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Stepping Stones and Creating Futures Intervention Trial

Stepping Stones and Creating Futures Intervention Trial

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03022370
Enrollment
1351
Registered
2017-01-16
Start date
2015-10-31
Completion date
2018-10-31
Last updated
2020-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

IPV, Sexual Violence

Keywords

informal settlements, poverty

Brief summary

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.

Interventions

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.

Sponsors

London School of Hygiene and Tropical Medicine
CollaboratorOTHER
Department for International Development, United Kingdom
CollaboratorOTHER_GOV
Project Empower
CollaboratorOTHER
University of KwaZulu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)24 months post baselinePhysical 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.
Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)24 months post baselineSexual 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.
Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)24 months post baselineSevere 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.
Controlling Behaviours24 months post baselineControlling 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
Earnings in Past Month24 months post baselineA 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

MeasureTime frameDescription
Number of People Quarreling With Partner About Alcohol Use24 months post baselineA 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.
Last Sexual Partner of Participant is the Main Partner24 months post baselineA 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.
Transactional Sex Past Year24 months post baselineFive 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.
Gender Attitudes24 months post baselineModified 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)
Stress About Lack of Work24 months post baselineFour 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)
Individual's Ability to Mobilise Money in an Emergency24 months post baselineA 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.
Stolen Because of Hunger in Past Month24 months post baselineSingle 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.
Shame About Lack of Work24 months post baselineFour 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)
Depressive Symptomology24 months post baselinePast 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.
Number of Participants Reporting Suicidal Ideation24 months post baselinePast four week suicidal ideation was assessed using a single item question. Responses are either 0=no, or 1=yes.
Life Circumstances24 months post baselineFour 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.
Problem Alcohol Use24 months post baselineProblem 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.

Countries

South Africa

Participant flow

Participants by arm

ArmCount
Women - Intervention
Women who received the Stepping Stones and Creating Futures intervention
339
Men - Intervention
Men who received the intervention
338
Women - Control
Women in the wait list control
338
Men - Control
Men in the wait list control
336
Total1,351

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyDeath612
Overall StudyLost to Follow-up174109

Baseline characteristics

CharacteristicTotalMen - InterventionWomen - ControlMen - ControlWomen - Intervention
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
1351 Participants338 Participants338 Participants336 Participants339 Participants
Race and Ethnicity Not Collected0 Participants
Region of Enrollment
South Africa
1351 participants338 participants338 participants336 participants339 participants
Sex: Female, Male
Female
677 Participants0 Participants338 Participants0 Participants339 Participants
Sex: Female, Male
Male
674 Participants338 Participants0 Participants336 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
5 / 3393 / 3383 / 3387 / 336
other
Total, other adverse events
0 / 3390 / 3380 / 3380 / 336
serious
Total, serious adverse events
3 / 3392 / 3380 / 3380 / 336

Outcome results

Primary

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

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionAny Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)134 Participants
Men - InterventionAny Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)86 Participants
Women - ControlAny Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)155 Participants
Men - ControlAny Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)118 Participants
p-value: =0.68695% CI: [0.62, 1.37]Regression, Logistic
p-value: =0.03295% CI: [0.51, 0.97]Regression, Logistic
Primary

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

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionAny Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)86 Participants
Men - InterventionAny Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)52 Participants
Women - ControlAny Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)101 Participants
Men - ControlAny Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)73 Participants
p-value: 0.55595% CI: [0.64, 1.28]Regression, Logistic
p-value: 0.07295% CI: [0.54, 1.03]Regression, Logistic
Primary

Controlling Behaviours

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

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionControlling Behaviours9.75 score on a scale
Men - InterventionControlling Behaviours9.96 score on a scale
Women - ControlControlling Behaviours9.70 score on a scale
Men - ControlControlling Behaviours9.96 score on a scale
p-value: 0.98495% CI: [-0.88, 0.86]Regression, Linear
p-value: 0.83995% CI: [-0.51, 0.63]Regression, Linear
Primary

Earnings in Past Month

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.

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionEarnings in Past Month565 Rands
Men - InterventionEarnings in Past Month988 Rands
Women - ControlEarnings in Past Month385 Rands
Men - ControlEarnings in Past Month817 Rands
p-value: <0.000195% CI: [0.43, 1.51]Tobit
p-value: 0.52195% CI: [-0.42, 0.83]Tobit
Primary

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

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionPast Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)151 Participants
Men - InterventionPast Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)99 Participants
Women - ControlPast Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)171 Participants
Men - ControlPast Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)135 Participants
p-value: 0.67295% CI: [0.66, 1.31]Regression, Logistic
p-value: 0.01995% CI: [0.52, 0.94]Regression, Logistic
Secondary

Depressive Symptomology

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.

