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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04458077
Other study ID # 2017-01-9464
Secondary ID OPP1158584
Status Completed
Phase N/A
First received
Last updated
Start date August 30, 2020
Est. completion date April 30, 2021

Study information

Verified date November 2021
Source University of California, Berkeley
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The primary aim of the Discover Learning Project (Discover) is to test an intervention for Very Young Adolescents (VYAs) to promote positive, gender norm transformative, social emotional and identity learning (SEIL). A secondary aim is to better identify effective components of Discover that are scalable requiring the lowest resources to implement


Description:

This project builds on research from transdisciplinary developmental science that indicates that this period, which the investigators will call early adolescence (ages 10-14), is a period of dynamic maturational changes. These include the onset of pubertal development, which begins a period of rapid physical growth (including extensive brain development) and sexual maturation, as well as changes in cognitive, social, emotional, psychological, and behavioral processes. An emerging body of evidence supports the idea that this dynamic period of maturation is a sensitive period for social, emotional and motivational learning-in ways that can have enduring effects on a broad range of developmental trajectories including sexual and reproductive health, mental health, gender-based violence, education retention and attainment, and social development. A foundational element of this research focuses on the social-emotional re-orientation of the developing brain at the onset of puberty, which appears to create natural affinities for discovery learning particularly in the social domain. In contrast to didactic learning models, discovery learning is a process through which learners engage in self-motivated inquiry, supported by teachers/facilitators, information and materials, in order to "discover" the intended content (Hammer, 1997). Key elements to creating sustainable discovery learning include: a) engaging motivation and natural curiosity and b) providing social scaffolding that includes a balance of monitoring/support while also promoting youth-driven discoveries (individually and in small groups). From a developmental science perspective, the beginning of puberty is associated with two important maturational changes that impact learning opportunities: 1) a general increase in the tendency to explore, discover, and to seek novelty/excitement; and 2) a particularly strong increase in natural curiosity to explore and understand one's larger social world, including social roles, social hierarchies, and an increased sensitivity to issues of social acceptance, admiration, and learning to establish key aspects of individual identity (Crone & Dahl, 2012). A core element to this early identity development is understanding oneself as a sexual and gendered individual in relation to those around her or him; accordingly, early learning experiences during this developmental window are fundamentally shaping the development of these identities in ways that have profound implications for all areas of health-especially sexual and reproductive health and vulnerability to gender-based exploitation and disadvantage. The primary aim of this project is to develop and test the Discover Learning intervention with a goal of promoting positive, gender norm transformative, social-emotional learning during this crucial early window of opportunity. This work builds on developmentally informed principles that emphasize the importance of orchestrating a sensitive balance between promoting autonomy and providing adult engagement in ways that scaffold the discovery learning experience (Alifieri et al., 2011). The primary content (learning about interpersonal relationships and concepts of Social-Emotional Identity Learning) and method (introducing positive socially scaffolded exploration of the use of digital technology for youth-driven learning) have been chosen to strategically leverage this window of opportunity occurring during this sensitive period of learning. The approach is designed to help youth develop agency, become empowered, and to explore healthy pathways to finding meaning and purpose in their lives. To our knowledge, this is the first use of an integrative developmental science approach to leverage unique learning opportunities in early adolescence to impact broad improvements in health and education.


Recruitment information / eligibility

Status Completed
Enrollment 333
Est. completion date April 30, 2021
Est. primary completion date December 12, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 9 Years to 14 Years
Eligibility Inclusion Criteria: - Boys and girls currently enrolled in school/intervention site - Ages 9-14 Exclusion Criteria: - n/a

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Discover Learning (SEIL)
This mobile-phone-based intervention will assess the effectiveness of 10 SEIL sessions conducted at the household level with VYAs. Activities were designed to be done individually, with siblings/peers, and with parents/caregivers. This intervention will look at how household composition and types of practice that can enhance SEIL learning.

