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Evaluation of Tipping Point

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ClinicalTrials.gov Identifier: NCT03965273
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : June 28, 2019
Sponsor:
Collaborators:
CARE Bangladesh
Gram Bikash Kendra (GBK)
CARE USA
Information provided by (Responsible Party):
International Centre for Diarrhoeal Disease Research, Bangladesh

Brief Summary:
This study evaluates whether an intervention, namely Tipping Point (TP), can reduce child marriage and increase decision making capability among the adolescent girls in rural areas. This is a cluster randomized controlled trial with three intervention arms - full TP package, light TP package (differs from the full TP only in terms of the intensity of the social norms change component) and control. The study is being conducted in Pirgacha sub district of Rangpur district in Bangladesh. A 18-month intervention will be in place after completion of the baseline survey and the endline survey will be conducted 18 months after the intervention completion. This design will allow the investigators to measure the impact of full TP intervention, light TP intervention and the emphasized social norms change.

Condition or disease Intervention/treatment Phase
Child Marriage Behavioral: Full TP Behavioral: Light TP Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2699 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:

The trial employs a three arm Cluster Randomized Controlled Trial (CRCT) design and uses both quantitative and qualitative methods for evaluating TP. The arms are as follows:

Arm 1: Full TP intervention including emphasized social norms change Arm 2: Light TP intervention without emphasized social norms change Arm 3: Pure control

This 3-arm design will enable us to measure the effect of the light TP intervention as well as the effect of social norms change on TP outcomes. The effects will be determined by comparing the three arms as follows:

Arm 1 - Arm 3 = Effect of full TP intervention Arm 2 - Arm 3 = Effect of light TP intervention Arm 1 - Arm 2 = Effect of emphasized social norms change

TP will be implemented in one upazila (sub-district) of Rangpur district. Rangpur has been selected as the median age at marriage is 15 years among women aged 20-49, which is the lowest in the country.

Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Cluster Randomized Controlled Trial for Measuring the Impact of Tipping Point - an Intervention Addressing Child Marriage in Selected District of Bangladesh
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: Full TP
Full TP intervention including emphasized social norms change
Behavioral: Full TP
The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Community and Social Norms Change Component; iv) Facilitated sessions with mothers' groups and (separate) fathers' groups; v) 2-days intensive facilitated workshop with selected religious leaders and influential people; vi) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vii) Trainings of girls, boys and parents with special interest in activism.

Experimental: Light TP
Light TP intervention without emphasized social norms change
Behavioral: Light TP
The overall Tipping Point intervention package will span 18 months and will involve: i) Weekly facilitated training sessions with girls' groups and boys' groups; ii) Dialogue sessions jointly with girls' groups and fathers' groups, and girls' groups and boys' groups; iii) Facilitated sessions with mothers' groups and (separate) fathers' groups; iv) 2-days intensive facilitated workshop with selected religious leaders and influential people; v) Village savings and loans associations (VSLAs) formed by the girls' group members to create opportunities for girls to engage in age-appropriate income generating activities and build their potential as entrepreneurs; vi) Trainings of girls, boys and parents with special interest in activism.

No Intervention: Pure control
Pure control



Primary Outcome Measures :
  1. Child marriage [ Time Frame: 36 months ]
    Rate of child marriage will be measured by collecting information on age at marriage for each of the married household members during the enumeration of households. Information will be collected for each of the present members of the households as well as for members that were married of to another family during the last one year.

  2. Decision making ability of adolescent girls [ Time Frame: 36 months ]
    Decision making will be measured by asking few questions around decision making regarding education, marriage, mobility, participation in financial activities.


Secondary Outcome Measures :
  1. Attitudes towards gender and rights [ Time Frame: 36 months ]
    Attitudes towards gender and rights will be measured using modified version of the the Gender-Equitable Men (GEM) Scale (Pulerwitz & Barker, 2007). This tool was adapted and validated for early adolescent males in India (Das, 2014) with high validity, Cronbach's alpha =0.83. There are 25 statements around gender norms and roles. Opinions will be sought about these statements using a 4-point likert-scale. The response options include: (1) strongly agree, (2) agree, (3) disagree, and (4) strongly disagree. Based on the experience of pre-testing, cognitive testing and piloting for adolescent girls there will be two response options i.e. (1) agree and (2) disagree, however for the community survey we will use 4-point likert-scale. The tool will be validated.

