NCT04809272

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
522

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 8, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 15, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 22, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

November 1, 2022

Enrollment Period

9 months

First QC Date

March 15, 2021

Last Update Submit

November 1, 2022

Conditions

Keywords

Parenting programmeChild physical and emotional abuse

Outcome Measures

Primary Outcomes (4)

  • Child maltreatment - physical abuse and emotional abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICAST-TP) - Physical and Emotional Abuse Subscales

    Physical abuse (including abusive discipline), emotional abuse, and neglect will be measured using 4 items from reduced version of the ISPCAN Child Abuse Screening Tool-Trial Parent version (ICAST-TP). The ICAST-TP measures parental reports of the incidence of abuse perpetrated against their child over the past month using a frequency score on a scale of 0 to 7, or 8 or more times (e.g., "In the past 4 weeks, how often did you discipline \[Child Nickname\] by spanking, slapping, or hitting with your hand?"). This study will assess frequency of child maltreatment for physical abuse (2 items) and emotional abuse (2 items), as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse).

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • Child maltreatment - physical abuse and emotional abuse: Frequency of overall abuse

    We will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale.

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • Positive parenting: Parent Daily Report Checklist

    Two items adapted from the Parent Daily Report (PDR) will be used to assess positive parenting \[19\] at baseline, post-test, and every week during programme delivery. Parents will report about their behaviour within the past week instead of the past 24 hours. The two items are "how many times in the past week did you and your child do something fun together?" and "how many times in the past week did you praise your child for doing well?" The items will be rated on a frequency scale of 0 to 7, or 8 or more times.

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • Parenting stress: Parent Daily Report Checklist

    One item adapted from the Parent Daily Report (PDR) will be used to assess parenting stress \[19\] at baseline, post-test, and every week during programme delivery. Parents will report about their behaviour within the past week instead of the past 24 hours. The item asks, "how many times in the past week did you feel very stressed as a parent/caregiver?" The items will be rated on a frequency scale of 0 to 7, or 8 or more times.

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

Secondary Outcomes (10)

  • Child maltreatment - physical abuse and emotional abuse: Fortnightly Assessments

    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)

  • Positive parenting: Fortnightly Assessments

    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)

  • Parenting Stress: Fortnightly Assessments

    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)

  • Child behaviour problems: Child and Adolescent Behaviour Inventory (CAPI) - Parent Report

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • Child behaviour problems: Three Problem Rating Scale - Parent Report

    Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • +5 more secondary outcomes

Other Outcomes (12)

  • Sociodemographic information: UNICEF Multiple Indicators Cluster Survey (MICS) Household Survey

    Baseline

  • COVID-19 information: Parent Report

    Baseline

  • Implementation Fidelity: Facilitator check-lists

    Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)

  • +9 more other outcomes

Study Arms (1)

ParentChat for parents of children ages 2-17

EXPERIMENTAL

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). 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. 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.

Behavioral: ParentChat for parents of children ages 2-17

Interventions

The programme will include text/audio messages, illustrated comics, videos, and activity assignments for parents to do with their children. Parents will be prompted to give feedback regarding successes and challenges applying these parenting skills via audio or text messages during the week.

ParentChat for parents of children ages 2-17

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Oxford

Oxford, Oxfordshire, OX1 2ER, United Kingdom

Location

Study Officials

  • Jamie M. Lachman, DPhil

    University of Oxford

    PRINCIPAL INVESTIGATOR
  • Rumaya Juhari, PhD

    University Putra Malaysia

    PRINCIPAL INVESTIGATOR
  • Galina Lesco, PhD

    Health for Youth Association, Moldova

    PRINCIPAL INVESTIGATOR
  • Ida Ferdinandi, PhD

    UNICEF Montenegro

    PRINCIPAL INVESTIGATOR
  • Marija Raleva, PhD

    Alternativa

    PRINCIPAL INVESTIGATOR
  • Rosanne Jocson, PhD

    Ateneo de Manila University

    PRINCIPAL INVESTIGATOR
  • Kufre Okop, PhD

    University of Cape Town

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: This is a pre-post study with assessments at baseline and immediate post-intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2021

First Posted

March 22, 2021

Study Start

March 8, 2021

Primary Completion

December 1, 2021

Study Completion

June 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Anonymised data will be shared on Open Science Framework after the completion of the study and results are published

Shared Documents
STUDY PROTOCOL
Time Frame
Indefinitely
Access Criteria
Accessibility of the data will require approval from the study team. The study investigators, led by the PI, will jointly make decisions on whether to supply research data to potential new users. Research data will be deposited in and available in the UK Data Archive solely for non-profit use.

Locations