Clinical trial NCT04809272: ePLH Pilot Study: Online Support Parent Groups - ParentChat
Official title: COVID-19 e-Parenting for Lifelong Health (ePLH) Pilot Study: Promoting Positive Parenting and Preventing Violence Through Online Parent Support Groups - ParentChat
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: Universiti Putra Malaysia
name: Health for Youth Association, Moldova
name: Ateneo de Manila University
name: UNICEF Montenegro
name: Alternativa
name: University of Cape Town
First posted: 2021-03-22
Enrollment: 522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a pre-post study with assessments at baseline and immediate post-intervention.
Primary purpose: PREVENTION

Brief summary: Pilot trial：

The feasibility study of the programme modules has a pre-post design with no control group, with the aims of assessing programme implementation, cultural and contextual relevance, and study feasibility. Although there will be no comparison group and it is not designed to test effects, the study also has a provisional goal of reductions in child physical and emotional abuse at immediate post-intervention.

Pre-post design:

The ePLH parent support groups will be delivered over a 8 week period (i.e., 7-8 short online interactive group sessions, two per week). The programme will include text/audio messages, illustrated comics, videos, and activity assignments for parents to do with their children. ePLH facilitators will moderate discussions around the parenting theme, support parents on an individual basis, and encourage them to apply the parenting skills at home. Parents will be prompted to give feedback regarding successes and challenges applying these parenting skills via audio or text messages during the week. The facilitators will begin the next group engagement with a brief voice summary of the feedback and address possible solutions to 2-3 key challenges. Facilitators will also be provided with weekly supervision by an ePLH coach or trainer. A designated research assistant will provide parent support groups with needed technical support during the implementation - including IT-related support. Data bundles will be provided for internet access and to incentivise engagement.

Detailed description: Recruitment of six countries:

This study will use targeted/purposive sampling to recruit participating parents or caregivers (n = 30-100 in Malaysia, Moldova, Montenegro, North Macedonia and Philippines; 400 in South Africa). Groups will start to operate after at least 7 members have been consented and can have up to 15 members per group.

Malaysia: The National Population and Family Development Board (LPPKN) is our partner organisation for both the Semarak Kasih Parenting Program (2018-2020) and e-Semarak Kasih / ParentChat. A total of 24 staff of LPPKN have been trained for the Semarak Kasih Parenting Program, of which, 12 of them have conducted the actual program. The majority of these facilitators are University graduates holding various posts at LPPKN such as counsellors, Information Officers and Community Development Officers.

Moldova: The Health for Youth Association, has been implementing PLH for children 2-9 years in the country, in cooperation with Youth Klinics network. In Moldova, the program will be focused on caregivers/parents of adolescents (10-17 years old). The Moldovan research team will identify potential eligible parents to invite to participate in ParentChat through a) social media pages (FB, OK) of the Youth Klinics network, b) through the announcement of different partners organizations that work in social support area, and c) through the communication with YK consultants who work with parents of adolescents.

Montenegro: In Montenegro, trained facilitators from our implementing partners (health centres, kindergartens and NGOs) will recruit families by applying the same strategies used for face-to-face PLH:

* Inviting potential participants on the waiting lists for face-to-face PLH,
* Advertising on social media (the Oxford team may advertise as well if partners seek support),
* Inviting families known to service providers (e.g. parents of children attending the participating preschools, parents using psychological/mental counselling at health centres, parents users of NGO led services such as single parent support groups and the like).

North Macedonia: The Institute Alternativa - Institute for Marriage, Family and Systemic Practice has been implementing PLH for children 2-9 years in the country. The Institute Alternativa has identified potential eligible parents through the FB page of the Institute, and also those who have contacted the Institute Counselling Telephone line during the COVID-19 pandemic and expressed readiness to participate in an online programme. The psychologists who work on this help line will provide the research team with a list of eligible participants with children ages 2 to 17 years. There are already approximately 70 parents that expressed interest, of which 50 will be randomly selected for initial recruitment.

Philippines: The research team will work closely with the Department of Social Welfare and Development (DSWD) staff to identify potential eligible parents who are recipients of the conditional cash transfer program (4Ps). 4Ps staff will provide the research team with a list of eligible participants with children ages 2 to 17 years, of which 50 will be randomly selected for initial recruitment. If less than 50 of the selected participants provide consent and are eligible, the remaining adults will be randomly selected from the original list until the full target sample size is reached.

