PLH for Teens - Hybrid Delivery

Child Maltreatment Clinical Trial

Official title:

Parenting for Lifelong Health for Teens - Hybrid Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05071924
• Other study ID #: PLH/M2M/HY21
• Status: Completed
• Phase: N/A
• Start date: July 5, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: November 2022
• Source: University of Oxford
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1128
• Est. completion date: June 1, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Child Maltreatment
• Positive Parenting

Intervention

Behavioral:
• PLH Teens Original: In-person PLH programme for parents and teens by community-based workers
This in-person intervention is delivered over 14 sessions (10 joint parent and teen sessions and 4 separate parent and teen sessions).
• PLH Teens Hybrid: Hybrid delivery for parents and teens by facilitators
The hybrid intervention delivered over 12 sessions (8 sessions delivered via WhatsApp groups to parents only and 4 sessions delivered in-person to parents and teens together).

Locations

Country	Name	City	State
United Kingdom	University of Oxford	Oxford	Oxfordshire

Sponsors (3)

Lead Sponsor	Collaborator
University of Oxford	Mothers2Mothers, University of Cape Town

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Demographics: Demographic Survey - Parent Report	Basic demographic information will be collected at baseline and post-test for caregivers. Demographic information will include; age, gender, literacy, family structure and dynamics, and risk behaviours. During screening family risk will also be assessed using a Vulnerability assessment tool as a proxy assessment of vulnerability to understand the socio-economic needs of respondents (USAID, 2012). There are six questions that will be asked to respondents which are drawn from the topic of child protection, access to education, nutrition status, child's care and support, child social behaviour, and access to health. Each question will either be in a form of Likert or multiple choice question and have a maximum score of 4. Higher total score indicates lower vulnerability.	Baseline
Other	Demographics: Demographic Survey - Teen Report	Basic demographic information will be collected at baseline and post-test for teens. Demographic information will include; age, gender, literacy, family structure and dynamics, and risk behaviours. During screening family risk will also be assessed using a Vulnerability assessment tool as a proxy assessment of vulnerability to understand the socio-economic needs of respondents (USAID, 2012). There are six questions that will be asked to respondents which are drawn from the topic of child protection, access to education, nutrition status, child's care and support, child social behaviour, and access to health. Each question will either be in a form of Likert or multiple choice question and have a maximum score of 4. Higher total score indicates lower vulnerability.	Baseline
Other	Enrolment Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report	Facilitator programme adherence will be assessed by examining rates of enrolment.	Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Other	Attendance Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report	Facilitator programme adherence will be assessed by examining rates of attendance.	Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Other	Dropout Rates of Participant Engagement: Weekly Facilitator Survey - Facilitator Report	Facilitator programme adherence will be assessed by examining rates of dropout. Dropout rates for enrolled participants will be defined as the percentage of participants who do not attend at least two consecutive sessions across either the in-person or online components of the programme, and do not attend any sessions at a later stage.	Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Other	Implementation Fidelity: Facilitator Report	Implementation fidelity of the hybrid PLH programme will be measured using self-report checklists by facilitators to understand the extent to which core intervention components are delivered. These checklists will include specific activities for each session in both the in-person and at home components of the programme. Then, in order to produce a basic level of fidelity, a ratio of programme implementation to programme design will be created for the self-report scores. A score of 80% programme fidelity will be considered as "high treatment fidelity".	Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Other	Intervention Cost of Programme for Scale-up: Facilitator Report	Intervention cost of programme for scale-up will be assessed using facilitator reports of the time and resource costs spent delivering the programme. This will include training and preparation for delivery.	Weekly from week 1- 12 for hybrid delivery and week 1-14 for in-person delivery
Primary	Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Parent Report	Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Parent respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.	Change between Baseline and Post (approx. 4 months post-baseline)
