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Trial registered on ANZCTR


Registration number
ACTRN12622001156774
Ethics application status
Approved
Date submitted
21/07/2022
Date registered
24/08/2022
Date last updated
24/08/2022
Date data sharing statement initially provided
24/08/2022
Date results information initially provided
24/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
Parenting for life long health: Assessing the feasibility, acceptability, implementation aspects and outcomes of an adapted parenting course for parents in North India
Scientific title
Parenting for life long health: Assessing the feasibility, acceptability, implementation aspects and outcomes of an adapted parenting course for parents in North India
Secondary ID [1] 307548 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Child abuse 326981 0
Poor parenting 326982 0
Low resilience 326983 0
Gender discrimination 326984 0
Poor mental health 326985 0
Condition category
Condition code
Mental Health 324175 324175 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Parenting for Lifelong Health (PLH) for adolescents is an intervention designed and developed in South Africa, for parents and adolescents from the age of 13 to 18 years. This intervention is an evidence based program on parenting principles such as parent teen communication and parent teen problem solving for risks inside and outside homes. The intervention has 14 modules which were adapted for the Indian context, in consultation with an Experts by Experience group, and called 'Parwarish'.

Parwarish seeks to reduce harsh parenting and violence within families through new attitudes and skill building between parents and adolescents. Module content includes spending quality time together, communicating positively, managing strong emotions such as anger and finding safe support when needed as well as problem-solving, conflict resolution and finance skills, including how to manage a household budget and uses role-plays, activity-based learning and home rehearsal and activities building on social learning.

Parwarish was implemented by the Emmanuel Hospital Association (EHA) Community Health and Development Programme teams based in Agra, Robertsganj (Uttar Pradesh - UP) and Khunti (Jharkhand). A coach was appointed and trained face to face for each location and took responsibility for recruiting facilitators as well as training and coaching facilitators. Trainers from PLH-Teens South Africa facilitated a 10-day face to face course for Parwarish facilitators, and a 3-day face to face training for coaches (total n=25 participants) less than 2 months before the start of the intervention. The facilitators were then coached/trained face to face once every two weeks by the coaches.
The facilitators then led the 14 Parwarish modules over 14 - 18 weeks with groups of 10 - 15 parent-teens dyads, with meetings of 1.5 to two hours and encouraged participants to complete the weekly activity to try at home using a hard copy home-work booklet specifically designed for this intervention E.g., family eats dinner together. Home visits by facilitators, with those who missed a session to review the topic for the week, included a summary of the discussion topic and encouragement to attend the next session and was not more than 30 minutes for each visit.
In each site, a local ‘coach’ supported facilitators with weekly meetings during the intervention, reflecting on their facilitation while a fortnightly coach-the-coaches meeting was led online with someone from PLH-Teens South Africa.
Implementation of Parwarish groups was conducted by pairs of community facilitators with the following criteria for facilitation selection:
Parents of adolescents who were resident in the target community.
Represent an equal mix of genders willing to work as a pair in facilitation (over half of facilitators worked as a married couple).
Trusted and accepted as a leader by the community.
Effective communicators.
Had at least passed class 10th and were fluent in the local dialect or language.

Quality of implementation (adherence to training) was monitored using attendance and checklists filled by coaches and facilitators (summarised below). Separately, a project officer at each location was responsible for research components of the project and supported baseline and endline data collection as well as monitoring and evaluation of Parwarish sessions with other EHA community coordinators in the team. Coaches filled a paper register at each site on the following measures for monitoring adherence to intervention:
• Facilitation and fidelity: 14 of 14 sessions self-reported by facilitators using a 5-point checklist where a score of 1 indicated Poor quality and a score of 5 indicated High quality. The following components of the intervention were assessed with this scale: physical exercise, emotional check in, main teaching topic, role play and completion of home activity.
• Facilitation and fidelity: 4 of 14 sessions for each Parwarish group were observed and measured by the coach, EHA project manager or a researcher who had all been trained to fill using the same criteria. Fidelity assessed the five aspects above and two additional aspects, namely: facilitator engagement, and completion of registers.
• Attendance of facilitators and coaches at trainings and coaching: attendance register.
• Attendance of parents and adolescents: attendance register
• Completion of assigned home activities: register.
• Home visits completed by facilitators: register.
Intervention code [1] 324005 0
Prevention
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331984 0
Any change in positive and harsh parenting assessed by subscales from the Alabama Parenting Questionnaire
Timepoint [1] 331984 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Primary outcome [2] 331985 0
Any change in parental monitoring assessed by subscales from the Alabama Parenting Questionnaire
Timepoint [2] 331985 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Primary outcome [3] 331986 0
Any change in adolescent behavioral problems assessed by Strengths and Difficulties Questionnaire
Timepoint [3] 331986 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [1] 411811 0
Any change in discipline methods used by parents assessed by ISPCAN Child Abuse screening tool
Timepoint [1] 411811 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [2] 411812 0
Any change in the use of corporal punishment assessed by ISPCAN Child Abuse screening tool
Timepoint [2] 411812 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [3] 411813 0
Any change in depression assessed by Patient Health Questionnaire 9 (PHQ9)
Timepoint [3] 411813 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [4] 411814 0
Any change in gender views and attitudes assessed by Gender Attitudes scale (GEMS)
Timepoint [4] 411814 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [5] 411815 0
Any change in adolescent resilience to adversity assessed by Child Youth Resilience Measure (CYRM)
Timepoint [5] 411815 0
18 weeks after starting the course (immediately after completion of the 14 modules of Parwarish)
Secondary outcome [6] 412590 0
Acceptability and feasibility of the Parwarish program using a paper register at each site on the following measures:
• Facilitation and fidelity: 14 of 14 sessions self-reported by facilitators using a 5-point checklist where a score of 1 indicated Poor quality and a score of 5 indicated High quality. The following components of the intervention were assessed with this scale: physical exercise, emotional check in, main teaching topic, role play and completion of home activity.
• Facilitation and fidelity: 4 of 14 sessions for each Parwarish group were observed and measured by the coach, EHA project manager or a researcher who had all been trained to fill using the same criteria. Fidelity assessed the five aspects above and two additional aspects, namely: facilitator engagement, and completion of registers.
• Attendance of facilitators and coaches at trainings and coaching: attendance register.
• Attendance of parents and adolescents: attendance register
• Completion of assigned home activities: register.
• Home visits completed by facilitators: register.

