Wakiso Busukuma and Amuru Lamogi subcounties
Kampala, Uganda
NCT Number: NCT05105373
The Implementation science and impact evaluation of PfR programme: A hybrid cRCT design study will use an effectiveness-implementation hybrid type 2 design to a) determine the effectiveness and cost-effectiveness of PfR, and b) determine the feasibility and impact of three different implementation strategies in terms of programme delivery. A cluster randomised controlled trial (cRCT) will examine the effectiveness, cost-effectiveness, and implementation of the Parenting for Respectability (PfR) programme on the reduction of violence against children and gender based violence in comparison to those receiving an hour lecture on parenting in the Wakiso and Amuru districts of Uganda (N = 54 clusters, 2,160 parents, 1,080 children, 1:1 allocation ratio).
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Notify Me1 year–80 year
All sexes
Interventional
Not applicable
Kampala, Uganda
Intimate partner violence (IPV) and violence against children (VAC) are interlinked and are major social, development and public health concerns. Globally it is estimated that approximately 30% ever-partnered women worldwide have experienced physical and/or sexual violence by an intimate partner at some point in their lives. IPV prevalence among women in Uganda is very high. The Uganda Demographic and Health Survey 2018 found that 36% of women had ever experienced partner physical violence, while 22% had ever experienced partner sexual violence. Violence against children is extremely widespread globally, with approximately half of all children - one billion aged 2-17 years - reporting having experienced violence in the past year. Furthermore, one in five women and up to one in ten men have been victims of sexual violence in childhood. The Uganda national VAC survey 2015 found that 59% girls and 68% boys had experienced physical violence in their childhood, and 35% girls and 17% boys had experienced sexual violence in their childhood. Such violence in Uganda and most Sub-Saharan African countries is usually perpetrated by people known to children in their homes and community. IPV and VAC are major causes of morbidity and mortality, they undermine the social functioning of the victims and their families, and have lifetime consequences for physical, sexual, reproductive and mental health. The prevention of both forms of violence would contribute to many Sustainable Development Goals since they strain health systems, lower educational achievement and economic productivity, and undermine economic and social development, and elimination of IPV is essential to Goal Five.
Many studies confirm the link between VAC and IPV, suggesting the need for an integrated approach to their prevention. A recent narrative review identified six ways in which they are interrelated: they have many shared risk factors, starting in the family; social norms legitimise both and discourage children and women from seeking help; both often occur within the same household both can be transmitted across generations; they can have similar consequences across the lifespan, and finally, both intersect in adolescence, a time of heightened vulnerability to violence.
Factors perpetuating IPV and VAC exist at multiple socio-ecological levels. For IPV, familial level factors include having been abused as a child, having an absent or rejecting father, inter-partner conflict, and male control of wealth and decision-making. Community level factors include women's isolation and male peer groups that legitimize men's violence. At the macro level IPV is associated with cultural norms that condone violence within the family, schools and community, establish rigid gender roles and link masculinity to toughness, male honour, dominance and ownership of women, and it thrives where policy, legislation and implementation of laws is weak. VAC is more likely in families that have difficulties developing stable, warm and positive relationships, where parents are unresponsive to their children, have harsh or inconsistent parenting styles, believe that corporal punishment is an acceptable form of discipline or have a poor understanding of child development, and therefore unrealistic expectations about the child's behaviour.
Recognizing that IPV is perpetuated at multiple levels, preventative interventions often focus on other psychosocial problems, e.g. poverty or alcohol abuse, as well as on inter-partner violence, although they are more effective if their main aim is to reduce IPV. The shared familial risk factors for IPV and VAC, and the increasing policy interest in optimizing parenting influence, provides a great opportunity for early intervention. An increasing number of parenting programs are being implemented and tested in LMICs to reduce VAC, and evidence is emerging that, if delivered by trained lay workers, they can be effective in improving child outcomes. However, interventions directly addressing early prevention of both IPV and VAC in LMICS remain limited.