Primary	Child Maltreatment: ISPCAN Child Abuse Screening Tools-Trial Version - Teen Report	Child maltreatment will be assessed using a shortened version of the ISPCAN Child Abuse Screening Tools-Trial Version (9-item subscale ICAST-T). Teen respondents will be asked to indicate the frequency of emotional and physical discipline practices over the past month using a 9-point frequency count scale (0 = never; 8 = 8 or more times). Items include, "In the past 4 weeks, how often did you/your caregiver discipline your child/you by spanking, slapping or hitting with a hand?" and "In the past 4 weeks, how often did you/your caregiver shout, yell or scream at you?" In the past 4 weeks, how often did you/your caregiver discipline your child/you with an object like a stick or a belt?". Items are summed, with higher scores indicating greater use of harsh parenting.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Parenting Stress: Parenting Stress Scale	Parenting Stress will be assessed using the Parenting Stress Scale (7-item PSS subscale; Berry & Jones, 1995). The PSS asks parents to respond to items related to positive (e.g., "I feel close to my child") and negative (e.g., "I feel overwhelmed by the responsibility of being a parent") feelings related to parenting stress using a 5-point Likert-like scale (1 = Strongly disagree; 5 = Strongly agree). After reverse-coding certain items, items will be summed with higher scores indicating higher levels of parenting stress.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Child Maltreatment - Physical Abuse and Emotional Abuse: ISPCAN Child Abuse Screening Tool-Intervention (ICASTTP) - Physical and Emotional Abuse Subscales	Physical abuse and emotional abuse will be measured using 4 items from a 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 your child by spanking, slapping, or hitting with your hand?").	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Positive Parenting: Alabama Parenting Questionnaire - Parent Report	Positive parenting will be assessed based on parent-report of an adapted version of the Alabama Parenting Questionnaire (6-item APQ subscale; Frick, 1991). The APQ measures the frequency of specific behaviours towards children in the past month on a 7-point Likert-like scale (e.g., "You talk to your child about their friends"; 0 = never; 6 = always). Items are summed to create a frequency score, with higher scores indicating more regular use of positive parenting.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Positive Parenting: Alabama Parenting Questionnaire - Teen Report	Positive parenting will be assessed based on teen-report of an adapted version of the Alabama Parenting Questionnaire (6-item APQ subscale; Frick, 1991). The APQ measures the frequency of specific behaviours towards children in the past month on a 7-point Likert-like scale (e.g., "Your caregiver talks to you about your friends"; 0 = never; 6 = always). Items are summed to create a frequency score, with higher scores indicating more regular use of positive parenting.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Child Behaviour Problems: Strengths and Difficulties Questionnaire - Parent Report	Child behaviour problems will be assessed using parent-report of the Strengths and Difficulties Questionnaire (10-item SDQ; Goodman, 1997). Respondents will be asked to report on the frequency of specific child behaviours (e.g., "Your child is restless, overactive, cannot stay still for long" using a 3-point Likert-like scale (1 = Not true; 3 = Very true). Items are summed, with higher scores indicating more behavioural problems.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Child Behaviour Problems: Strengths and Difficulties Questionnaire - Teen Report	Child behaviour problems will be assessed using teen-report of the Strengths and Difficulties Questionnaire (10-item SDQ; Goodman, 1997). Respondents will be asked to report on the frequency of specific child behaviours (e.g., "You are restless, overactive, cannot stay still for long" using a 3-point Likert-like scale (1 = Not true; 3 = Very true). Items are summed, with higher scores indicating more behavioural problems.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Parental Depression: Centre for Epidemiologic Studies Depression Scale - Parent Report	Parental depression will be assessed using the Centre for Epidemiologic Studies Depression Scale (10-item CES-D subscale; Radloff, 1977). Caregivers will be asked to respond to items related to how they have felt over the past seven days (e.g., "How often in the past week have you been bothered by things that don't usually bother you?"). Responses are coded on a 4-point Likert-like scale (i.e., 1 = Rarely or none of the time (less than 1 day) to 4 = Most or all of the time (5 to 7 days)) and summed to create a total of parental depression.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Teens Internalising Behaviours: Strength and Difficulties Questionnaire (SDQ) - Parent Report	Teen internalising behaviours will be assessed using parent-report of the Strengths and Difficulties Questionnaire (SDQ) based subscales for emotional problems (e.g. "I worry a lot") and peer problems (e.g. "I am usually on my own. I generally play alone or keep to myself") (15-item SDQ subscale; Goodman, 1997). Items are summed to create a total measurement of internalising behaviour.