Evaluation of Tipping Point
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03965273|
Recruitment Status : Recruiting
First Posted : May 29, 2019
Last Update Posted : June 28, 2019
|Condition or disease||Intervention/treatment||Phase|
|Child Marriage||Behavioral: Full TP Behavioral: Light TP||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2699 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- 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.
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
|Contact: M. A. Salam Khan, MBA||(+88-02) email@example.com|
|Rangpur, Bangladesh, 5450|
|Contact: Mahfuz Al Mamun, MS (+88-02) 9827001 ext 2202 firstname.lastname@example.org|
|Sub-Investigator: Kausar Parvin, MS|
|Sub-Investigator: Aloka Talukder, MA|
|Sub-Investigator: Mahfuz Al Mamun, MS|
|Principal Investigator:||Ruchira Tabassum Naved, Ph.D||Senior Scientist|