Furthermore, very few parenting programs in LMICs harness cultural drivers and pre-existing motivations to change behaviour. In sub-Saharan Africa little attention has been paid to one of the most important dimensions of parenthood for both mothers and fathers: the need to maintain the family's respectability, in large part achieved through the appropriate behaviour of the children and their parents. This core motivation might be harnessed in the design of interventions to reduce spousal violence, modify negative parenting and encourage sensitive parenting, in order to reduce children's future risk of sexual, physical and/or emotional violence. In Uganda, the investigators are not aware of any parenting programs that deliberately recruit parental couples to complete both single and mixed sex sessions. The Investigators therefore designed a community-based parenting program, - Parenting for Respectability (PfR), - to address this gap in Uganda, and contribute evidence on how a parenting program can address both IPV and VAC. Following careful formative evaluation, the investigators conducted a pre-post study to establish whether there was sufficient evidence of effectiveness to warrant progression to a randomized controlled trial.
The programme has undergone formative evaluation (2014-16), 'Proof of Concept' pre-post outcome evaluation (2016-2019), and with support from Evaluation Fund, is currently being evaluated to assess implementation and scale-up modalities (April 2020-October 2021) in central Uganda. The investment in developing PfR so far has provided important lessons about the acceptability of PfR and how to refine it. Preliminary outcome evidence suggests that a rigorous evaluation of PfR is warranted. The pre-post study has found significant change across primary outcomes for both parent- and child-reports, including large effects for reduced harsh parenting (Cohen's f2 = 0.42, p < .001) and dysfunctional spousal relationships (Cohen's f2 = 0.28, p < .001), as well as increased positive parenting (Cohen's f2 = 0.48, p < .001). The programme has been disseminated widely in Uganda (www.parenting.ug.org), and both government and NGOs have expressed interest to scale it. However, two key uncertainties remain: (i) the optimal way to scale up the intervention in a 'real-world setting', and (ii) whether the evidence of effectiveness would be confirmed through a more rigorous, experimental, evaluation. As a result, this study will combine a rigorous cluster randomised control trial (cRCT) evaluation of PfR with an implementation study using a hybrid type 2 design to examine its effectiveness and cost-effectiveness as well as answer critical contextually relevant implementation science questions. This is essential to ensure that precious resources are not wasted and that there are no harmful unintended consequences from the programme.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
for participating parents or caregivers:
Inclusion criteria
for participating children:
Inclusion criteria
for facilitators:
Inclusion criteria
for community development officers
Exclusion criteria
Exclusion criteria
for participating parents or caregivers:
Exclusion criteria
for participating children:
Exclusion criteria
for facilitators:
Exclusion criteria
for community development officers
The programme addresses main challenges of Parenting and builds skills in 4 main areas
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (17 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (13 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (13 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Perpetration of intimate partner violence (parent-report) will be measured using adapted versions of the Revised Conflict Tactics Scale Short Form (6 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Intimate partner violence victimisation (parent-report) will be measured using adapted versions of the Revised Conflict Tactics Scale Short Form (6 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Partner conflict will be assesses using a Revised Conflict Tactics Short Form based on two items assessing dysfunctional adult relationships in the household (e.g., "Your parents/carers or any other adults in your household quarrelled or had verbal arguments with each other").
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child physical abuse will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (7 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child physical will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (5 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child physical will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (5 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child emotional abuse will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (10 items, ICAST-Trial)
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child emotional abuse will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (8 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child emotional abuse will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (8 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child neglect will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (2 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child neglect will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (4 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Children's experience of physical and sexual violence in the community in the past month will be based on one item (e.g., "In the past month, how often did adults in your community such as teachers, employer religious or community leaders, neighbours and other adults kick, punch, beat or threaten you with a knife or any other weapon physically?". Responses will be based on a Likert scale ranging from 0=Never to 3=Often.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child sexual abuse will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (10 items, ICAST-Trial).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Intimate partner coercion perpetration (parent-report) will be measured using an adapted version of the WHO questionnaire on women's health and life events.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Intimate partner coercion victimisation (parent-report) will be measured using an adapted version of the WHO questionnaire on women's health and life events
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Psychological aggression (parent-report) will be measured an adapted version of the Revised Conflict Tactics Scale Short Form (2 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Psychological aggression victimisation (parent-report) will be measured using an adapted version of the Revised Conflict Tactics Scale Short Form (2 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Physical aggression perpetration (parent-report) will be measured using an adapted version of the Revised Conflict Tactics Scale Short Form (4 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Physical aggression victimisation (parent-report) will be measured using an adapted version of the Revised Conflict Tactics Scale Short Form (4 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Physical aggression perpetration (parent-report) will be measured using an adapted version of the Revised Conflict Tactics Scale Short Form (2 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Intimate partner sexual violence victimisation (parent-report) will be measured an adapted version of the Revised Conflict Tactics Scale Short Form (2 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Attitudes toward punishment will be assessed using two items based on the UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Attitudes toward punishment will be assessed using one item from the UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Partner negotiation will be based on four items adapted from the Revised Conflict Tactics Scale Short Form (9 items; CTS2S).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Positive partner relationships witnessed by children will be based on one item (e.g., "In the past month, how often did your parent figures in your household say nice things to each other in your presence?").
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Positive parenting will be assessed using 10 items adapted from the Alabama Parenting Questionnaire (APQ-SF).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Positive parenting will be assessed using 20 items adapted from the Alabama Parenting Questionnaire (APQ-SF).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Parental monitoring will be assessed using 6 items adapted from the Alabama Parenting Questionnaire (APQ-SF)
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Parental monitoring will be assessed using 10 items adapted from the Alabama Parenting Questionnaire (APQ-SF).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational aspirations will be measured by one item asking the parent, "How far would you like your child to go in school?" rated on a 5-point scale
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational aspirations will be measured by one item asking the child, "How far would you like to go in school?" rated on a 5-point scale
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational expectations will be measured using one item asking the parent how far they think their child will actually go in school rated on the same 5-point scale.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational expectations will be measured using one item asking the child how far they think they will actually go in school rated on the same 5-point scale.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational re-enrolment will be assessed for children who are not currently in school by asking parents whether or not they would want them to go back to school. (0=No, 1=Yes)
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Educational re-enrolment will be assessed for children who are not currently in school by asking children whether or not they would want to go back to school (0=No, 1=Yes).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Parental support for school will be measured by asking how often the parent engages in behaviours that support learning using a 5-point Likert scale
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Parental support for school will be measured by asking how often the child's male and female parent figures engage in behaviours that support learning using a 5-point Likert scale.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child behaviour problems will be measured using the Child and Adolescent Behaviour Inventory (CABI). 0 = Not True; 1 = Somewhat or Sometimes true; 2 = Very True; 999=Refused to answer; 888=Not Applicable. 19 items
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child behaviour problems will be measured using the Child and Adolescent Behaviour Inventory (CABI). 0 = Not True; 1 = Somewhat or Sometimes true; 2 = Very True; 999=Refused to answer; 19 items.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child substance use will be measured using two items based on lifetime alcohol and tobacco consumption (e.g. "Have often do you drink alcohol?"). Responses will be based on a 4-point Likert scale of 0 to 3 (0=Never; 3=Often).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child prosocial behaviour will be assessed from items derived from the pre-post study of PfR (5 items; e.g."Your child is considerate of other people's feelings.").
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child prosocial behaviour will be assessed from items derived from the pre-post study of PfR (5 items; e.g., "You are considerate of other people's feelings.")
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Respectful behaviour by children will be assessed by asking parents one question about how often they see their children behaving well.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Gender socialisation of children will be assessed based on asking parents whether they agree or disagree about a series of statements regarding gender roles.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Gender socialisation of children will be assessed based on asking children whether they agree or disagree about a series of statements regarding gender roles.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Respectability will be assessed by asking parents two questions regarding their attitudes to parental responsibilities regarding respectability.
Time frame: Baseline, 8-months post-baseline, and 12-months post-baseline
Respectability will be assessed by asking children eight questions regarding parental behaviour enforcing and modelling respectability.
Time frame: Baseline, 8-months post-baseline, and 12-months post-baseline
Parenting stress (parent-report) will be based on a reduced version of the Parenting Stress Scale (9 items; PSS).
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Adult depression (parent-report) will be measured using the depression subscale from the Depression, Anxiety, and Stress Scale.e,g. "How often in the past week, have you felt sad or down?").
