Clinical trial NCT05105373: Implementation Science and Impact Evaluation of PfR Programme: A Hybrid cRCT Design
Official title: Implementation Science and Impact Evaluation of PfR Programme: A Hybrid cRCT Design
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parenting
Gender-based Violence
Child Maltreatment
IPV
Lead sponsor: Makerere University
Sponsor class: OTHER
Collaborators: name: University of Glasgow
name: Oak Foundation
name: Network of European Foundations
name: University of Oxford
First posted: 2021-11-03
Enrollment: 3162
Sex: ALL
Minimum age (years): 1
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Trial Hybrid Type 2 Evaluation
Primary purpose: PREVENTION

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: Inclusion criteria for participating parents or caregivers:

1. Age 18 or older;
2. Primary caregiver responsible for the care of a child between the ages of 10 and 14;
3. Agreement to participate in the PfR programme if allocated to the treatment condition;
4. Provision of consent to participate in the full study.

Inclusion criteria for participating children:

1. Age 10 to 14 years;
2. Live in the same household as primary caregiver who is part of PfR study;
3. Parent/caregiver gives consent to participate in the study;
4. Provision of consent to participate in the full study.

Inclusion criteria for facilitators:

1. Age 18 or older;
2. Facilitator who is involved in the delivery of the Parenting for Respectability programme;
3. Provision of consent to participate in the full study.

inclusion criteria for community development officers

1. Age 18 or older;
2. Involvement in delivery of PfR, or existing leadership role in communities where PfR is delivered;
3. Provision of consent to participate in the full study.

Exclusion Criteria:

Exclusion criteria for participating parents or caregivers:

1. Below Age 18;
2. Not a Primary caregiver responsible for the care of a child between the ages of 10 and 14;
3. Does not Provide consent to participate in the full study.

Exclusion criteria for participating children:

1. Below Age 10 and above age 14
2. Does not Live in the same household as primary caregiver who is part of PfR study;
3. Parent/caregiver does not gives consent to participate in the study;

Exclusion criteria for facilitators:

1. Below age 18;
2. Facilitator who is Not involved in the delivery of the Parenting for Respectability programme;
3. Does not Provide consent to participate in the full study.

Exclusion criteria for community development officers

1. Below age 18;
2. Is not Involved in the delivery of PfR, or has no existing leadership role in communities where PfR is delivered;
3. Does not provide consent to participate in the full study

Primary outcomes:
measure: Assessing a Change in Child maltreatment - physical and emotional abuse; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child maltreatment - physical and emotional abuse; Child Report on Male Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child maltreatment - physical and emotional abuse; Child Report on Female Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner violence - perpetration; Parent-report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner violence -victimisation; Parent-report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Partner conflict; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
Secondary outcomes:
measure: Assessing a Change in Child physical abuse-Parent report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child physical abuse; Child Report on Male Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child physical abuse; Child Report on Female Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child emotional abuse; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child emotional abuse; Child Report on Male Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child emotional abuse; Child Report on Female Parent Figure
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child neglect; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child neglect; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Community physical and sexual violence; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child sexual abuse; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner coercion- perpetration; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner coercion - victimisation; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner psychological aggression - perpetration; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner psychological aggression - victimisation; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner physical aggression - perpetration; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner physical aggression - victimisation; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner sexual violence - perpetration; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Intimate partner sexual violence - victimisation; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Attitudes toward punishment; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Attitudes toward punishment; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Partner negotiation; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Positive partner relationships; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Positive parenting; Adult Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Positive parenting; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Parental monitoring; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Parental monitoring; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Educational aspirations; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Educational aspirations; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Educational expectations; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Educational expectations; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Educational re-enrolment; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Educational re-enrolment; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Parent support of education; Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Parent support of education; Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child behaviour problems; Adult Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child behaviour problems: Child and Adolescent Behaviour Inventory - Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child substance use - Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child prosocial behaviour - Adult Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child prosocial behaviour - Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Child respectful behaviour - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Gender socialisation - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Gender socialisation - Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Respectability - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Respectability - Child Report
timeFrame: Baseline, 8-months post-baseline, and 12-months post-baseline
measure: Assessing a Change in Parenting stress - Parent Report
timeFrame: Baseline, 8-months post-baseline, and 12-months post-baseline
measure: Assessing a Change in Adult depression - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Adult experience of violence during childhood - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Communication about Sexual Behaviour - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Communication about Sexual Behaviour - Child Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
measure: Assessing a Change in Impact of COVID-19 - Parent Report
timeFrame: Baseline, 8-months post-baseline and 12-months post-baseline
Other outcomes:
measure: Adult experience of violence during childhood - Parent Report
timeFrame: Baseline
measure: Basic childhood necessities - Parent Report
timeFrame: Baseline
measure: Basic childhood necessities - Child Report
timeFrame: Baseline
measure: Family stressors - Parent Report
timeFrame: Baseline
measure: Food insecurity - Adult Report
timeFrame: Baseline
measure: Food insecurity - Child Report
timeFrame: Baseline
measure: Basic caregiver and child demographic information - Child and Adult Report
timeFrame: Baseline
measure: Recruitment rate - Assessor Report
timeFrame: 8-months post-baseline
measure: Enrolment rate - Facilitator Report
timeFrame: 8-months post-baseline
measure: Participation rate - Parenting for Respectability participants only - Facilitator Report
timeFrame: 8-months post-baseline
measure: Dropout rate - Facilitator Report
timeFrame: 8-months post-baseline
measure: Completion rate - Facilitator Report
timeFrame: 8-months post-baseline
measure: Implementation dosage (time) - Facilitator Report
timeFrame: 8-months post-baseline
measure: Time cost for delivery - Facilitator Report
timeFrame: 8-months post-baseline
measure: Implementation fidelity - Facilitator Report
timeFrame: 8-months post-baseline
measure: Competent adherence - Observational
timeFrame: 8-months post-baseline
measure: Qualitative Outcomes - In-depth Interviews
timeFrame: 8-months post-baseline, 12-months post-baseline
measure: Qualitative Outcomes - Focus Group Discussions
timeFrame: 8-months post-baseline, 12-months post-baseline
measure: Qualitative Outcomes - Semi Structured Interviews
timeFrame: 8-months post-baseline, 12-months post-baseline
measure: Cost effectiveness data collection
timeFrame: 8-months post-baseline, 12-months post-baseline
Locations:
city: Kampala
country: Uganda
facility: Wakiso Busukuma and Amuru Lamogi subcounties
Study officials:
affiliation: Child Health and Development Centre, Makerere University
name: Dr. Godfrey Siu, PHD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Glasgow: MRC/CSO Social and Public Health Sciences Unit
name: Dr. Jamie M. Lachman, D.PHIL
role: PRINCIPAL_INVESTIGATOR
References: