Clinical trial NCT03865485: Prevention of Child Mental Health Problems in Southeastern Europe (RISE) - A Factorial Study (Phase 2 of MOST)
Official title: RISE- Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health - A Factorial Study (Phase 2 of MOST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mental Disorder
Keywords: Parenting Program
Lead sponsor: University of Bremen
Sponsor class: OTHER
Collaborators: name: University of Klagenfurt
name: University of Oxford
name: Bangor University
name: Babes-Bolyai University
name: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Health for Youth Association, Moldova
name: University of Cape Town
name: Georgia State University
First posted: 2019-03-07
Enrollment: 835
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: Factorial Assignment For the study, a factorial design will be used testing 3 components. With these three components, there will be a total of eight conditions. The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components, not to compare the 8 experimental conditions to each other. Each main effect and interaction estimate is based on all of the experimental conditions.
Primary purpose: PREVENTION

Brief summary: The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu).

The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components.

At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.

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 programs 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 programs typically aim to strengthen caregiver-child relationships through positive parenting and help parents to manage child behavior 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 programs in resource poor contexts. Parenting programs are often too expensive to deliver effectively at scale in low-resource settings due to their complexity, intensity, and length. Parenting programs 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 program 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 programs implemented in LMICs are

1. Effective at reducing violence against children,
2. Integrated within the existing service delivery system of the country,
3. Feasible and culturally acceptable to service providers and families, and
4. Scalable in terms of their affordability, replicability, and sustainability while reaching a maximum number of beneficiaries.

However, there are currently very few parenting programs that meet these criteria in LMICs (such as Romania, FYR of Macedonia and Republic of Moldova), where the need is the greatest.

The Parenting for Lifelong Health (PLH) initiative is focused on the development, evaluation, and dissemination of parenting programs 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 programs that can be integrated within existing service delivery systems in LMIC. The PLH for Young Children from 2-9 y. (PLH 2-9) program 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 present study utilizes the Multiphase Optimization Strategy (MOST) and RE-AIM framework for increasing the reach and enhancing the implementation of PLH 2-9 in three Southeastern European countries with restricted resources. The MOST framework is implemented over 3 distinct phases: 1) Preparation, 2) Optimization, and 3) Evaluation.

The overall RISE project has two general objectives: (1) the first objective relates to the adaption, optimizing and evaluation of selected best practice intervention condition (MOST), while (2) the second objective relates to implementation issues (RE-AIM).

This presently registered study relates to the Optimization Phase (phase 2). This cluster factorial experiment is to inform the selection of the most effective and cost-effective components to include in a prevention package prior to testing in the subsequent RCT.

The factorial experiment will be conducted across the three countries in Southeastern European country sites (N = 48 clusters, 288 families per country site). The study will focus on the recruitment of families from LMICs with children aged two to nine years who have elevated child behaviour problems as well as high-risk groups, i.e. such as Roma families. Program facilitators (N = 80; 16 in FYR of Macedonia, 32 in Republic of Moldova, and in 32 Romania) will be recruited from local agencies and schools. Program coaches (N = 11; 3 in FYR of Macedonia, 4 in Republic of Moldova, and in 4 Romania) will be selected from personnel who previously implemented the PLH 2-9 program during Phase 1.

The following intervention components have been selected (the three components are related to program implementation and efficacy):

Component 1: Engagement booster (high/low): Half of the participants will receive a communication booster (including weekly text messages reminders and 5-minute phone consultations twice a month from facilitators) and an enhanced incentives package (including lunch @ approx. 2-4 euros/person, transport to group sessions when necessary (FYR of Macedonia, and Republic of Moldova only), raffle prize @ approx. 5 euros/person, food parcels @ approx. 2-5 euros/person, and reward for attending all or all but one sessions @ approx. 3-5 euros/person) and half will not receive any engagement boosters. All participants, regardless of condition, will receive a basic incentive package (including child care and a snack) at each group session.

Component 2: Program Length (long: 10 sessions; short: 5 sessions): Half of the participants will receive 5 group sessions (i.e., 10 hours of program delivery and half of the participants will receive 10 group sessions (i.e., 20 hours of program delivery). Both short and long versions will contain the same content as each other and be delivered over the same time period (weekly for the 10 session and fortnightly for the 5 session).

