Implementation Science and Impact Evaluation of PfR Programme: A Hybrid cRCT Design

NCT05105373 | Completed

• 1 other identifier: Uprise2021
• Study Type: interventional
• Target: 3,162
• Locations: 1 country
• Sites: 1

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).

Conditions

Parenting; Gender-based Violence; Child Maltreatment; IPV

Outcome Measures

Primary Outcomes (6)

• Assessing a Change in Child maltreatment - physical and emotional abuse; Parent Report

  Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (17 items, ICAST-Trial).

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child maltreatment - physical and emotional abuse; Child Report on Male Parent Figure

  Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (13 items, ICAST-Trial).

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child maltreatment - physical and emotional abuse; Child Report on Female Parent Figure

  Child maltreatment will be measured using an adapted version of the ISPCAN Child Abuse Screening Tool-Trial scale (13 items, ICAST-Trial).

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Intimate partner violence - perpetration; Parent-report

  Perpetration of intimate partner violence (parent-report) will be measured using adapted versions of the Revised Conflict Tactics Scale Short Form (6 items; CTS2S).

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Intimate partner violence -victimisation; Parent-report

  Intimate partner violence victimisation (parent-report) will be measured using adapted versions of the Revised Conflict Tactics Scale Short Form (6 items; CTS2S).

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Partner conflict; Child Report

  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").

  Baseline, 8-months post-baseline and 12-months post-baseline

Secondary Outcomes (50)

• Assessing a Change in Child physical abuse-Parent report

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child physical abuse; Child Report on Male Parent Figure

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child physical abuse; Child Report on Female Parent Figure

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child emotional abuse; Parent Report

  Baseline, 8-months post-baseline and 12-months post-baseline

• Assessing a Change in Child emotional abuse; Child Report on Male Parent Figure

  Baseline, 8-months post-baseline and 12-months post-baseline

Other Outcomes (20)

• Adult experience of violence during childhood - Parent Report

  Baseline

• Basic childhood necessities - Parent Report

  Baseline

• Basic childhood necessities - Child Report

  Baseline

Study Arms (2)

Intervention-Parenting for Respectability

EXPERIMENTAL

Randomisation in the cRCT will be conducted at the cluster level. PfR is a 16-session manualised programme starting with nine single sex sessions followed by seven mixed sex sessions, delivered once a week by two local facilitators who receive one week's training. Activities were developed specifically for PfR or adapted from other parenting programs, including Project H, Stepping Stones, Mema kwa Jamii, The International Child Development Programme and Parenting for Lifelong Health. The programme addresses four familial processes associated with GBV and VAC: poor parental bonding and child attachment; harsh parenting; inequitable socialisation by gender and parental conflict. A particular goal is to involve fathers, whom most parenting programmes find hard to recruit, and the first nine sessions are delivered in single-sex groups.

Behavioral: Parenting for Respectability

Control-Parenting for Respectability in a nutshell

ACTIVE COMPARATOR

Randomisation in the cRCT will be conducted at the cluster level immediately after baseline data collection. Parents allocated to the control arm will receive a two-hour structured lecture called Parenting in a Nutshell on parenting and partner relationships. Three topics will be covered: 1) child development; 2) positive parenting; and 3) resolving partner conflicts. Facilitators delivering this lecture will have same/similar expertise with the facilitators engaged in PfR. .

Behavioral: Parenting for Respectability

Interventions

Parenting for Respectability BEHAVIORAL

The programme addresses main challenges of Parenting and builds skills in 4 main areas 1. Poor parental bonding and child attachment; 2. Harsh parenting 3. Inequitable socialisation by gender 4. Parental conflict.

Control-Parenting for Respectability in a nutshell; Intervention-Parenting for Respectability

Eligibility Criteria

• Age: 1 Year - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older;
• Primary caregiver responsible for the care of a child between the ages of 10 and 14;
• Agreement to participate in the PfR programme if allocated to the treatment condition;
• Provision of consent to participate in the full study.
• Age 10 to 14 years;
• Live in the same household as primary caregiver who is part of PfR study;
• Parent/caregiver gives consent to participate in the study;
• Provision of consent to participate in the full study.
• Age 18 or older;
• Facilitator who is involved in the delivery of the Parenting for Respectability programme;
• Provision of consent to participate in the full study.
• Age 18 or older;
• Involvement in delivery of PfR, or existing leadership role in communities where PfR is delivered;
• Provision of consent to participate in the full study.

You may not qualify if:

• Below Age 18;
• Not a Primary caregiver responsible for the care of a child between the ages of 10 and 14;
• Does not Provide consent to participate in the full study.
• Below Age 10 and above age 14
• Does not Live in the same household as primary caregiver who is part of PfR study;
• Parent/caregiver does not gives consent to participate in the study;
• Below age 18;
• Facilitator who is Not involved in the delivery of the Parenting for Respectability programme;
• Does not Provide consent to participate in the full study.
• Below age 18;
• Is not Involved in the delivery of PfR, or has no existing leadership role in communities where PfR is delivered;
• Does not provide consent to participate in the full study

Sponsors & Collaborators

• Makerere University: lead
• University of Glasgow: collaborator
• Oak Foundation: collaborator
• Network of European Foundations: collaborator
• University of Oxford: collaborator

Study Sites (1)

Wakiso Busukuma and Amuru Lamogi subcounties

Kampala, Uganda

Location

Study Officials

• Dr. Godfrey Siu, PHD

  Child Health and Development Centre, Makerere University

  PRINCIPAL INVESTIGATOR

• Dr. Jamie M. Lachman, D.PHIL

  University of Glasgow: MRC/CSO Social and Public Health Sciences Unit

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The allocation status of other participating families will be concealed from participants, thus reducing the potential for contamination. Research assistants conducting data assessments and statisticians conducting analysis will be blind to allocation in order to minimise assessment bias. Different groups of research assistants will be employed for outcome assessments and monitoring of implementation fidelity and adherence. Any instances of compromised blinding will be immediately reported. In the case of instances of harm or severe abuse being reported by a participant at any stage of the study, the allocation status of the participant will be un-blinded. All cases of un-blinding will be reported. Because of facilitators' involvement in the programme implementation, blinding will not be possible for service providers. Similarly, of course, participants cannot be blind to their own treatment condition.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Controlled Trial Hybrid Type 2 Evaluation

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: November 3, 2021
• Study Start: August 6, 2021
• Primary Completion: August 31, 2022
• Study Completion: December 30, 2022
• Last Updated: December 4, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

UG (1)