Prevention of Child Mental Health Problems in Southeastern Europe - Phase 3

NCT ID: NCT04721730

Last Updated: 2022-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 823 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-07
• Study Completion Date: 2022-03-14

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.

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 time/child-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 (e.g., 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 (https://clinicaltrials.gov/ct2/show/NCT03552250) and study protocol (doi: 10.1136/bmjopen-2018-026684). For details of Phase 2, please refer to the trial registration (https://clinicaltrials.gov/ct2/show/NCT03865485) or the study protocol (https://doi.org/10.1016/j.cct.2019.105855).

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 (e.g., Smith et al., 2013).

Conditions

Child Mental Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

PLH-YC

The Parents will receive the optimised version of the Parenting for Lifelong Health for Young Children from 2-9 y. (PLH-YC) identified in Phase 2.

The groups will be conducted with 12 parents per group (with 2 facilitators). If local restrictions due to COVID-19 restrictions do not allow-in person meetings of this size, we will reduce the sample size (6 parents per group, and facilitator) and or conduct the groups online (e.g., using an online video software).

For each session, parents will receive a snack (or food voucher of same amount), childcare, transportation support (if needed), and a certificate at the end. Also, parents participating in at least four out of five PLH sessions will get a small gift. If the groups need be conducted online because of the COVID-19 pandemic, the parents will receive pre-paid data or another voucher of the same amount.

Group Type: EXPERIMENTAL

PLH-YC

Intervention Type: BEHAVIORAL

There will be 5 weekly 2-hour sessions. The optimised PLH-YC uses a participatory, non-didactic approach to engage parents. Parents learn positive parenting skills and how to manage child behaviour problems. The program includes Session 1: One-on-One Time and Say What You See, Session 2: Praise and Rewards, Session 3: Instructions, Redirect, Rules, and Routines, Session 4: Ignore and Consequences, Session 5: Reflection and Moving On. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.

Lecture

Parents will receive a lecture called "Raising Healthy Children".

The lecture will be conducted with 12 parents per group (with one facilitator). If local restrictions due to COVID-19 pandemic will not allow in-person meetings, the groups will be online (e.g., using a video meeting software).

During the lecture, parents will receive a snack (or a food voucher of the same amount), childcare, transportation support (if needed), and a certificate at the end. If the lecture needs be conducted online because of the COVID-19 pandemic and associated restrictions, the parents will receive pre-paid data or another voucher of the same amount (instead of childcare, transport voucher and the snack).

Group Type: ACTIVE_COMPARATOR

Lecture

Intervention Type: BEHAVIORAL

Lecture on parenting. This is a 26-slides power-point presentation that was developed by the University of Bremen for the purpose of this study. Duration: 1 to 1.5 hours. Content: 1) Stages of child development; (2) Potential risk factors for child emotional or behaviour problems; (3) Resources and protective factors; (4) Tips: What parents can do to promote children's development.

Interventions

PLH-YC

There will be 5 weekly 2-hour sessions. The optimised PLH-YC uses a participatory, non-didactic approach to engage parents. Parents learn positive parenting skills and how to manage child behaviour problems. The program includes Session 1: One-on-One Time and Say What You See, Session 2: Praise and Rewards, Session 3: Instructions, Redirect, Rules, and Routines, Session 4: Ignore and Consequences, Session 5: Reflection and Moving On. Core activities during sessions include group discussions illustrated vignettes, role-plays, collaborative problem solving, practicing skills at home.

Intervention Type: BEHAVIORAL

Lecture

Lecture on parenting. This is a 26-slides power-point presentation that was developed by the University of Bremen for the purpose of this study. Duration: 1 to 1.5 hours. Content: 1) Stages of child development; (2) Potential risk factors for child emotional or behaviour problems; (3) Resources and protective factors; (4) Tips: What parents can do to promote children's development.