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Adult experience of violence during childhood will be assessed using 6 items covering a range of childhood exposure to violence.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Communication about sexual behaviour by parents will be assessed by asking caregivers whether or not they have engaged in conversations with their children about puberty and sexual reproductive health.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
Child report of communication about sexual behaviour by parents will be assessed by asking caregivers whether or not their male and female parent figures have engaged in conversations with them about puberty and sexual reproductive health.
Time frame: Baseline, 8-months post-baseline and 12-months post-baseline
The impact of COVID-19 will be assessed by asking parents to indicate whether they have been stressed by Covid-19, whether the child has been affected by Covid-19 and where the spouse relationship has been affected by Covid-19 agree.
Time frame: Baseline
Adult experience of violence during childhood will be assessed using 6 items covering a range of childhood exposure to violence, including witnessing partner conflict to experiencing corporal punishment and sexual abuse.
Time frame: Baseline
Relative poverty will be assessed using an adapted version of the Basic Necessities Scale (6 items). Developed by the Centre for South African Social Policy in the 'Indicators of Poverty and Social Exclusion Project.
Time frame: Baseline
Relative poverty will be assessed using an adapted version of the Basic Necessities Scale (6 items). Developed by the Centre for South African Social Policy in the 'Indicators of Poverty and Social Exclusion Project.
Time frame: Baseline
Family stressors will be based on six items measuring the presence or absence of the following challenging situations in each household.
Time frame: Baseline
Food insecurity will be assessed by asking adult respondents to report on whether their household was able to provide meals at breakfast, lunch, and dinner in the past month based on a Likert scale (0 =No; 1=Yes, sometimes; 2=Yes, always).
Time frame: Baseline
Food insecurity will be assessed by asking child respondents to report on whether their household was able to provide meals at breakfast, lunch, and dinner in the past month based on a Likert scale (0 =No; 1=Yes, sometimes; 2=Yes, always).
Time frame: Baseline
Basic caregiver and child demographic information will be asked using items from the UNICEF Multiple Indicators Cluster Survey (MICS) Household Survey.
Time frame: 8-months post-baseline
Recruitment rate will be based on the number of families who were eligible for inclusion and provided consent to participate in the program divided by the number of target population who were exposed to recruitment activities.
Time frame: 8-months post-baseline
Enrolment rate will be based on the number of families who attend either at least one session of Parenting for Respectability or the Parenting in a Nutshell lecture divided by the number of families allocated to either study arm.
Time frame: 8-months post-baseline
Participation rates for those allocated to the PfR programme will be mean attendance rate for programme sessions based on those families who enrolled in the programme.
Time frame: 8-months post-baseline
Dropout rates for enrolled participants will be defined as the percentage of participants who fail to attend at least three consecutive sessions and do not attend any sessions at a later stage.
Time frame: 8-months post-baseline
Completion rates for participants will be determined based on the number of enrolled participants who attend a cut-off threshold of at least 62.5% of the programme (i.e., 10 sessions)
Time frame: 8-months post-baseline
Facilitators will report on the start and end time of each session/lecture in their weekly reports. Implementation dosage will be based on the total amount of time delivered divided by the mean attendance rate.
Time frame: 8-months post-baseline
Time cost for delivery will be collected from facilitator weekly reports and based on the time spent on training, preparation, travel to and from, and delivery of each session/lecture.
Time frame: 8-months post-baseline
Implementation fidelity by programme facilitators of the PfR programme will be examined using self-report checklists by the programme facilitators.
Time frame: 8-months post-baseline
Competent adherence will be assessed using the PfR Facilitator Assessment Tool (PfR-FAT).
Time frame: 8-months post-baseline, 12-months post-baseline
In-depth interviews with senior implementation staff (N=4)
Time frame: 8-months post-baseline, 12-months post-baseline
The researchers will have Focus group discussions with caregivers (N=8, 10 per FGD).
Time frame: 8-months post-baseline, 12-months post-baseline
Data will be collected through semi-structured interviews with Wakiso and Amuru District Community Development Services (N=4)
Time frame: 8-months post-baseline, 12-months post-baseline
Programme costs will be calculated using a micro-costing approach.
Makerere University
Other
Acronym: UPRISE
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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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