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Risk Avoidance: Risk Avoidance Planning Scale - Parent Report	Risk Avoidance will be assessed using parent-report of the Risk Avoidance Planning Scale (5-item RAPS; Cluver et al., 2018). Caregivers will be asked whether they have spoken to their child about risks in the community including topics such as safe sex and community safety. This scale was developed specifically for the PLH for Teens programme in South Africa (Cluver et al., 2018). Caregivers will be asked to respond on a 3-point Likert-like scale as to whether they have spoken to their child about risks in the community (1 = No, I find it too hard to talk about this; 2 = We haven't made plans yet but I would like to talk about it; 3 = We have made a plan together). Topics will include safe sex and community safety.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Risk Avoidance: Risk Avoidance Planning Scale - Teen Report	Risk Avoidance will be assessed using teen-report of the Risk Avoidance Planning Scale (5-item RAPS; Cluver et al., 2018). Teens will be asked to respond on a 3-point Likert-like scale as to whether they have spoken about risks in the community (1 = No, I find it too hard to talk about this; 2= We haven't made plans yet but I would like to talk about it; 3 = We have made a plan together). Topics will include safe sex and community safety.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Economic Strengthening: Family Financial Coping Scale - Parent Report	Economic Strengthening will be measured using a Family Financial Coping Scale (5-item FFCS; Lown, 2011). Caregivers will be asked to respond to household demographic items over the past month. These items cover a variety of financial matters including whether caregivers were worried about money, whether they managed to save money, and whether they ran out of money to buy certain items, including food, transport, and mobile data or airtime. Responses are coded on a 4-point Likert scale (0 = Never, 1 = Rarely, 2 = Sometimes, 3= Often). Items are summed, with a higher score reflected a greater number of financial challenges.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Economic Strengthening: Family Financial Coping Scale - Teen Report	Economic Strengthening will be measured using a Family Financial Coping Scale (5-item FFCS; Lown, 2011). Teens will be asked to respond to household demographic items over the past month. These items cover a variety of financial matters including whether caregivers were worried about money, whether they managed to save money, and whether they ran out of money to buy certain items, including food, transport, and mobile data or airtime. Responses are coded on a 4-point Likert scale (0 = Never, 1 = Rarely, 2 = Sometimes, 3= Often). Items are summed, with a higher score reflected a greater number of financial challenges.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Parent Support of Education: Parental Support for School Scale - Parent Report	Parent Support of Education will be measured using an adapted version of the Parental Support for School Scale (6-item PSE; Ceballo, Maurizi, Suarez, & Aretakis, 2014). Caregivers will report on the frequency of supportive behaviour towards children's learning (e.g. "I support my child's schoolwork in any way that I can" and "I praise my child for working hard at school") using a 5-point Likert-like scale (1 = never; 5 = always). Items are summed to create a frequency score, with higher scores suggesting more parental support and value for school. Items from this survey are present in both the parent survey.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Parent Support of Education: Parental Support for School Scale - Teen Report	Parent Support of Education will be measured using an adapted version of the Parental Support for School Scale (6-item PSE; Ceballo, Maurizi, Suarez, & Aretakis, 2014). Teens will report on the frequency of supportive behaviour towards children's learning (e.g. "support your schoolwork in any way that he/she can" and "praise you for working hard at school") using a 5-point Likert-like scale (1 = never; 5 = always). Items are summed to create a frequency score, with higher scores suggesting more parental support and value for school. Items from this survey are present in the teen survey.	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Teen Report	Attitude toward punishment will be measured using a single-item from the UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module - Teen Report (1-item; ). Teens will be asked to report on whether they agree or disagree with the statement: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished".	Change between Baseline and Post (approx. 4 months post-baseline)
Secondary	Attitude Toward Punishment: UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline Module - Parent Report	Attitude toward punishment will be measured using a single-item from the UNICEF Multiple Indicator Cluster Survey (MICS) 5 Child Discipline module - Teen Report (1-item; ). Caregivers will be asked to report on whether they agree or disagree with the statement: "In order to bring up, raise up, or educate a child properly, the child needs to be physically punished".	Change between Baseline and Post (approx. 4 months post-baseline)