Intervention Type: BEHAVIORAL

Other Intervention Names

Parenting for Lifelong Health for Young Children; Raising Healthy Children

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older;

2. Primary caregiver responsible for the care of a child between the ages of two and nine;

3. Report elevated levels of child behavior problems for the child that he/she chooses to be part of the study (based on the Child and Adolescent Disruptive Behavior Inventory, oppositional defiant disorder subscale (8 items); scores of 10 or more

4. Have lived in the same household as this child at least four nights a week in the previous month and will continue to do so;

5. Agreement of being randomized to one of the two conditions

6. Provision of Informed consent to participate in the full study

7. Language skills to participate in the group/lecture (e.g., with someone that helps with the translation).

1. Age 18 or older;

2. Participate in PLH facilitator training workshop /lecture training workshop;

3. Agreement to either deliver the lecture (one session) or PLH-YC (five sessions);

4. Provision of consent to participate in the full study.

Exclusion Criteria

1. Parents with legal restriction to child care - indirectly assessed via the inclusion criterion on the number of nights/day with the child/per week

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Klagenfurt

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: collaborator

Bangor University

OTHER

Sponsor Role: collaborator

Babes-Bolyai University

OTHER

Sponsor Role: collaborator

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

OTHER

Sponsor Role: collaborator

Health for Youth Association, Moldova

OTHER

Sponsor Role: collaborator

University of Cape Town

OTHER

Sponsor Role: collaborator

Georgia State University

OTHER

Sponsor Role: collaborator

University of Bremen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nina Heinrichs, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Bremen

Heather Foran, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Klagenfurt

Jamie Lachman, Dr.

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Adriana Baban, Prof.

Role: PRINCIPAL_INVESTIGATOR

Babes-Bolyai University

Marija Raleva, Prof.

Role: PRINCIPAL_INVESTIGATOR

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Galina Lesco, Dr.

Role: PRINCIPAL_INVESTIGATOR

Health for Youth Association, Moldova

Frances Gardner, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Oxford

Judy Hutchings, Prof.

Role: PRINCIPAL_INVESTIGATOR

Bangor University

Catherine Ward, Prof.

Role: PRINCIPAL_INVESTIGATOR

University of Cape Town

Xiangming Fang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Georgia State University

Locations

Health for Youth Association

Chisinau, MD, Moldova

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, , North Macedonia

Babes Boylai University

Cluj-Napoca, , Romania

Countries

Moldova; North Macedonia; Romania

References

Frantz I, Foran HM, Lachman JM, Jansen E, Hutchings J, Baban A, Fang X, Gardner F, Lesco G, Raleva M, Ward CL, Williams ME, Heinrichs N. Prevention of child mental health problems in Southeastern Europe: a multicentre sequential study to adapt, optimise and test the parenting programme 'Parenting for Lifelong Health for Young Children', protocol for stage 1, the feasibility study. BMJ Open. 2019 Jan 25;9(1):e026684. doi: 10.1136/bmjopen-2018-026684.

Reference Type: BACKGROUND

PMID: 30782760 (View on PubMed)

Lachman JM, Heinrichs N, Jansen E, Bruhl A, Taut D, Fang X, Gardner F, Hutchings J, Ward CL, Williams ME, Raleva M, Baban A, Lesco G, Foran HM. Preventing child mental health problems through parenting interventions in Southeastern Europe (RISE): Protocol for a multi-country cluster randomized factorial study. Contemp Clin Trials. 2019 Nov;86:105855. doi: 10.1016/j.cct.2019.105855. Epub 2019 Oct 24.

Reference Type: BACKGROUND

PMID: 31669446 (View on PubMed)

Taut D, Baban A, Frantz I, Danila I, Lachman JM, Heinrichs N, Ward CL, Gardner F, Fang X, Hutchings J, Raleva M, Lesco G, Murphy H, Foran H. Prevention of child mental health problems through parenting interventions in Southeastern Europe (RISE): study protocol for a multi-site randomised controlled trial. Trials. 2021 Dec 27;22(1):960. doi: 10.1186/s13063-021-05817-1.

Reference Type: BACKGROUND

PMID: 34961518 (View on PubMed)

Frantz I, Foran HM, Lachman JM, Gardner F, McMahon RJ, Ogden T, Hutchings J, Costin MR, Kunovski I, Raleva M, Mueller J, Heinrichs N. Adverse event assessment in a parenting programme: experiences from a multisite randomised controlled trial. Trials. 2024 Aug 17;25(1):547. doi: 10.1186/s13063-024-08357-6.

Reference Type: DERIVED

PMID: 39154169 (View on PubMed)

Related Links

https://clinicaltrials.gov/ct2/show/NCT03552250

Trial Registration Phase 1

https://clinicaltrials.gov/ct2/show/NCT03865485

Trial Registration Phase 2

Other Identifiers

H2020-SC1-2017-RTD-779318

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H2020-779318-3

Identifier Type: -

Identifier Source: org_study_id