Component 3: Fidelity booster (high supervision/low supervision): Half of the facilitators will receive facilitator training workshop (3-5 days) plus a structured weekly supervision session by a local coach including video feedback (high supervision), while half of the facilitators receive the facilitator training workshop and supervision only upon request (low supervision; low component level).

With this number of components, the current factorial experimental trial will randomize 16 geographical areas to 8 experimental conditions (cluster randomization) in each country. There will be a total of 16 groups (with 2 groups per experimental condition).

It is important to note that although there are 8 experimental conditions, this experiment should not be considered an 8-arm RCT. The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components, not to compare the 8 experimental conditions to each other. Each main effect and interaction estimate is based on all of the experimental conditions. Instead of recruiting the originally planned 240 participants per country, we will over-recruit (n = 288 per country) to account for study attrition identified in Phase 1 (https://clinicaltrials.gov/ct2/show/NCT03552250?term=Prevention+of+Child+Mental+Health+Problems+in+Southeastern+Europe+%28RISE%29\&rank=1) (approx. 20-30%) in order to avoid empty cells and being at risk of being underpowered.

This study will examine the following hypotheses related to the selected components based on a conceptual model\* tested in the factorial experiment:

1. Component 1: Engagement Booster. We hypothesize that providing enhanced engagement boosters (i.e., high participation incentives and communication boosters) compared to a low level of engagement boosters (i.e., low participation incentives and no communication boosters) will result in higher retention and participation of parents, which in turn will indirectly result in improvements in parenting outcomes, child behavior and other secondary outcomes (via indirect effects).
2. Component 2: Program Length. We hypothesize that those receiving the shorter length program will have higher retention and participation rates than those receiving the longer program. However, the 10-session program condition compared to the 5-session program condition will have higher dosage and therefore, we expect no difference on outcomes.
3. Component 3: Fidelity Booster. We hypothesize that higher levels of fidelity boosters (i.e., training plus structured video feedback supervision) will result in higher program fidelity which will yield larger intervention effects on primary and secondary outcomes than low levels of fidelity booster (i.e., training plus supervision on-demand).
4. We hypothesize that there will be an interaction effect between Engagement Boosters and Program Length: Program Length will interact with engagement booster and lead to greater change in primary and secondary outcomes when both components are on high level. In addition, we expect a main effect of Engagement Booster of retention and participation rates, such that regardless of Program Length, high levels of Engagement Boosters will be related to higher retention and participation rates.
5. We hypothesize that there will be an interaction effect between Fidelity Booster and Engagement Booster components, such that higher levels of Fidelity Booster and Engagement Booster will result in higher retention and participation rates than either condition alone. Higher retention and participation rates will in turn be associated with greater change in primary and other secondary outcomes.
6. There will be an interaction effect between Program Length and Fidelity Booster in which program length (i.e., 10 sessions instead of 5 sessions) in combination with higher levels of Fidelity Booster (i.e., instead of on-demand) will result in larger effect on primary and secondary outcomes than either component alone.
7. Moderators: Higher baseline levels of parental mental health symptoms and problems in the family environment will be associated with greater change on primary and secondary outcomes. Other moderators of intervention effects, such as parental age, ethnicity, and gender of the child, will be examined on an exploratory basis.
8. Economic Analyses: The objective of the economic analysis for phase 2 of this project is to explore and compare the cost-effectiveness ratios for different combinations of program components and determine the most cost-effective combinations. Cost-effectiveness ratios in terms of Euros per 1-point reduction of the CBCL subscale "Aggressive Behavior" of the PLH 2-9 program and Euros per quality-adjusted life-year (QALY) gained will be calculated to assess and compare the cost-effectiveness of different combinations of program components.

In preparation for the factorial experiment in phase 2 of this study, a 5-session version of PLH 2-9 will be developed from the original program as a potentially more affordable and more accessible program. The PLH 2-9 will include the following session contents (independent of program length): one-on-one time/child-led play; praising and rewarding children; instructions, household rules, and routines; managing difficult behaviors: ignore and consequences; reflection and moving on.

\* The conceptual model will be published in a manuscript version of the study protocol (preferably open access; anticipated submission date: April 2019).

Eligibility criteria: Inclusion Criteria (for caregivers/parents):

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 above the mean based on normative data
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 the different conditions in the study (PLH for Children program);
6. Provision of Informed consent to participate in the full study.

