Ignite Creation Date:
2024-05-06 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04721730
Status:
COMPLETED
Last Update Posted:
2022-03-22
First Post:
2021-01-13
Brief Title:
Prevention of Child Mental Health Problems in Southeastern Europe - Phase 3
Sponsor:
University of Bremen
Organization:
University of Bremen
Study Overview
Official Title:
Prevention of Child Mental Health Problems in Southeastern Europe - Adapt Optimize Test and Extend Parenting for Lifelong Health - RISE - The Randomized Controlled Trial Phase 3 of MOST
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RISE
Brief Summary:
The overall RISE project aims to adapt optimise and test a low-cost parenting programme for families in three southeastern European countries North Macedonia Republic of Moldova Romania Therefore the investigators apply the Multiphase Optimization Strategy MOST and conduct the study over 3 phases during the first Phase Preparation the feasibility of the intervention and the assessment and implementation procedures were tested in a small pilot study In the second Phase Optimization 8 different programme combinations were tested in order to identify the most effective and cost-effective combination in the three countries Now in the third Phase Evaluation the optimised intervention identified in Phase 2 will be tested in a randomised controlled trial The investigators also apply dimensions of the RE-AIM framework to maximise the reach effectiveness adoption implementation within the existing service infrastructure and maintained use of the new intervention
For the current Phase 3 the investigators aim to recruit a total of 864 parents n 288 per country of children with elevated child behaviour problems aged 2 to 9 years After pre-assessment the families will be randomly assigned to the intervention group or the control group Parents in the intervention group will receive a parenting programme 5 sessions Parenting for Lifelong Health for Young Children PLH-YC and the parents in the control condition will receive one lecture on parenting Raising Healthy Children Parents will be asked to complete assessments after intervention completion post-assessment and 12 months after pre-assessment follow-up assessment in order to detect immediate and more longterm effects
For the current Phase 3 the investigators aim to recruit a total of 864 parents n 288 per country of children with elevated child behaviour problems aged 2 to 9 years After pre-assessment the families will be randomly assigned to the intervention group or the control group Parents in the intervention group will receive a parenting programme 5 sessions Parenting for Lifelong Health for Young Children PLH-YC and the parents in the control condition will receive one lecture on parenting Raising Healthy Children Parents will be asked to complete assessments after intervention completion post-assessment and 12 months after pre-assessment follow-up assessment in order to detect immediate and more longterm effects
Detailed Description:
Over the past decade there have been increasing calls for the scale-up of evidence-based interventions in order to reduce the risk of violence against children in low- and middle-income countries LMICs In particular group-based parenting programmes for families with young children have been shown to be effective in reducing the risk of child maltreatment and improving child wellbeing with promising evidence emerging from low- and middle-income countries These group-based programmes typically aim to strengthen caregiver-child relationships through positive parenting and help parents to manage child behaviour problems through effective age-appropriate nonviolent discipline strategies
Despite the emerging evidence of the effectiveness of parenting interventions in reducing violence against children many local governments and service providers in LMICs face multiple challenges in implementing evidence-based parenting programmes in resource poor contexts Parenting programmes are often too expensive to deliver effectively at scale in low-resource settings due to their complexity intensity and length Parenting programmes developed and evaluated in other contexts also may not fit the local service delivery context and may require adaptation to be relevant to the local culture of families Additional programme content may also be necessary to address acute economic deprivation high community violence and parental distress The process of delivery may also need to be simplified to improve participant engagement and the quality of delivery
As a result it is essential that programmes implemented in LMICs are
Effective at reducing violence against children
Integrated within the existing service delivery system of the country
Feasible and culturally acceptable to service providers and families and
Scalable in terms of their affordability replicability and sustainability while reaching a maximum number of beneficiaries
However there are currently very few parenting programmes that meet these criteria in LMICs such as North Macedonia Republic of Moldova and Romania where the need is the greatest
The Parenting for Lifelong Health PLH initiative is focused on the development evaluation and dissemination of parenting programmes to reduce violence against children and improve child wellbeing in LMIC It was established to address the need to develop low-cost evidence-based parenting programmes that can be integrated within existing service delivery systems in LMIC The PLH for Young Children from 2-9 y PLH-YC programme includes general content like one-on-one timechild-led play praising and rewarding children instructions household rules and routines managing difficult behaviours ignore and consequences reflection and moving on Core activities during sessions include group discussions illustrated vignettes role-plays collaborative problem solving practicing skills at home