Locations

Country Name City State
Tanzania Miburani Primary School Dar Es Salaam Temeke
Tanzania Sokoine Primary School Dar Es Salaam Temeke
Tanzania Twiga Primary School Dar Es Salaam Temeke
Tanzania Umoja Primary School Dar Es Salaam Temeke

Sponsors (6)

Lead Sponsor Collaborator
University of California, Berkeley Camara Education, Tanzania, Dalberg Global Development Advisors, Tanzania, Health for a Prosperous Nation, Save the Children, Ubongo Learning Limited

Country where clinical trial is conducted

Tanzania, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in Purpose from baseline to end of intervention Standardized survey from The Dimensions of Identity Development Scale (DIDS) (Mastrotheodoros & Motti-Stefanidi, 2017), validated self-reported instrument. Possible scores range from 0 (strongly disagree) to 3 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Emotional Self-Efficacy from baseline to end of intervention Standardized survey from Adolescent Self Efficacy Questionnaire (Muris et.al, 2001), validated self-reported instrument. Possible scores range from 0 (not at all) to 4 (very well) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Goal Orientation from baseline to end of intervention Standardized survey from Goal Orientation Scale (Dowson and McInerney, 2004), validated self-reported instrument. Possible scores range from 0 (strongly disagree) to 4 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Persistence from baseline to end of intervention Standardized survey from Persistence in Children (Lufi & Cohen, 1987), validated self-reported instrument. Possible scores range from 0 (strongly disagree) to 3 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Empathy from baseline to end of intervention Standardized survey from Empathy (Overgaaw, et al, 2017), validated self-reported instrument. Possible scores range from 0 (not true) to 2 (often true) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Internalizing Symptoms from baseline to end of intervention Standardized survey from African Youth Psychological Assessment (Betancourt, 2014), validated self-reported instrument. Possible scores range from 0 (never) to 3 (all the time) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Externalizing Symptoms from baseline to end of intervention Standardized survey from African Youth Psychological Assessment (Betancourt, 2014), validated self-reported instrument. Possible scores range from 0 (never) to 3 (all the time) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Academic Self-Efficacy from baseline to end of intervention Standardized survey from Adolescent Self Efficacy Questionnaire (Muris et.al, 2001), validated self-reported instrument. Possible scores range from 0 (not at all) to 4 (very well) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Curiosity from baseline to end of intervention Standardized survey from Gender-free curiosity inventory (Reijo Byman, 2016), validated self-reported instrument in curiosity. Possible scores range from 0 (strongly disagree) to 3 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Teamwork from baseline to end of intervention Standardized survey from Team Skills Index (Zhuang et al, 2008), validated self-reported instrument in curiosity. Possible scores range from 0 (never) to 3 (always) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Growth Mindset from baseline to end of intervention Standardized survey from Dweck's Theories of Intelligence (Growth Mindset Scale) (Ingebrigsten, 2018), validated self-reported instrument in curiosity. Possible scores range from 0 (never) to 3 (always) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Outlook in Learning from baseline to end of intervention Standardized survey from Dweck's Theories of Intelligence (Growth Mindset Scale) (Ingebrigsten, 2018), validated self-reported instrument in curiosity. Possible scores range from 0 (never) to 3 (always) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Technology Perceptions from baseline to end of intervention Standardized survey from Media and Technology Usage and Attitudes Scale (Rosen et al, 2013), validated self-reported instrument. Possible scores range from 0 (never) to 3 (always) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Social Self-Efficacy from baseline to end of intervention Standardized survey from Adolescent Self Efficacy Questionnaire (Muris et.al, 2001), validated self-reported instrument. Possible scores range from 0 (strongly disagree) to 3 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Prosocial Behavior from baseline to end of intervention Standardized survey from The Dimensions of Identity Development Scale (DIDS) (Mastrotheodoros & Motti-Stefanidi, 2017), validated self-reported instrument. Possible scores range from 1 (strongly disagree) to 4 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Gender Norms and Attitudes from baseline to end of intervention Standardized survey from Discover Gender Norms and Attitudes Scale (under development), self-reported instrument. Possible scores range from 0 (strongly disagree) to 4 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Generosity from baseline to end of intervention Standardized survey from Interpersonal Generosity Scale (IGS) (Smith & Hill, 2009), validated self-reported instrument. Possible scores range from 0 (strongly disagree) to 3 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Utu from baseline to end of intervention Standardized survey from Utu (under development), self-reported instrument. Possible scores range from 0 (strongly disagree) to 4 (strongly agree) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
Primary Change in Bullying from baseline to end of intervention Standardized survey from The Global School-Based Students Health Survey (GSHS), validated self-reported instrument. Possible scores range from 0 (No) to 1 (Yes) Change = Endline - Baseline score Baseline and endline, measured before the intervention and after the intervention (6 weeks)
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