scholarly journals Exploring User-Centered Counseling and Male Involvement in Contraceptive Decision-Making: Protocol for a Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Mahesh Karra ◽  
Kexin Zhang
Keyword(s):  
Decision Making ◽  
Randomized Controlled Trial ◽  
Family Planning ◽  
Controlled Trial ◽  
Male Involvement ◽  
Contraceptive Methods ◽  
Randomized Controlled ◽  
Family Planning Counseling ◽  
User Centered

BACKGROUND As a means to achieve full, free, and informed choice within the frameworks of reproductive autonomy and women’s rights, family planning programs have increasingly begun to adopt user-centered approaches to counseling and service provision. These approaches have stressed the role of the individual client as the focal point of interaction and the key decision-maker. However, little is known about how user-centered approaches to family planning, particularly through the family planning counseling process, shape women’s and couple’s preferences and characterize their choices. OBJECTIVE We conduct a multi-armed randomized controlled trial that identifies the causal impact of user-centered counseling on women’s decision-making for family planning in urban Malawi. The causal effect of the interventions will be determined by comparing outcomes for respondents randomly assigned to three intervention arms (T1, T2, or T3) against outcomes from the control arm (T0). METHODS Married women aged 18-35 who were neither pregnant nor had given birth within the past 6 months were recruited and randomly assigned to one of the three intervention arms or a control arm characterized by two interventions: 1) an intervention that encouraged women to invite their husbands to family planning counseling; and 2) a tailored counseling session where women were counseled on a targeted range of 5 contraceptive methods based on women’s stated baseline preferences, in contrast to the standard range of 13 method that women were typically counseled on at public facilities. All women received a package of family planning services over a one-month period starting from the counseling day, which included: 1) free transportation to a clinic; and 2) financial reimbursement for family-planning-related services. Follow-up surveys were conducted with women either at the clinic or by phone/through home visits with those who did not visit the clinic over the service period. RESULTS A total of 785 women completed the baseline survey and 782 eligible respondents were randomized to one of the three intervention groups or a control group (T1: 223, T2: 225, T3: 228, and T0: 108). From November 2019 to February 2020, a total of 767 women were reached for follow-up surveys. Among these 767 reached women, 731 completed the follow-up survey, among which 435 were reached by phone, 254 received home surveys, and 67 women were followed up at the clinic. CONCLUSIONS Results from this trial seek to fill the current knowledge gaps on the effectiveness of: 1) tailored family planning counseling, and 2) male involvement in family planning, on women’s stated and realized contraceptive preferences. More generally, the study findings provide evidence that user-centered counseling could improve women’s willingness to use and continue contraceptive methods, facilitate realization of contraceptive preferences, and improve women’s well-being. CLINICALTRIAL This trial was registered at the American Economics Association Registry for randomized controlled trials (https://www.socialscienceregistry.org) on May 20, 2019 (AEARCTR-0004194) and at the Registry for International Development Impact Evaluations (RIDIE, ridie.3ieimpact.org/) on May 22, 2019 (RIDIE-STUDY-ID-5ce4f42bbc2bf).

scholarly journals The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial (Preprint)

2019 ◽  
Author(s):  
Mahesh Karra ◽  
David Canning
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Data Collection ◽  
Contraceptive Use ◽  
Controlled Trial ◽  
Well Being ◽  
Birth Spacing ◽  
Randomized Controlled ◽  
Causal Impact

BACKGROUND The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. OBJECTIVE This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. METHODS Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. RESULTS A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. CONCLUSIONS The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. CLINICALTRIAL American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/16697

scholarly journals The Effect of Improved Access to Family Planning on Postpartum Women: Protocol for a Randomized Controlled Trial

10.2196/16697 ◽  
2020 ◽  
Vol 9 (8) ◽  
pp. e16697
Author(s):  
Mahesh Karra ◽  
David Canning
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Data Collection ◽  
Contraceptive Use ◽  
Controlled Trial ◽  
Well Being ◽  
Birth Spacing ◽  
Randomized Controlled ◽  
Causal Impact

Background The World Health Organization recommends that a woman waits at least 24 months after a live birth before getting pregnant again; however, an estimated 25% of birth intervals in low-income countries do not meet this recommendation for adequate birth spacing, and the unmet need for postpartum family planning (PPFP) services is high. Few randomized controlled trials have assessed the causal impact of access to PPFP services, and even fewer evaluations have investigated how such interventions may affect postpartum contraceptive use, birth spacing, and measures of health and well-being. Objective This protocol paper aims to describe a randomized controlled trial that is being conducted to identify the causal impact of an intervention to improve access to PPFP services on contraceptive use, pregnancy, and birth spacing in urban Malawi. The causal effect of the intervention will be determined by comparing outcomes for respondents who are randomly assigned to an intervention arm against outcomes for respondents who are randomly assigned to a control arm. Methods Married women aged 18-35 years who were either pregnant or had recently given birth were randomly assigned to either the intervention arm or control arm. Women assigned to the intervention arm received a package of services over a 2-year intervention period. Services included a brochure and up to 6 home visits from trained family planning counselors; free transportation to a high-quality family planning clinic; and financial reimbursement for family planning services, consultations, and referrals for services. Two follow-up surveys were conducted 1 and 2 years after the baseline survey. Results A total of 2143 women were randomly assigned to either the intervention arm (n=1026) or the control arm (n=1117). Data collection for the first follow-up survey began in August 2017 and was completed in February 2018. A total of 1773 women, or 82.73% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the first follow-up. Data collection for the second follow-up survey began in August 2018 and was completed in February 2019. A total of 1669 women, or 77.88% of women who were eligible for follow-up, were successfully contacted and reinterviewed at the second follow-up. The analysis of the primary outcomes is ongoing and is expected to be completed in 2021. Conclusions The results of this trial seek to fill the current knowledge gaps in the effectiveness of family planning interventions on improving fertility and health outcomes. The findings also show that the benefits of improving access to family planning are likely to extend beyond the fertility and health domain by improving other measures of women’s well-being. Trial Registration American Economics Association Registry Trial Number AEARCTR-0000697; https://www.socialscienceregistry.org/trials/697 Registry for International Development Impact Evaluations (RIDIE) Trial Number RIDIE-STUDY-ID-556784ed86956; https://ridie.3ieimpact.org/index.php?r=search/detailView&id=320 International Registered Report Identifier (IRRID) DERR1-10.2196/16697