The overall RISE project has two general objectives 1 the first objective relates to the adaption optimisation and evaluation of selected best practice intervention condition MOST while 2 the second objective relates to implementation issues RE-AIM
The primary objective of the overall project is adapt optimise and test a parenting programme so that it meets the specific needs and constraints of families in three LMIC in Southeastern Europe The design is informed by the Multiphase Optimisation Strategy MOST and is conduced over 3 distinct phases 1 Preparation 2 Optimisation and 3 Evaluation In Phase 1 the feasibility of the intervention and research methods was tested in a small pilot study in North Macedonia Republic of Moldova and Romania In Phase 2 8 different programme components were tested in a factorial experiment to identify the most effective and cost-effective combination In the present Phase 3 the optimised intervention identified in Phase 2 will be tested in a randomised-controlled trial
A secondary objective of this project is to carefully assess barriers to implementation integration with existing service delivery systems and scale-ups from the outset to facilitate sustainability and real world applicability at the end of the project When introducing such an innovative intervention in resource-limited settings it is important to focus on the implementation processes that increase reach efficacy adoption and sustainability of culturally-adapted and optimized versions of the programme in addition to evaluating programme effectiveness The theoretical model for the implementation framework in the RISE project is RE-AIM Reach Efficacy Adoption Implementation Maintenance Glasgow et al 2011 As a result investigators will examine the adoption defined as the proportion of settings willing to initiate the intervention reach the proportion of eligible individuals that participate in the intervention and implementation the fidelity adherence dosage assessed with multiple measures as well as on effectiveness and sustainability of the RISE project at the organizational and participants level In addition it will be examined how implementation factors influence programme effectiveness and how potential population characteristics might affect outcomes eg moderators such as baseline parent mental health for details see study protocol Taut et al in preparation
The first two Phases have been successfully completed For details of Phase 1 see trial registration httpsclinicaltrialsgovct2showNCT03552250 and study protocol doi 101136bmjopen-2018-026684 For details of Phase 2 please refer to the trial registration httpsclinicaltrialsgovct2showNCT03865485 or the study protocol httpsdoiorg101016jcct2019105855
This presently registered study relates to the Evaluation Phase Phase 3 This randomised-controlled trial ist to test the effectiveness and the cost-effectiveness of the optimised intervention identified in the factorial experiment Phase 2 in the three LMIC North Macedonia Republic of Moldova and Romania More details can be found in the study protocol for Phase 3
Note The investigators have developed a stepwise safety plan in case the local restrictions due to COVID-19 pandemic will not allow in-person assessments and parent groups as planned The safety plan includes the reduction of the number of parents per group size switch to online delivery of PLH-YC and lecture phone assessments For more details please see the study protocol Taut et al submitted
Note The investigators will assess further variables that are not mentioned in the outcome section These are moderator variables that will be only assessed once at baseline and that are described in the study protocol Taut et al in preparation
Note Based on the experiences during the pre-assessments an interim reduction of measures was necessary to prevent overburdening of families more time needed for assessments because of the pandemic situation It was decided to take out some of the other pre-specified outcome measures for the post-assessment for details see outcome section
Note Assessment of parent-child relationship In addition to the coherence rating two scales of the FAARS rating Warmth Criticism were added for the following reasons The FAARS scales are assumed to be closely related to the mechanisms and outcomes of a social learning theory based parenting program and may better capture the expected change These scales also showed good validity in other parenting intervention studies eg Smith et al 2013
Despite the emerging evidence of the effectiveness of parenting interventions in reducing violence against children many local governments and service providers in LMICs face multiple challenges in implementing evidence-based parenting programmes in resource poor contexts Parenting programmes are often too expensive to deliver effectively at scale in low-resource settings due to their complexity intensity and length Parenting programmes developed and evaluated in other contexts also may not fit the local service delivery context and may require adaptation to be relevant to the local culture of families Additional programme content may also be necessary to address acute economic deprivation high community violence and parental distress The process of delivery may also need to be simplified to improve participant engagement and the quality of delivery
As a result it is essential that programmes implemented in LMICs are
Effective at reducing violence against children
Integrated within the existing service delivery system of the country
Feasible and culturally acceptable to service providers and families and