  2. Aspiration and choices of adolescent of adolescent girls [ Time Frame: 36 months ]
    Aspiration and choices of adolescents around education, occupation and marriage will be asked. A few questions will be framed to gain an insight about her desire on the issues.

  3. Communication and negotiation skill of adolescent girls [ Time Frame: 36 months ]
    An adapted version of the interpersonal communication inventory will be used to measure communication and negotiation skills of the girls. The scale was developed and validated by Bienvenn (1971, 1976). The inventory has 40 items. Example of typical items include - "Do your words come out the way you would like them to in the conversation?"; "Is it difficult for you to talk with other people?". The responses will be recorded as "agree"; and "disagree". The tool has been used in different populations (Huang, 2015; Cromwell, 2004). The tool will be validated for using data reduction technique.

  4. Adolescent Sexual and Reproductive Health and Rights (ASRHR) [ Time Frame: 36 months ]
    Questions will be added to capture adolescent girls' and boys' knowledge, attitudes and practices around sexual and reproductive health. Information will be collected around menstruation, reproductive and sexual health, family planning, services around SRHR etc. The questions will heavily draw upon the illustrative questionnaire for survey with young people (Cleland, n.d) and SAFE questionnaire (Naved & Amin, 2012).

  5. Social norms related to child marriage [ Time Frame: 36 months ]
    Social norms around child marriage will be measured following the empirical research by Cialdini (1998) and Bicchieri (2006, 2012) that shows the important distinction between a descriptive norm (doing what others do) and an injunctive norm (doing what others think one should do). The statements to capture social norms around child marriage were framed considering this theory. The examples of typical statements are: "Most people in my village will approve if a girl expresses her opinion regarding her marriage to her parents"; "Most people in our village expect a girl to marry before the age of 18" (injunctive norms). Response options will be captured in 3-point Likert-scale. The response options include: (1) approve, (2) disapprove, and (3) neutral.

  6. Group cohesion, solidarity and mobilization skills of adolescent girls [ Time Frame: 36 months ]
    The neighbourhood cohesion scale will be adapted and modified for measuring group cohesion (Buckner 1998). Typical items of the scale include "I feel like I belong to this group"; "If I needed advice about something I could go to someone in my group". The response categories are agree and disagree. Few questions will be added as well to assess mobilization skills.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

For girls' and boys'

  • Aged 12-15 years
  • Unmarried
  • Usual resident of the community

For Community Members

  • Aged 25 years or more and usual resident of the community

For fathers' and mothers'

  • Father (or mother) of adolescent girl or boy group member

Exclusion Criteria:

For girls' and boys'

  • Aged <12 or >15 years
  • Married
  • Not a usual resident of the community

For Community Members

  • Aged <25 years or not a usual resident of the community

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03965273


Contacts
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Contact: M. A. Salam Khan, MBA (+88-02) 9827084 salamk@icddrb.org

Locations
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Bangladesh
Community Recruiting
Rangpur, Bangladesh, 5450
Contact: Mahfuz Al Mamun, MS    (+88-02) 9827001 ext 2202    mahfuzmamun@icddrb.org   
Sub-Investigator: Kausar Parvin, MS         
Sub-Investigator: Aloka Talukder, MA         
Sub-Investigator: Mahfuz Al Mamun, MS         
Sponsors and Collaborators
International Centre for Diarrhoeal Disease Research, Bangladesh
CARE Bangladesh
Gram Bikash Kendra (GBK)
CARE USA
Investigators
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Principal Investigator: Ruchira Tabassum Naved, Ph.D Senior Scientist

