Child MaltreatmentePLHNCT04809272
ePLH Pilot Study: Online Support Parent Groups - ParentChat
A study testing ParentChat for parents of children ages 2-17 in people with Child Maltreatment and Positive Parenting, run by University of Oxford at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Child Maltreatment, Positive Parenting
- What is being tested?
- ParentChat for parents of children ages 2-17
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 522 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 8 Mar 2021to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: COVID-19 e-Parenting for Lifelong Health (ePLH) Pilot Study: Promoting Positive Parenting and Preventing Violence Through Online Parent Support Groups - ParentChat
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.
Read more
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.
Read the 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.
- Conditions
- Child Maltreatment, Positive Parenting
- Being tested
- ParentChat for parents of children ages 2-17
- Keywords
- Parenting programme, Child physical and emotional abuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ParentChat for parents of children ages 2-17Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: ParentChat for parents of children ages 2-17 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
The fortnightly assessments will include a brief survey of the 7 items on primary outcomes asking parents/caregivers about how many times they engaged in positive parenting, physical and emotional abuse, and experience of parenting stress in the past 2 weeks.
Measured: 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
The fortnightly assessments will include a brief survey of the 7 items on primary outcomes asking parents/caregivers about how many times they engaged in positive parenting, physical and emotional abuse, and experience of parenting stress in the past 2 weeks.
Measured: 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
The weekly assessments will include a brief survey of the 7 items on primary outcomes asking parents/caregivers about how many times they engaged in positive parenting, physical and emotional abuse, and experience of parenting stress in the past 2 weeks.
Measured: 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
Child behaviour problems will be measured using the Child and Adolescent Behaviour Inventory (CABI). The CABI assesses a wide range of internalizing and externalizing symptoms in children and adolescents and is relatively shorter than the Child Behaviour Check List (CBCL), making it a practical and reliable tool for measuring behaviour problems. Parents report on their child's behaviour during the past week. The irritability subscale and the externalizing subscale will be used to measure problem behaviours. Items on both subscales are summed to create a total score of child behaviour problems.
Measured: 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
2 items adapted from the Three Problem Scale-Parent Report will be used to assess whether specific concerns or issues parents are having with their children change during an intervention. Parents report whether the behaviour has occurred in the past week and select the most problematic behaviour from the list of 10 and indicate how challenging the behaviour was on a scale of 0 to 8 (0 = not a problem, 8 = could not be worse).
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Sexual abuse risk: Parent Report
One item will be used to assess parents' perceptions of reduction of sexual abuse risk. The item asks, "how confident do you feel you are to protect your child from sexual abuse online or in-person?" Parents/primary caregivers will respond based on an 8-point Likert scale of 0 to 4 (0 = Not confident at all; 8 = Extremely confident).
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Attitude toward punishment: Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module - Parent Report
Attitudes toward punishment will be assessed using one item from the UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module. The MICS item asks the parent/primary caregiver: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished." Parents/primary caregivers will report whether they disagree or agree with the statement.
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent well-being: Depression, Anxiety, and Stress Scale (DASS) - Parent Report
The depression subscale of the Depression, Anxiety, and Stress Scale (DASS) will assess caregiver well-being. The DASS is a 21-item scale used as a screening tool to measure depression, anxiety, and stress in adults. The stress subscale includes 7 items (e.g., ""I felt down-hearted and sad"). Caregivers report on the frequency of depressive symptoms in the previous week using a Likert scale (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always).
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent exposure to IPV and intimate partner coercion: WHO Multi-Country Questionnaire on Women's Health and Domestic Violence against Women (WHO) - Parent Report
Adult self-report of experiencing intimate partner violence and coercion over the past week will be assessed using 2 items from an adapted version of the Revised Conflict Tactics Scale Short Form (CTS2S). The CTS2S scale includes 2 items on the frequency of physical assault ("partner pushed, shoved, or slapped me"), and psychological aggression ("partner insulted, shouted, yelled, or swore at me"). All answers are coded on a frequency scale of 0 to 7, or 8 or more times. Alternatively, caregivers will indicate whether they experienced violence from a partner (e.g., hitting, pushing or slapping; insulting, shouting or yelling) in the past week by answering yes or no.