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionDepressive Symptomology21.95 score on a scale
Men - InterventionDepressive Symptomology19.26 score on a scale
Women - ControlDepressive Symptomology23.11 score on a scale
Men - ControlDepressive Symptomology20.35 score on a scale
p-value: 0.06795% CI: [-3.14, 0.11]Regression, Linear
p-value: 0.39895% CI: [-2.48, 0.99]Regression, Linear
Secondary

Gender Attitudes

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)

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionGender Attitudes21.98 score on a scale
Men - InterventionGender Attitudes24.99 score on a scale
Women - ControlGender Attitudes21.65 score on a scale
Men - ControlGender Attitudes25.15 score on a scale
p-value: 0.71895% CI: [-1.09, 1.58]Regression, Linear
p-value: 0.71295% CI: [-1.87, 1.28]Regression, Linear
Secondary

Individual's Ability to Mobilise Money in an Emergency

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionIndividual's Ability to Mobilise Money in an Emergency27 Participants
Men - InterventionIndividual's Ability to Mobilise Money in an Emergency37 Participants
Women - ControlIndividual's Ability to Mobilise Money in an Emergency30 Participants
Men - ControlIndividual's Ability to Mobilise Money in an Emergency31 Participants
p-value: 0.17495% CI: [0.89, 1.9]Regression, Logistic
p-value: 0.12995% CI: [0.89, 2.5]Regression, Logistic
Secondary

Last Sexual Partner of Participant is the Main Partner

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionLast Sexual Partner of Participant is the Main Partner185 Participants
Men - InterventionLast Sexual Partner of Participant is the Main Partner138 Participants
Women - ControlLast Sexual Partner of Participant is the Main Partner182 Participants
Men - ControlLast Sexual Partner of Participant is the Main Partner159 Participants
p-value: 0.52695% CI: [0.73, 1.84]Regression, Logistic
p-value: 0.93195% CI: [0.67, 1.56]Regression, Logistic
Secondary

Life Circumstances

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.

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionLife Circumstances10.28 score on a scale
Men - InterventionLife Circumstances10.59 score on a scale
Women - ControlLife Circumstances9.88 score on a scale
Men - ControlLife Circumstances10.03 score on a scale
p-value: 0.67995% CI: [-0.52, 0.8]Regression, Linear
p-value: 0.0895% CI: [-0.07, 1.16]Regression, Linear
Secondary

Number of Participants Reporting Suicidal Ideation

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

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionNumber of Participants Reporting Suicidal Ideation83 Participants
Men - InterventionNumber of Participants Reporting Suicidal Ideation49 Participants
Women - ControlNumber of Participants Reporting Suicidal Ideation72 Participants
Men - ControlNumber of Participants Reporting Suicidal Ideation65 Participants
p-value: 0.22895% CI: [0.85, 1.97]Regression, Logistic
p-value: 0.55895% CI: [0.53, 1.41]Regression, Logistic
Secondary

Number of People Quarreling With Partner About Alcohol Use

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionNumber of People Quarreling With Partner About Alcohol Use39 Participants
Men - InterventionNumber of People Quarreling With Partner About Alcohol Use54 Participants
Women - ControlNumber of People Quarreling With Partner About Alcohol Use47 Participants
Men - ControlNumber of People Quarreling With Partner About Alcohol Use79 Participants
p-value: 0.63595% CI: [0.67, 1.92]Regression, Logistic
p-value: 0.25695% CI: [0.41, 1.27]Regression, Logistic
Secondary

Problem Alcohol Use

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.

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionProblem Alcohol Use4.27 score on a scale
Men - InterventionProblem Alcohol Use6.81 score on a scale
Women - ControlProblem Alcohol Use4.62 score on a scale
Men - ControlProblem Alcohol Use7.97 score on a scale
p-value: 0.8195% CI: [-1.21, 0.95]Regression, Linear
p-value: 0.04195% CI: [-2.01, -0.04]Regression, Linear
Secondary

Shame About Lack of Work

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)

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionShame About Lack of Work10.3 score on a scale
Men - InterventionShame About Lack of Work10.7 score on a scale
Women - ControlShame About Lack of Work10.7 score on a scale
Men - ControlShame About Lack of Work10.9 score on a scale
p-value: 0.13795% CI: [-0.72, 0.24]Regression, Linear
p-value: 0.72195% CI: [-0.58, 0.4]Regression, Linear
Secondary

Stolen Because of Hunger in Past Month

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionStolen Because of Hunger in Past Month88 Participants
Men - InterventionStolen Because of Hunger in Past Month91 Participants
Women - ControlStolen Because of Hunger in Past Month84 Participants
Men - ControlStolen Because of Hunger in Past Month105 Participants
p-value: 0.17495% CI: [0.89, 1.9]Regression, Logistic
p-value: 0.83695% CI: [0.64, 1.43]Regression, Logistic
Secondary

Stress About Lack of Work

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)

Time frame: 24 months post baseline

ArmMeasureValue (MEAN)
Women - InterventionStress About Lack of Work12.0 score on a scale
Men - InterventionStress About Lack of Work11.8 score on a scale
Women - ControlStress About Lack of Work12.1 score on a scale
Men - ControlStress About Lack of Work12.0 score on a scale
p-value: 0.33295% CI: [-0.7, 0.24]Regression, Linear
p-value: 0.46895% CI: [-0.71, 0.32]Regression, Linear
Secondary

Transactional Sex Past Year

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.

Time frame: 24 months post baseline

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Women - InterventionTransactional Sex Past Year111 Participants
Men - InterventionTransactional Sex Past Year138 Participants
Women - ControlTransactional Sex Past Year118 Participants
Men - ControlTransactional Sex Past Year146 Participants
p-value: 0.69195% CI: [0.63, 1.36]Regression, Logistic
p-value: 0.69295% CI: [0.6, 1.4]Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Mar 10, 2026