These components will be analysed together as a composite outcome to indicate the acceptability and feasibility of the study.
Timepoint [6] 412590 0
During the 18 weeks of intervention

Eligibility
Key inclusion criteria
Young people and their parents resident in target areas of EHA Community Health and Development Programme teams based in Agra, Robertsganj (UP) and Khunti (Jharkhand).
Aged 13 - 18 years
Minimum age
13 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Young people and families not residing in the area for the ensuing 15 weeks.

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Pre-post uncontrolled study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Basic descriptive statistics and t-test to determine significant change in mean scores. Regression analysis.
The qualitative data was analysed using thematic analysis to manually code and group data into themes (Braun and Clarke 2006) to better understand the acceptability, feasibility and implementation aspects of the parenting intervention.
Realist evaluation was done to understand context and mechanism linked to outcomes

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
15/04/2019
Date of last participant enrolment
Anticipated
Actual
1/06/2019
Date of last data collection
Anticipated
Actual
31/12/2019
Sample size
Target
115
Accrual to date
Final
239
Recruitment outside Australia
Country [1] 24890 0
India
State/province [1] 24890 0
Uttar Pradesh and Jharkhand

Funding & Sponsors
Funding source category [1] 311821 0
Hospital
Name [1] 311821 0
Herbertpur Christian Hospital
Country [1] 311821 0
India
Primary sponsor type
Individual
Name
Kaaren Mathias
Address
University of Canterbury
20 Kirkwood Avenue, Upper Riccarton, Christchurch 8041
NZ
Country
New Zealand
Secondary sponsor category [1] 313296 0
Individual
Name [1] 313296 0
Pooja S Pillai
Address [1] 313296 0
Herbertpur Christian Hospital, Emmanuel Hospital Association,
Athan Bagh, Herbertpur, Uttarakhand 248142
Country [1] 313296 0
India

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311265 0
Emmanuel Hospital Association Institutional Ethics Committee
Ethics committee address [1] 311265 0
808/92 Deepali Building, Nehru place, New Delhi, 110019
Ethics committee country [1] 311265 0
India
Date submitted for ethics approval [1] 311265 0
01/11/2018
Approval date [1] 311265 0
10/01/2019
Ethics approval number [1] 311265 0
Protocol 191

Summary
Brief summary
This parwarish intervention has 14 modules on parenting, which were adapted for the Indian context, in consultation with an Experts by Experience group. Parwarish seeks to reduce harsh parenting and violence within families through new attitudes and skill building between parents and adolescents. Parwarish was implemented by the EHA Community Health and Development Programme teams based in Agra, Robertsganj (UP) and Khunti (Jharkhand).

Our hypothesis was; Does the parenting intervention developed by WHO (parenting for lifelong Health; PLH - adolescents) lead to better outcomes for parents and adolescents in resource poor settings in North India?
The overall aim of the study was to assess the acceptability, feasibility, implementation aspects and outcomes of a parenting intervention for parents of adolescents aged 13 to 18 years in urban slums of North India.
Trial website
Trial related presentations / publications

Public notes
Process evaluation has been published with the following reference: Mathias K, Nayak P, Singh P, et al Is the Parwarish parenting intervention feasible and relevant for young people and parents in diverse settings in India? A mixed methods process evaluation
BMJ Open 2022;12:e054553. doi: 10.1136/bmjopen-2021-054553

Contacts
Principal investigator
Name 120502 0
Mrs Pooja S Pillai
Address 120502 0
Herbertpur christian Hospital,
Athan Bagh, Herbertpur, Dehradun, 248142
Country 120502 0
India
Phone 120502 0
+917300836960
Fax 120502 0
Email 120502 0
poojas.burans@gmail.com
Contact person for public queries
Name 120503 0
Mrs Pooja S Pillai
Address 120503 0
Herbertpur christian Hospital,
Athan Bagh, Herbertpur, Dehradun, 248142
Country 120503 0
India
Phone 120503 0
+917300836960
Fax 120503 0
Email 120503 0
poojas.burans@gmail.com
Contact person for scientific queries
Name 120504 0
Dr Kaaren Mathias
Address 120504 0
University of Canterbury, School of health sciences, Arts road, 8041
Christchurch, New Zealand
Country 120504 0
New Zealand
Phone 120504 0
+642041497530
Fax 120504 0
Email 120504 0
kaaren.mathias@canterbury.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Sensitive data pertaining to mental health status cannot be shared and needs to maintain confidentiality.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16697Ethical approval    384361-(Uploaded-20-07-2022-17-05-47)-Study-related document.pdf
16699OtherMathias K, Nayak P, Singh P, et al, Is the Parwarish parenting intervention feasible and relevant for young people and parents in diverse settings in India? A mixed methods process evaluationBMJ Open 2022;12:e054553. doi: 10.1136/bmjopen-2021-054553   384361-(Uploaded-20-07-2022-18-31-32)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.