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent exposure to IPV and intimate partner coercion: Revised Conflict Tactics Scale Short Form (CTS2S)
Adult self-report of experiencing intimate partner violence and coercion over the past week will be assessed using 2 items from adapted items from the WHO Multi-Country Study Questionnaire on Women's Health and Life and Domestic Violence against Women (WHO). The adapted WHO questionnaire includes 2 items on coercion and emotional violence ("my partner insisted on knowing where I was at all times"), and on restriction of financial autonomy (e.g., "my partner refused to give me money for household expenses, even when he/she had money for other things."). All answers are coded on a frequency scale of 0 to 7, or 8 or more times. Alternatively, caregivers will indicate whether they experienced violence from a partner (e.g., hitting, pushing or slapping; insulting, shouting or yelling) in the past week by answering yes or no.
Measured: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2021
- Study start8 Mar 2021
- Primary completion1 Dec 2021
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Child MaltreatmentStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a pre-post study with assessments at baseline and immediate post-intervention.
- Masking
- None (open label)
- Enrolment
- 522 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Collaborators
- Universiti Putra Malaysia, Health for Youth Association, Moldova, Ateneo de Manila University, UNICEF Montenegro, Alternativa, University of Cape Town
- Responsible party
- Principal investigator, DrJamieLachman, University of Oxford
- Investigators
- Jamie M. Lachman, DPhil, Principal investigator, University of OxfordRumaya Juhari, PhD, Principal investigator, Universiti Putra MalaysiaGalina Lesco, PhD, Principal investigator, Health for Youth Association, MoldovaIda Ferdinandi, PhD, Principal investigator, UNICEF MontenegroMarija Raleva, PhD, Principal investigator, AlternativaRosanne Jocson, PhD, Principal investigator, Ateneo de Manila UniversityKufre Okop, PhD, Principal investigator, University of Cape Town
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04809272
- Sponsor's protocol ID
- R72537/RE001
- Acronym
- ePLH
- Status last verified
- Nov 2022
- First submitted
- 15 Mar 2021
- Last updated
- 2 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Anonymised data will be shared on Open Science Framework after the completion of the study and results are published
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 e-Parenting for Lifelong Health (ePLH) Pilot Study: Promoting Positive Parenting and Preventing Violence Through Online Parent Support Groups - ParentChat
- ClinicalTrials.gov ID
- NCT04809272
- Acronym / sponsor ID
- ePLH / R72537/RE001
- Conditions
- Child Maltreatment, Positive Parenting
- Keywords
- Parenting programme, Child physical and emotional abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 522 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Collaborators
- Universiti Putra Malaysia, Health for Youth Association, Moldova, Ateneo de Manila University, UNICEF Montenegro, Alternativa, University of Cape Town
- Study start
- 8 Mar 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 22 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a pre-post study with assessments at baseline and immediate post-intervention.
| Arm | Type | Receives |
|---|---|---|
| ParentChat for parents of children ages 2-17 | Experimental | Behavioral: ParentChat for parents of children ages 2-17The 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ParentChat for parents of children ages 2-17The 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. | Behavioural | ParentChat for parents of children ages 2-17 |
Primary outcome
Child maltreatment - physical abuse and emotional abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICAST-TP) - Physical and Emotional Abuse Subscales
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
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).
Child maltreatment - physical abuse and emotional abuse: Frequency of overall abuse
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
We will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale.
Positive parenting: Parent Daily Report Checklist
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
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.
Parenting stress: Parent Daily Report Checklist
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
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.
10 secondary outcomes
Child maltreatment - physical abuse and emotional abuse: Fortnightly Assessments
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Sexual abuse risk: Parent Report
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Attitude toward punishment: Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module - Parent Report
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent well-being: Depression, Anxiety, and Stress Scale (DASS) - Parent Report
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent exposure to IPV and intimate partner coercion: WHO Multi-Country Questionnaire on Women's Health and Domestic Violence against Women (WHO) - Parent Report
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Parent exposure to IPV and intimate partner coercion: Revised Conflict Tactics Scale Short Form (CTS2S)
Time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: Yes. Anonymised data will be shared on Open Science Framework after the completion of the study and results are published
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jamie M. Lachman, DPhil principal investigator
University of Oxford
Rumaya Juhari, PhD principal investigator
Universiti Putra Malaysia
Galina Lesco, PhD principal investigator
Health for Youth Association, Moldova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ParentChat for parents of children ages 2-17 in people with Child Maltreatment and Positive Parenting, run by University of Oxford at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child maltreatment - physical abuse and emotional abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICAST-TP) - Physical and Emotional Abuse Subscales (time frame: Change between Baseline and Post (approx. 1 month after end of intervention, i.e., 3 months post pre-assessment)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2022.