Scalable in terms of their affordability replicability and sustainability while reaching a maximum number of beneficiaries
However there are currently very few parenting programmes that meet these criteria in LMICs such as North Macedonia Republic of Moldova and Romania where the need is the greatest
The Parenting for Lifelong Health PLH initiative is focused on the development evaluation and dissemination of parenting programmes to reduce violence against children and improve child wellbeing in LMIC It was established to address the need to develop low-cost evidence-based parenting programmes that can be integrated within existing service delivery systems in LMIC The PLH for Young Children from 2-9 y PLH-YC programme includes general content like one-on-one timechild-led play praising and rewarding children instructions household rules and routines managing difficult behaviours ignore and consequences reflection and moving on Core activities during sessions include group discussions illustrated vignettes role-plays collaborative problem solving practicing skills at home
The overall RISE project has two general objectives 1 the first objective relates to the adaption optimisation and evaluation of selected best practice intervention condition MOST while 2 the second objective relates to implementation issues RE-AIM
The primary objective of the overall project is adapt optimise and test a parenting programme so that it meets the specific needs and constraints of families in three LMIC in Southeastern Europe The design is informed by the Multiphase Optimisation Strategy MOST and is conduced over 3 distinct phases 1 Preparation 2 Optimisation and 3 Evaluation In Phase 1 the feasibility of the intervention and research methods was tested in a small pilot study in North Macedonia Republic of Moldova and Romania In Phase 2 8 different programme components were tested in a factorial experiment to identify the most effective and cost-effective combination In the present Phase 3 the optimised intervention identified in Phase 2 will be tested in a randomised-controlled trial
A secondary objective of this project is to carefully assess barriers to implementation integration with existing service delivery systems and scale-ups from the outset to facilitate sustainability and real world applicability at the end of the project When introducing such an innovative intervention in resource-limited settings it is important to focus on the implementation processes that increase reach efficacy adoption and sustainability of culturally-adapted and optimized versions of the programme in addition to evaluating programme effectiveness The theoretical model for the implementation framework in the RISE project is RE-AIM Reach Efficacy Adoption Implementation Maintenance Glasgow et al 2011 As a result investigators will examine the adoption defined as the proportion of settings willing to initiate the intervention reach the proportion of eligible individuals that participate in the intervention and implementation the fidelity adherence dosage assessed with multiple measures as well as on effectiveness and sustainability of the RISE project at the organizational and participants level In addition it will be examined how implementation factors influence programme effectiveness and how potential population characteristics might affect outcomes eg moderators such as baseline parent mental health for details see study protocol Taut et al in preparation
The first two Phases have been successfully completed For details of Phase 1 see trial registration httpsclinicaltrialsgovct2showNCT03552250 and study protocol doi 101136bmjopen-2018-026684 For details of Phase 2 please refer to the trial registration httpsclinicaltrialsgovct2showNCT03865485 or the study protocol httpsdoiorg101016jcct2019105855
This presently registered study relates to the Evaluation Phase Phase 3 This randomised-controlled trial ist to test the effectiveness and the cost-effectiveness of the optimised intervention identified in the factorial experiment Phase 2 in the three LMIC North Macedonia Republic of Moldova and Romania More details can be found in the study protocol for Phase 3
Note The investigators have developed a stepwise safety plan in case the local restrictions due to COVID-19 pandemic will not allow in-person assessments and parent groups as planned The safety plan includes the reduction of the number of parents per group size switch to online delivery of PLH-YC and lecture phone assessments For more details please see the study protocol Taut et al submitted
Note The investigators will assess further variables that are not mentioned in the outcome section These are moderator variables that will be only assessed once at baseline and that are described in the study protocol Taut et al in preparation
Note Based on the experiences during the pre-assessments an interim reduction of measures was necessary to prevent overburdening of families more time needed for assessments because of the pandemic situation It was decided to take out some of the other pre-specified outcome measures for the post-assessment for details see outcome section
Note Assessment of parent-child relationship In addition to the coherence rating two scales of the FAARS rating Warmth Criticism were added for the following reasons The FAARS scales are assumed to be closely related to the mechanisms and outcomes of a social learning theory based parenting program and may better capture the expected change These scales also showed good validity in other parenting intervention studies eg Smith et al 2013
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| H2020-SC1-2017-RTD-779318 | OTHER_GRANT | European Commission | None |