scholarly journals Feasibility and Acceptability of a Digital Intervention to Support Shared Decision-making in Children’s and Young People’s Mental Health: Mixed Methods Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Shaun Liverpool ◽  
Julian Edbrooke-Childs
Keyword(s):  
Mental Health ◽  
Health Care ◽  
Decision Making ◽  
Randomized Controlled Trial ◽  
Shared Decision Making ◽  
Controlled Trial ◽  
Feasibility Trial ◽  
Shared Decision ◽  
Randomized Controlled

BACKGROUND Interventions to involve parents in decisions regarding children’s and young people’s mental health are associated with positive outcomes. However, appropriately planning effectiveness studies is critical to ensure that meaningful evidence is collected. It is important to conduct pilot studies to evaluate the feasibility and acceptability of the intervention itself and the feasibility of the protocol to test effectiveness. OBJECTIVE This paper reports the findings from a feasibility and acceptability study of Power Up for Parents, an intervention to promote shared decision-making (SDM) and support parents and caregivers making decisions regarding children’s and young people’s mental health. METHODS A mixed method study design was adopted. In stage 1, health care professionals and parents provided feedback on acceptability, usefulness, and suggestions for further development. Stage 2 was a multicenter, 3-arm, individual, and cluster randomized controlled pilot feasibility trial with parents accessing services related to children’s and young people’s mental health. Outcome measures collected data on demographics, participation rates, SDM, satisfaction, and parents’ anxiety. Qualitative data were analyzed using thematic analysis. Google Analytics estimates were used to report engagement with the prototype. Outcomes from both stages were tested against a published set of criteria for proceeding to a randomized controlled trial. RESULTS Despite evidence suggesting the acceptability of Power Up for Parents, the findings suggest that recruitment modifications are needed to enhance the feasibility of collecting follow-up data before scaling up to a fully powered randomized controlled trial. On the basis of the Go or No-Go criteria, only 50% (6/12) of the sites successfully recruited participants, and only 38% (16/42) of parents completed follow-up measures. Nonetheless, health care practitioners and parents generally accessed and used the intervention. Themes describing <i>appearance and functionality, perceived need and general helpfulness, accessibility and appropriateness,</i> and <i>a wish list for improvement</i> emerged, providing valuable information to inform future development and refinement of the intervention. CONCLUSIONS Owing to the high attrition observed in the trial, proceeding directly to a full randomized controlled trial may not be feasible with this recruitment strategy. Nonetheless, with some minor adjustments and upgrades to the intervention, this pilot study provides a platform for future evaluations of Power Up for Parents. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 39238984; http://www.isrctn.com/ISRCTN39238984. INTERNATIONAL REGISTERED REPORT RR2-10.2196/14571

scholarly journals The role of behavior change communication on knowledge and uptake of postpartum contraception among antenatal mothers in Puducherry: a randomized controlled trial

2020 ◽  
Vol 9 (5) ◽  
pp. 2024
Author(s):  
Neelima S. Chauhan ◽  
Agnes Mathew
Keyword(s):  
Randomized Controlled Trial ◽  
Family Planning ◽  
Controlled Trial ◽  
Intervention Group ◽  
Communication Strategy ◽  
Family Welfare ◽  
Contraceptive Methods ◽  
Postpartum Contraception ◽  
Randomized Controlled ◽  
Change Communication

Background: India accounts for world's 17.5 percent population and is the second most populous country in the world next only to China (19.4%). Birth control pills, condoms, sterilization, IUD (intrauterine device) etc. are most commonly practiced family planning methods in India. The latest NFHS shows that 77% of sterilized women did not use a family planning method. Despite of family welfare program having a target free approach, the program has not been successful in educating people about the concept and advantages of contraceptive methods for spacing births.Methods: This randomized controlled trial was carried out in the department of obstetrics and gynecology of Pondicherry Institute of Medical Sciences (PIMS), Puducherry. All antenatal mothers >28 weeks of gestational age were enrolled and given a semi-structured questionnaire. After randomization intervention was done in the form of counselling and distribution of pamphlets for future use. The women were followed in the postnatal period and 6 weeks later.Results: A total of 280 subjects were enrolled in this study. Socio-demographic characteristics were similar in both the study groups. Majority of women in both the comparison and intervention group were in the age group 20-25 years (43.6%). Very few participants (20.0%) had used some form of contraception to delay pregnancy. However, the postpartum follow-up of the study participants revealed significant increase in the knowledge on the various contraceptive methods in the intervention group compared with the comparison group.Conclusions: The implementation of behaviour change communication strategy to communicate the benefits of uptake of postpartum contraception to antenatal mothers, is vital in improving the acceptability of family planning programs in India.

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