Publications:
UNFPA. Fact sheet: Young people and times of change. New York: United Nations Population Fund; 2009.
Innocenti Research Centre. Early marriage: Child spouses. Florence, Italy: United Nations Children's Fund; 2001. https://www.unicef-irc.org/publications/pdf/digest7e.pdf
Human Rights Watch. Marry before your house is swept away: Child marriage in Bangladesh. New York: Human Rights Watch; 2015. http://reliefweb.int/sites/reliefweb.int/files/resources/bangladesh0615_ForUpload_0_0.pdf
National Institute of Population Research and Training (NIPORT), Mitra and Associates, and ICF International. Bangladesh Demographic and Health Survey 2014. Dhaka, Bangladesh, and Rockville, Maryland, USA: NIPORT, Mitra and Associates, and ICF International. 2016.
Ministry of Health, Nepal, New ERA, and ICF. Nepal Demographic and Health Survey 2016. Kathmandu, Nepal: Ministry of Health, Nepal. 2017.
Gulemetova-Swan M. Evaluating the impact of conditional cash transferprograms on adolescent decisions about marriage and fertility: The case of Oportunidades. Philadelphia: University of Pennsylvania; 2009. https://search.proquest.com/docview/304980107
Angrist J, Bettinger E, Bloom E, King E, & Kremer M. Vouchers for private schooling inColombia: Evidence from a randomized natural experiment. Am Econ Rev. 2002; 92:1535e58. (DOI): 10.3386/w8343. https://www.nber.org/papers/w8343.pdf
Pande R, Kurz K, Walia S, et al. Improving the reproductive health ofmarried and unmarried youth in India: Evidence of effectiveness and costsfrom community-based interventions. Washington, D.C.: InternationalCenter for Research on Women (ICRW); 2006. https://www.icrw.org/wp-content/uploads/2016/10/Improving-the-Reproductive-Health-of-Married-and-Unmarried-Youth-in-India.pdf
Amin S. Empowering adolescent girls in rural Bangladesh: Kishori Abhijan. New York: Population Council; 2011. https://www.popcouncil.org/uploads/pdfs/TABriefs/13_KishoriAbhijan.pdf
Amin S, Ahmed J, Saha J, Hossain I, &Haque EF. Delaying child marriage through community-based skills-development programs for girls: results from a randomized controlled study in rural Bangladesh. New York and Dhaka, Bangladesh: Population Council; 2016. https://www.popcouncil.org/uploads/pdfs/2016PGY_BALIKA_EndlineReport.pdf
ChaeS,& Ngo TD. The global state of evidence on interventions to prevent child marriage. GIRL Center Research Brief No. 1. New York: Population Council; 2017. https://www.popcouncil.org/uploads/pdfs/2017PGY_GIRLCenterResearchBrief_01.pdf
Jain S, &Kurz K. New Insights on Preventing Child Marriage: A Global Analysis of Factors and Programs. Washington, DC:International Center for Research on Women (ICRW); 2007. http://lastradainternational.org/lsidocs/icrw_child_marriage_0607.pdf
Mukherjee S, Singh S, Gupta SD, Pande R, &Basu S. Knot ready: Lessons from India on delaying marriage for girls. Washington, DC: International Centerfor Research on Women (ICRW) and EngenderHealth; 2008. https://www.icrw.org/wp-content/uploads/2016/10/Knot-Ready-Lessons-from-India-on-Delaying-Marriage-for-Girls.pdf
HervishA, & Feldman-Jacobs C. Who Speaks for Me? Ending Child Marriage. Washington, DC: Population Reference Bureau; 2011. https://assets.prb.org/pdf11/ending-child-marriage.pdf
CARE International. THE TIPPING POINT PROJECT: Community Participatory Analysis Study: Summary Findings on Child Marriage in Bangladesh. Geneva, Switzerland: CARE International; 2016. https://caretippingpoint.org/wp-content/uploads/2016/04/care_tp_compressed-report_bangladesh-english.pdf
CARE. CARE Global VSLA reach 2017. 2017. https://insights.careinternational.org.uk/media/k2/attachments/CARE-VSLA-Global-Outreach-Report-2017.pdf
Pulerwitz J, & Barker G. Measuring attitudes toward gender norms among young men inBrazil: Development and psychometric evaluation of the GEM scale. Men and Masculinities,2007: 10(3), 322-338. https://promundoglobal.org/wp-content/uploads/2014/12/Measuring-Attitudes-toward-Gender-Norms-among-Young-Men-in-Brazil-Development-and-Psychometric-Evaluation-of-the-GEM-Scale.pdf
