Clinical trial NCT05071924: PLH for Teens - Hybrid Delivery
Official title: Parenting for Lifelong Health for Teens - Hybrid Delivery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Maltreatment
Positive Parenting
Keywords: Parenting programme
Child physical and emotional abuse
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Mothers2Mothers
name: University of Cape Town
First posted: 2021-10-08
Enrollment: 1128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a pre-post study with assessments at baseline and immediate post- intervention.
Primary purpose: PREVENTION

Brief summary: This study aims to examine the implementation and effectiveness of the original version of PLH Teens delivered in-person (PLH Teens-Original) and a hybrid in-person and remote delivery of the programme (PLH Teens-Hybrid) as part of the Mothers2Mothers' (M2M) Children and Adolescents are My Priority (CHAMP) project in Mpumalanga, South Africa. It will also examine differential effects between PLH Teens-Original and PLH Teens-Hybrid on reducing risks of violence against children using propensity score matching. Lastly, it will examine the implementation feasibility of PLH Teens-Hybrid in terms of implementation fidelity; recruitment, retention, and engagement of parents and adolescents; and the relevance, acceptability, and satisfaction of the programme.

Detailed description: Study Design This study will use a mixed-methods approach to qualitatively and quantitatively address the research aims. It will be implemented from May to July 2021 in the Mpumalanga province of South Africa. The study design will involve a) pre-post quantitative analyses of primary and secondary outcomes for both PLH Teens-Original and PLH Teens-Hybrid, b) difference in analyses to compare effects between the two delivery modalities, and c) qualitative interviews and quantitative analyses of programme feasibility and implementation.

Recruitment Recruitment of parents/caregivers and adolescents will be integrated into CHAMP's current recruitment strategy which includes engaging with schools, faith-based organisations, local NGOs, health facilities, United States Agency for International Development (USAID) DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored, and Safe) partners, door-to-door engagement and other contextually relevant approaches. CHAMP leverages its partnerships for recruitment and the CHAMP partner, Grassroots Soccer, actively engages in recruitment for the DREAMS programme. Participants enrolled into the hybrid PLH programme will be screened using the USAID approved Vulnerability Assessment Tool to ensure that the most vulnerable households are reached. The pilot will target caregivers in the Nelspruit area to ensure adequate access to internet connectivity.

Eligibility criteria: Inclusion criteria for participating parents or caregivers:

* Any person over the age of 18 currently caring for a child between the ages of 10 and 17
* Has the ability to attend the in-person parenting support group (PLH Teens-Original)
* Has access to a WhatsApp compatible smartphone and is willing to join an online parenting support group (PLH Teens-Hybrid)
* Has provided consent to participate in the study

Inclusion criteria for teens:

* Must be between the age of 10 and 17
* Has a parent or caregiver who is participating in the programme
* Parent has provided consent to participate in the study
* Has provided assent to participate in the study

Inclusion criteria for facilitators:

* The facilitator must be over the age of 18
* Has completed a facilitator training workshop specifically for the PLH-Teens hybrid delivery prior to intervention delivery
* Is able to access the in-person session location
* Has a smart-phone or device capable of delivering the programme via an online platform such as WhatsApp or Viber
* Has provided informed consent to participate in the study

Primary outcomes:
measure: Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
Secondary outcomes:
measure: Parenting Stress: Parenting Stress Scale
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Child Maltreatment - Physical Abuse and Emotional Abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICASTTP) - Physical and Emotional Abuse Subscales
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Positive Parenting: Alabama Parenting Questionnaire - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Positive Parenting: Alabama Parenting Questionnaire - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Child Behaviour Problems: Strengths and Difficulties Questionnaire - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Child Behaviour Problems: Strengths and Difficulties Questionnaire - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Parental Depression: Centre for Epidemiologic Studies Depression Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Teens Internalising Behaviours: Strength and Difficulties Questionnaire (SDQ) - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Risk Avoidance: Risk Avoidance Planning Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Risk Avoidance: Risk Avoidance Planning Scale - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Economic Strengthening: Family Financial Coping Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Economic Strengthening: Family Financial Coping Scale - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Parent Support of Education: Parental Support for School Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Parent Support of Education: Parental Support for School Scale - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Teen Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
measure: Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Parent Report
timeFrame: Change between Baseline and Post (approx. 4 months post-baseline)
Other outcomes:
measure: Demographics: Demographic Survey - Parent Report
timeFrame: Baseline
measure: Demographics: Demographic Survey - Teen Report
timeFrame: Baseline
measure: Enrolment Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report
timeFrame: Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
measure: Attendance Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report
timeFrame: Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
measure: Dropout Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report
timeFrame: Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
measure: Implementation Fidelity: Facilitator Report
timeFrame: Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
measure: Intervention Cost of Programme for Scale-up: Facilitator Report
timeFrame: Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Locations:
city: Oxford
country: United Kingdom
facility: University of Oxford
state: Oxfordshire
Study officials:
affiliation: University of Oxford
name: Jamie M. Lachman, DPhil
role: PRINCIPAL_INVESTIGATOR
References: