% vs. 17.5%, p = 0.25, odds ratio (OR) = 1.20) and six months (17% vs. 15.5%, p = 0.52, OR = 1.12). Excluding dropouts from the analysis, there were statistically significant differences after three months (42% vs. 31.6%, p = 0.01, OR = 1.57), but not after six months (46.1% vs. 37.8%, p = 0.081, OR = 1.41). The program also significantly increased motivation to quit after three months and self-efficacy after three and six months. Discussion An individually tailored program delivered via the Internet and by e-mail in addition to a smoking cessation website did not significantly increase smoking cessation rates, but it increased motivation to quit and self-efficacy.

scholarly journals Using Psychological Artificial Intelligence (Tess) to Relieve Symptoms of Depression and Anxiety: Randomized Controlled Trial

2018 ◽  
Vol 5 (4) ◽  
pp. e64 ◽  
Author(s):  
Russell Fulmer ◽  
Angela Joerin ◽  
Breanna Gentile ◽  
Lysanne Lakerink ◽  
Michiel Rauws
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Cost Effective ◽  
Control Group ◽  
Depression And Anxiety ◽  
Symptoms Of Depression ◽  
Randomized Controlled ◽  
Significant Difference ◽  
Unlimited Access ◽  
Group 1

Background Students in need of mental health care face many barriers including cost, location, availability, and stigma. Studies show that computer-assisted therapy and 1 conversational chatbot delivering cognitive behavioral therapy (CBT) offer a less-intensive and more cost-effective alternative for treating depression and anxiety. Although CBT is one of the most effective treatment methods, applying an integrative approach has been linked to equally effective posttreatment improvement. Integrative psychological artificial intelligence (AI) offers a scalable solution as the demand for affordable, convenient, lasting, and secure support grows. Objective This study aimed to assess the feasibility and efficacy of using an integrative psychological AI, Tess, to reduce self-identified symptoms of depression and anxiety in college students. Methods In this randomized controlled trial, 75 participants were recruited from 15 universities across the United States. All participants completed Web-based surveys, including the Patient Health Questionnaire (PHQ-9), Generalized Anxiety Disorder Scale (GAD-7), and Positive and Negative Affect Scale (PANAS) at baseline and 2 to 4 weeks later (T2). The 2 test groups consisted of 50 participants in total and were randomized to receive unlimited access to Tess for either 2 weeks (n=24) or 4 weeks (n=26). The information-only control group participants (n=24) received an electronic link to the National Institute of Mental Health’s (NIMH) eBook on depression among college students and were only granted access to Tess after completion of the study. Results A sample of 74 participants completed this study with 0% attrition from the test group and less than 1% attrition from the control group (1/24). The average age of participants was 22.9 years, with 70% of participants being female (52/74), mostly Asian (37/74, 51%), and white (32/74, 41%). Group 1 received unlimited access to Tess, with daily check-ins for 2 weeks. Group 2 received unlimited access to Tess with biweekly check-ins for 4 weeks. The information-only control group was provided with an electronic link to the NIMH’s eBook. Multivariate analysis of covariance was conducted. We used an alpha level of .05 for all statistical tests. Results revealed a statistically significant difference between the control group and group 1, such that group 1 reported a significant reduction in symptoms of depression as measured by the PHQ-9 (P=.03), whereas those in the control group did not. A statistically significant difference was found between the control group and both test groups 1 and 2 for symptoms of anxiety as measured by the GAD-7. Group 1 (P=.045) and group 2 (P=.02) reported a significant reduction in symptoms of anxiety, whereas the control group did not. A statistically significant difference was found on the PANAS between the control group and group 1 (P=.03) and suggests that Tess did impact scores. Conclusions This study offers evidence that AI can serve as a cost-effective and accessible therapeutic agent. Although not designed to appropriate the role of a trained therapist, integrative psychological AI emerges as a feasible option for delivering support. Trial Registration International Standard Randomized Controlled Trial Number: ISRCTN61214172; https://doi.org/10.1186/ISRCTN61214172.

The effectiveness of a web-based psycho-education program in a community in Selangor, Malaysia: A randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Sherina Mohd-Sidik ◽  
Siti Fatimah Kader Maideen ◽  
Lekhraj Rampal ◽  
Firdaus Mukhtar
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Health Literacy ◽  
Mental Health Literacy ◽  
Controlled Trial ◽  
Control Group ◽  
Depression And Anxiety ◽  
Web Based ◽  
Randomized Controlled ◽  
Significant Difference

BACKGROUND Background Mental health problems namely depression and anxiety are the most common problems in the community. Often patients do not seek professional care due to the stigma attached to it. OBJECTIVE The study aimed to determine the effectiveness of a web-based psycho-education program in managing mild depression and anxiety. Methods METHODS A two-arm randomized controlled trial of a single blinded, parallel study comparing a four weeks of web-based psycho-education intervention program versus a wait list control group was carried out. The intervention program consisted of four sessions, with each session accessed on a weekly basis. Participants aged 18 years and above, who have participated in the first phase of this study, having access to internet and who are internet literate were invited to participate in the study. By using a random number table, 119 eligible and consented participants were randomly assigned to either the intervention or the control group using random number table. The primary outcomes were depression and anxiety score while the secondary outcome was mental health literacy score, which were all assessed at baseline, week 5 and week 12. Analysis was based on intention to treat analysis. RESULTS Significant difference in the mental health literacy score between the intervention and the control group was observed, F (1,117) = 20.149, p<0.001, n2=0.142. No significant difference was found in the depression (p= 0.361) and anxiety scores (p= 0.797). CONCLUSIONS The psycho-education intervention was effective in increasing the mental health literacy of the participants. CLINICALTRIAL The trial is registered in International Standard Randomized Controlled Trial, ISRCTN 39656144.

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