Exclusion Criteria (for caregivers/parents):

Exclusion criteria for adult parents or caregivers comprise:

* any adult 1) exhibiting severe mental health problems or acute mental disabilities;
* 2) that has been referred to child protection services due to child abuse.

Inclusion Criteria (for program facilitators):

1. Age 18 or older;
2. Participate in PLH facilitator training workshop;
3. Available to deliver the entire PLH 2-9 intervention
4. Provision of Informed Consent to participate in the full study

Inclusion Criteria (for program coaches)

1. Age 18 or older;
2. Previous participation in PLH facilitator training workshop;
3. Participate in PLH coach training workshop;
4. Available to deliver coaching sessions during delivery of the PLH 2-9 intervention
5. Provision of Informed Consent to participate in the full study

Primary outcomes:
measure: Change in level of aggressive behaviour in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, sub-scale "Aggressive behaviour" (from the Externalizing Scale)
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report (shortened version); total score
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report (21 items); continuous total score
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Secondary outcomes:
measure: Change in level of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 (31 items) and 6-18 (32 items) parent-report, Internalizing Scale; continuous sub-scale score
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report (21 items); continuous total score
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Change in frequency and incidence of child maltreatment: ISPCAN-Child Abuse Screening Tool-Intervention / self-report (16 items); main focus on continuous total score, 2nd question: any effect of intervention on any of the 3 sub-scale scores?
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: RE-AIM Implementation: Quality
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
measure: RE-AIM Reach: Enrolment rate
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
measure: RE-AIM Reach: Participation rate
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
Other outcomes:
measure: Change in levels of Intimate Partner Violence (29 items); continuous total score and 4 sub-scales (level of severity)
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Change in levels of parental relationship quality: Couple Satisfaction Index / self-report (4 items); continuous total score
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Child and Adolescent Behavior Inventory (CABI), oppositional defiant disorder subscale (9 items)
timeFrame: Pre (before start of intervention)
measure: Change in quality of life: Child Health Utility 9D (CHU9D; 9 items)
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: Cost-effectiveness / cost-analyses
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
measure: RE-AIM Reach: Recruitment rate
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
measure: RE-AIM Implementation: Fidelity (percentage of session activities delivered per session)
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
measure: RE-AIM Implementation: Fidelity (mean percent of activities delivered per session)
timeFrame: post: approx. 7 months after pre assessment (September/October 2019)
measure: Change in levels of parental stress: Parental Stress Scale (18-items)
timeFrame: pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Health for Youth Association
city: Skopje
country: North Macedonia
facility: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
city: Cluj-Napoca
country: Romania
facility: Babes Boylai University
Study officials:
affiliation: University of Klagenfurt
name: Heather Foran, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Jamie Lachman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Frances Gardner, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangor University
name: Judy Hutchings, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Babes Boylai University
name: Adriana Baban, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
name: Marija Raleva, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Health for Youth Association, Moldova
name: Galina Lesco, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cape Town
name: Catherine Ward, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Georgia State University
name: Xiangming Fang, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barlow J, Johnston I, Kendrick D, Polnay L, Stewart-Brown S. Individual and group-based parenting programmes for the treatment of physical child abuse and neglect. Cochrane Database Syst Rev. 2006 Jul 19;(3):CD005463. doi: 10.1002/14651858.CD005463.pub2.
citation: Chen M, Chan KL. Effects of Parenting Programs on Child Maltreatment Prevention: A Meta-Analysis. Trauma Violence Abuse. 2016 Jan;17(1):88-104. doi: 10.1177/1524838014566718. Epub 2015 Jan 8.
citation: Knerr W, Gardner F, Cluver L. Improving positive parenting skills and reducing harsh and abusive parenting in low- and middle-income countries: a systematic review. Prev Sci. 2013 Aug;14(4):352-63. doi: 10.1007/s11121-012-0314-1.
citation: Mikton, C. (2012). Two challenges to importing evidence-based child maltreatment prevention programs developed in high-income countries to low- and middle-income countries: Generalizability and affordability. In H. Dubowitz (Ed.), World perspectives on child abuse (p. 97). Aurora, CO: International Society for the Prevention of Child Abuse and Neglect.
citation: 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.