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Completed

NCT Number: NCT03022370

Stepping Stones and Creating Futures Intervention Trial

This study evaluates whether the behavioural/structural interventions of Stepping Stones and Creating Futures can reduce the incidence of intimate partner violence in urban informal settlements amongst young people. Half the participants will receive the interventions, while the other half will be in a control wait-list, only receiving the intervention after final data collection.

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Key information

Conditions

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Gender and Health Research Unit, South African Medical Research Council

Durban, KwaZulu-Natal, 4001, South Africa

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Normally resident in informal settlement cluster
  • Not formally employed
  • Able to communicate in main study languages (English, isiZulu, iXhosa)

Exclusion criteria

  • Under 18
  • Mental deficit (learning difficulty, mental illness or substance abuse)

Treatment and study plan

Stepping Stones and Creating Futures

Behavioral

Stepping Stones consists of 10 sessions. It seeks to strengthen relationships and to transform views on gender and in the process impact on exposure to, or participation in, gender-based violence and HIV risk. These cover gender and peer influences our actions; sex and love; conception and contraception; STIs and HIV; safer sex and condoms; GBV; motivations for behaviour (including influences of alcohol and poverty); and communication skills.

Creating Futures is a facilitated group intervention of eleven sessions. It seeks to strengthen livelihoods. The key sessions include: setting medium term livelihood goals, the need for assets and coping with crises; social resources for livelihoods (trust and community participation); getting and keeping jobs; and savings and spending.

Primary outcomes

  1. Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)

    Time frame: 24 months post baseline

    Physical intimate partner violence is assessed using five items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.

  2. Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)

    Time frame: 24 months post baseline

    Sexual intimate partner violence is assessed using three items based on the WHO VAW scale. A positive response to any item leads to a person being classified as perpetrating (men) and experiencing (women) in the past year. With 0=none, 1=yes.

  3. Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)

    Time frame: 24 months post baseline

    Severe sexual and/or physical intimate partner violence perpetration (men) and experience (women) is assessed using 8 items. Past year severe sexual and/or physical IPV is assessed as positive if a person responds to two (or more) items as once, or one item as few (or more), essentially creating a more than once categorization.

  4. Controlling Behaviours

    Time frame: 24 months post baseline

    Controlling behaviours are assessed using a modified Sexual Relationship Power (SRP) scale. Men's control of female sexual partner's and women's experience of controlling behaviours from a male partner. A mean score is calculated with higher scores indicating more controlling (bad). Range: 0-24

  5. Earnings in Past Month

    Time frame: 24 months post baseline

    A single item question asks "Considering all the money you earned from jobs or selling things (excluding grants), how much did you earn last month?" Responses are in Rands and a continuous scale, with no upper limit.

Secondary outcomes

  1. Gender Attitudes

    Time frame: 24 months post baseline

    Modified gender equitable men's scale (GEMS) assess participant's gender attitudes. A mean score is calculated with higher scores indicative of more gender inequitable attitudes (range: 0-60)

  2. Depressive Symptomology

    Time frame: 24 months post baseline

    Past week depressive symptomology is assessed by the Centre for Epidemiological Studies Depression (CESD) scale, with the full twenty items (range 0-60). A mean score is calculated, with higher scores indicating more depression.

  3. Number of Participants Reporting Suicidal Ideation

    Time frame: 24 months post baseline

    Past four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.

  4. Life Circumstances

    Time frame: 24 months post baseline

    Four items modified from the Satisfaction with Life Scale (SWLS) by Denier et al. (1985), with items on a five point Likert Scale (range 0-20) higher scores indicative of greater life satisfaction.

  5. Problem Alcohol Use

    Time frame: 24 months post baseline

    Problem drinking in the past year is assessed using the AUDIT (alcohol use disorders identification test) scale. With a range of 0-40, and recoded with scores of 8 or more classifing a participant as having potentially problematic alcohol use.

  6. Number of People Quarreling With Partner About Alcohol Use

    Time frame: 24 months post baseline

    A single item binary response question asks whether participants have argued about alcohol with their sexual partner in the past year (0=no; 1=yes). Only asked to those who reported alcohol use in the past year.

  7. Last Sexual Partner of Participant is the Main Partner

    Time frame: 24 months post baseline

    A single item assess who the participant last had sex with, with possible responses being: "main partner", "casual partner", "once-off sex partner" or "ex-partner". As per the protocol, we recategorised this into either "1=main partner" or "0=other". Positive change is towards main partner. And the reported number (proportion) is those reporting Main partner.

  8. Transactional Sex Past Year

    Time frame: 24 months post baseline

    Five item scale asks about transactional sex with casual or once-off sexual partners in the past year based on the scale developed and tested by Dunkle et al (2004). Each item has a no/yes response. A response of yes to any is classified as having engaged in transactional sex.

  9. Shame About Lack of Work

    Time frame: 24 months post baseline

    Four items assess participants' feelings of shame about not enough work, based on a scale developed for use in the IMAGES study, with . Mean score calculated, with higher scores indicative of more shame (range: 4-16)

  10. Stress About Lack of Work

    Time frame: 24 months post baseline

    Four items assess participants' feelings of stress about not enough work, based on a scale developed for the IMAGES study. Mean score calculated, with higher scores indicating more stress (range: 4-20)

  11. Individual's Ability to Mobilise Money in an Emergency

    Time frame: 24 months post baseline

    A single item asks participants how hard it would be to mobilise R200 (~US$15) in an emergency. Those responding it would be "very difficult, or somewhat difficult" are classified as finding it hard (=1). Those responding "fairly easy or easy" are classified as not finding it hard (=0). Reported number (proportion) is of those finding it hard to mobilise money in an emergency. A positive change is towards a lower proportion.

  12. Stolen Because of Hunger in Past Month

    Time frame: 24 months post baseline

    Single item question asks about stealing because of lack of food or money in the past month with responses "never", "once", "every week" or "every day". Responses are recoded, as per protocol, into "0=never" and "1=once or more". The number/proportion of those stealing in the past month is reported. A lower proportion is a positive change.

Sponsors and collaborators

Lead sponsor

University of KwaZulu

Other

Collaborators

  • Department for International Development, United Kingdom
  • London School of Hygiene and Tropical Medicine
  • Project Empower

Registry information

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Jan 16, 2017
Registry last updated
Jun 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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