Trial Outcomes & Findings for Stepping Stones and Creating Futures Intervention Trial (NCT NCT03022370)

NCT ID: NCT03022370

Last Updated: 2020-06-04

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 1351 participants
• Primary outcome timeframe: 24 months post baseline
• Results posted on: 2020-06-04

Participant Flow

Participant milestones

Measure	Stepping Stones and Creating Futures Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.	Wait-list Control Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.
Overall Study STARTED	677	674
Overall Study COMPLETED	497	553
Overall Study NOT COMPLETED	180	121

Reasons for withdrawal

Measure	Stepping Stones and Creating Futures Participants receive the Stepping Stones and Creating Futures intervention, comprising of 21 participatory/inter-active sessions, delivered by a trained facilitators. Each session last approximately 3 hours. Sessions are delivered twice a week. Sessions are primarily single sex, with 20 participants per group.	Wait-list Control Participants receive no intervention until after final data collection occurs, at which point they will be offered Stepping Stones and Creating Futures.
Overall Study Death	6	12
Overall Study Lost to Follow-up	174	109

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Women - Intervention n=339 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=338 Participants Men who received the intervention	Women - Control n=338 Participants Women in the wait list control	Men - Control n=336 Participants Men in the wait list control	Total n=1351 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=339 Participants	0 Participants n=338 Participants	0 Participants n=338 Participants	0 Participants n=336 Participants	0 Participants n=1351 Participants
Age, Categorical Between 18 and 65 years	339 Participants n=339 Participants	338 Participants n=338 Participants	338 Participants n=338 Participants	336 Participants n=336 Participants	1351 Participants n=1351 Participants
Age, Categorical >=65 years	0 Participants n=339 Participants	0 Participants n=338 Participants	0 Participants n=338 Participants	0 Participants n=336 Participants	0 Participants n=1351 Participants
Sex: Female, Male Female	339 Participants n=339 Participants	0 Participants n=338 Participants	338 Participants n=338 Participants	0 Participants n=336 Participants	677 Participants n=1351 Participants
Sex: Female, Male Male	0 Participants n=339 Participants	338 Participants n=338 Participants	0 Participants n=338 Participants	336 Participants n=336 Participants	674 Participants n=1351 Participants
Race and Ethnicity Not Collected	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment South Africa	339 participants n=339 Participants	338 participants n=338 Participants	338 participants n=338 Participants	336 participants n=336 Participants	1351 participants n=1351 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Any Past Year Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)	134 Participants	86 Participants	155 Participants	118 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Any Past Year Sexual Intimate Partner Violence Perpetration (Men) and Experience (Women)	86 Participants	52 Participants	101 Participants	73 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Past Year Severe Sexual and/or Physical Intimate Partner Violence Perpetration (Men) and Experience (Women)	151 Participants	99 Participants	171 Participants	135 Participants

PRIMARY outcome

Timeframe: 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

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Controlling Behaviours	9.75 score on a scale Interval 9.17 to 10.32	9.96 score on a scale Interval 9.36 to 10.56	9.70 score on a scale Interval 9.12 to 10.22	9.96 score on a scale Interval 9.44 to 10.47

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Earnings in Past Month	565 Rands Interval 443.0 to 688.0	988 Rands Interval 798.0 to 1177.0	385 Rands Interval 268.0 to 503.0	817 Rands Interval 594.0 to 1038.0

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Gender Attitudes	21.98 score on a scale Interval 20.78 to 23.18	24.99 score on a scale Interval 23.58 to 26.39	21.65 score on a scale Interval 20.74 to 22.72	25.15 score on a scale Interval 23.93 to 26.38

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Depressive Symptomology	21.95 score on a scale Interval 20.7 to 23.2	19.26 score on a scale Interval 18.06 to 20.47	23.11 score on a scale Interval 21.86 to 24.36	20.35 score on a scale Interval 19.26 to 20.47

SECONDARY outcome

Timeframe: 24 months post baseline

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

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Number of Participants Reporting Suicidal Ideation	83 Participants	49 Participants	72 Participants	65 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Life Circumstances	10.28 score on a scale Interval 9.82 to 10.75	10.59 score on a scale Interval 10.13 to 11.06	9.88 score on a scale Interval 9.47 to 10.29	10.03 score on a scale Interval 9.62 to 10.43

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Problem Alcohol Use	4.27 score on a scale Interval 3.49 to 5.06	6.81 score on a scale Interval 5.86 to 7.75	4.62 score on a scale Interval 3.8 to 5.45	7.97 score on a scale Interval 6.94 to 8.99

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=129 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=160 Participants Men who received the intervention	Women - Control n=138 Participants Women in the wait list control	Men - Control n=184 Participants Men in the wait list control
Number of People Quarreling With Partner About Alcohol Use	39 Participants	54 Participants	47 Participants	79 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=236 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=220 Participants Men who received the intervention	Women - Control n=243 Participants Women in the wait list control	Men - Control n=258 Participants Men in the wait list control
Last Sexual Partner of Participant is the Main Partner	185 Participants	138 Participants	182 Participants	159 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=236 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=220 Participants Men who received the intervention	Women - Control n=243 Participants Women in the wait list control	Men - Control n=258 Participants Men in the wait list control
Transactional Sex Past Year	111 Participants	138 Participants	118 Participants	146 Participants

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Shame About Lack of Work	10.3 score on a scale Interval 9.9 to 10.6	10.7 score on a scale Interval 10.4 to 11.1	10.7 score on a scale Interval 10.4 to 10.9	10.9 score on a scale Interval 10.6 to 11.2

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Stress About Lack of Work	12.0 score on a scale Interval 11.6 to 12.3	11.8 score on a scale Interval 11.5 to 12.2	12.1 score on a scale Interval 11.8 to 12.5	12.0 score on a scale Interval 11.7 to 12.3

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Individual's Ability to Mobilise Money in an Emergency	27 Participants	37 Participants	30 Participants	31 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Women - Intervention n=260 Participants Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=237 Participants Men who received the intervention	Women - Control n=285 Participants Women in the wait list control	Men - Control n=268 Participants Men in the wait list control
Stolen Because of Hunger in Past Month	88 Participants	91 Participants	84 Participants	105 Participants

Adverse Events

Women - Intervention

Serious events: 3 serious events

Other events: 0 other events

Deaths: 5 deaths

Men - Intervention

Serious events: 2 serious events

Other events: 0 other events

Deaths: 3 deaths

Women - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 3 deaths

Men - Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 7 deaths

Serious adverse events

Measure	Women - Intervention n=339 participants at risk Women who received the Stepping Stones and Creating Futures intervention	Men - Intervention n=338 participants at risk Men who received the intervention	Women - Control n=338 participants at risk Women in the wait list control	Men - Control n=336 participants at risk Men in the wait list control
Social circumstances Violence experience	0.00% 0/339 • 24 months of follow up	0.59% 2/338 • Number of events 2 • 24 months of follow up	0.00% 0/338 • 24 months of follow up	0.00% 0/336 • 24 months of follow up
Social circumstances Hospitalisation	0.88% 3/339 • Number of events 3 • 24 months of follow up	0.00% 0/338 • 24 months of follow up	0.00% 0/338 • 24 months of follow up	0.00% 0/336 • 24 months of follow up

Other adverse events

Adverse event data not reported

Additional Information

Dr Andrew Gibbs

SAMRC

Phone: +27(0)312034899

Email: andrew.gibbs@mrc.ac.za

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place