Das M, Ghosh S, Verma R, O'Connor B, Fewer S, Virata MC& Miller E. Gender attitudes and violence among urban adolescent boys in India. International Journal of Adolescence and Youth. 2014: 19(1): 99-112. DOI: 10.1080/02673843.2012.716762. https://www.tandfonline.com/doi/full/10.1080/02673843.2012.716762
Bienvenn MJ. An interpersonal communication inventory. The Journal of Communication. 1971; 21 (4): 381-.388. https://doi.org/10.1111/j. https://onlinelibrary.wiley.com/doi/pdf/10.1111/j.1460-2466.1971.tb02937.x
Bienvenn MJ, & Stewart. Dimensions of Interpersonal Communication. The Journal of Interpersonal Communication. 1976; 93 (1): 105-111. https://doi.org/10.1080/00223980.1976.9921380. https://psycnet.apa.org/buy/1981-27729-001
Huang Y-C, & Lin S-H. An inventory for assessing interpersonal communication competence of college students. British Journal of Guidance & Counselling. 2016. https://doi.org/10.1080/03069885.2016.1237614. https://www.tandfonline.com/doi/abs/10.1080/03069885.2016.1237614?journalCode=cbjg20
Naved RT, & Amin S. (Eds.). Growing up safe and healthy (SAFE): Baseline report on sexual and reproductive health and rights and violence against women and girls in Dhaka slums. Dhaka: icddr,b; 2012. https://www.popcouncil.org/uploads/pdfs/2012PGY_SAFEBaseline_3.pdf
Cialdini RB,&Trost MR. Social Influence: Social Norms, Conformity and Compliance. In DT Gilbert, ST Fiske,& GLindzey(Eds.), The Handbook of Social Psychology, fourth edition, pp. 151-192.1998. http://www.communicationcache.com/uploads/1/0/8/8/10887248/social_influence_-_social_norms_conformity_and_compliance_1998.pdf
Bicchieri C. The grammar of society: The nature and dynamics of social norms. New York: Cambridge University Press; 2006. DOI: 10.1017/CBO9780511616037. https://www.researchgate.net/publication/238345035_The_Grammar_of_Society_The_Nature_and_Dynamics_of_Social_Norms
Bicchieri C. Norms, conventions, and the power of expectations. In N. Cartwright& E.Montuschi(Eds.), Philosophy of Social Science. New York: Oxford University Press; 2012. https://repository.upenn.edu/cgi/viewcontent.cgi?article=1001&context=belab
Buckner JC. The development of an instrument to measure neighbourhood cohesion.American Journal of Community Psychology. 1988; 16(6): 771-791. DOI: 10.1007/BF00930892. https://onlinelibrary.wiley.com/doi/abs/10.1007/BF00930892
Corbin J, Strauss A. Basics of qualitative research: Techniques and procedures for developing grounded theory 3e. Third Edition: Sage Publications; 2008. DOI: 10.21225/D5G01T. https://www.researchgate.net/publication/277197202_Basics_of_Qualitative_Research_Techniques_and_Procedures_for_Developing_Grounded_Theory
Charmaz K. Constructing grounded theory: A practical guide through qualitative analysis. Sage Publications; 2006. http://www.sxf.uevora.pt/wp-content/uploads/2013/03/Charmaz_2006.pdf
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Responsible Party: International Centre for Diarrhoeal Disease Research, Bangladesh
ClinicalTrials.gov Identifier: NCT03965273    
Other Study ID Numbers: PR-18056
First Posted: May 29, 2019    Key Record Dates
Last Update Posted: June 28, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be shared according to icddr,b's official policy and as per requirement of the approved protocol.
Time Frame: After three years of the completion of the study
Access Criteria: The data could be shared on request from researchers who will use data absolutely on non-profitable purpose. The request has to be reached to Ms. Armana Ahmed (aahmed@icddrb.org), Head, Research Administration, icddr,b. The icddr,b research administration will then review and decide about sharing de-identified data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by International Centre for Diarrhoeal Disease Research, Bangladesh:
Child marriage
Tipping Point
CRCT
Impact
Bangladesh