South Africa: Recruitment of programme facilitators will be done from the already trained pool of PLH facilitators in South Africa with the support of Clowns Without Borders (CWBSA). The South Africa research team and implementing team will recruit and train 10 facilitators consisting of two trained PLH trainers/Coaches from CWBSA, and 8 moderators (persons experienced in PLH implementation) who will each run 1 PSG. The two facilitators from CWBSA will also play a mentoring role for the other facilitator/moderators. The rest of the other 8 moderators will be sourced from various organisations and individuals that have been trained in PLH programmes (both PLH Kids and PLH Teens) in 5 of South Africa's provinces. For the ParentChat (Caregivers) groups, the moderators will conduct the recruitment of parents/caregivers telephonically or by one-on-one visit. This will be done from their communities where they work. Initial contact will be made with a few caregivers, who may then refer others to the group. Each group would have about 8-12 caregivers. 1000 families are expected to be reached.

Eligibility criteria: Inclusion criteria for participating parents or caregivers (n = 30-100 in Malaysia, Moldova, Montenegro, North Macedonia and Philippines; 500 in South Africa):

* Any person over the age of 18 years currently caring for child between the ages of 2 to 17 years
* Has regular contact with the child and spends time with the child at least two times a week
* Has access to a smartphone and is willing to join an online parenting support group to share, learn and discuss parenting
* Has provided consent to participate in the study

Inclusion criteria for facilitator and moderator (n = 10 per country):

* Age 18 or older
* Prior participation in a facilitator or moderator training workshop
* Agreement to implement the entire programme
* Provision of consent to participate in the full study

Exclusion criteria for parents or caregivers and for facilitators and moderators:

* Children below 18 years old
* Those who do not give consent to participate in the research.

Primary outcomes:
measure: Child maltreatment - physical abuse and emotional abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICAST-TP) - Physical and Emotional Abuse Subscales
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Child maltreatment - physical abuse and emotional abuse: Frequency of overall abuse
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Positive parenting: Parent Daily Report Checklist
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Parenting stress: Parent Daily Report Checklist
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Secondary outcomes:
measure: Child maltreatment - physical abuse and emotional abuse: Fortnightly Assessments
timeFrame: Change between T0 (baseline), T2 (2 weeks), T4 (4 weeks), T6 (6 weeks), T8 (8 weeks) and post-test at T10 (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Positive parenting: Fortnightly Assessments
timeFrame: Change between T0 (baseline), T2 (2 weeks), T4 (4 weeks), T6 (6 weeks), T8 (8 weeks) and post-test at T10 (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Parenting Stress: Fortnightly Assessments
timeFrame: Change between T0 (baseline), T2 (2 weeks), T4 (4 weeks), T6 (6 weeks), T8 (8 weeks) and post-test at T10 (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Child behaviour problems: Child and Adolescent Behaviour Inventory (CAPI) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Child behaviour problems: Three Problem Rating Scale - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Sexual abuse risk: Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Attitude toward punishment: Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Parent well-being: Depression, Anxiety, and Stress Scale (DASS) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Parent exposure to IPV and intimate partner coercion: WHO Multi-Country Questionnaire on Women's Health and Domestic Violence against Women (WHO) - Parent Report
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Parent exposure to IPV and intimate partner coercion: Revised Conflict Tactics Scale Short Form (CTS2S)
timeFrame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Other outcomes:
measure: Sociodemographic information: UNICEF Multiple Indicators Cluster Survey (MICS) Household Survey
timeFrame: Baseline
measure: COVID-19 information: Parent Report
timeFrame: Baseline
measure: Implementation Fidelity: Facilitator check-lists
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Programme Adherence - Enrolment rates: Attendance registration
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Programme Adherence - Mean attendance rates: Attendance registration
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Programme Adherence - Dropout rates: Attendance registration
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Participant satisfaction: Parent overall satisfaction
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Facilitator and participant engagement: Process monitor reports
timeFrame: Once per week over 8 week during programme delivery
measure: Acceptability - Participants' observed change in parent-child relationships at home during programme: Focus groups
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Acceptability - Cultural acceptability and appropriateness of programme materials, delivery, and key programme components: Focus groups
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Acceptability - Existing barriers to participation during sessions and engagement in home practice and other activities: Interviews
timeFrame: Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
measure: Feasibility of Programme for scale-up: Weekly facilitator survey - Facilitator Report
timeFrame: Once per week over 8 week during programme 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
affiliation: University Putra Malaysia
name: Rumaya Juhari, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Health for Youth Association, Moldova
name: Galina Lesco, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNICEF Montenegro
name: Ida Ferdinandi, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Alternativa
name: Marija Raleva, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ateneo de Manila University
name: Rosanne Jocson, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Kufre Okop, PhD
role: PRINCIPAL_INVESTIGATOR
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