Clinical trial NCT03552250: Prevention of Child Mental Health Problems in Southeastern Europe
Official title: Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mental Disorder
Keywords: Parenting Program
Lead sponsor: Technische Universitaet Braunschweig
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: 2018-06-11
Enrollment: 140
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The aim of this study is to develop an adapted version of a low-cost parenting program (Parenting for Lifelong Health for Young Children, PLH) to the specific needs of families in three low- and middle income countries (LMICs) in southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova). The investigators want systematically evaluate key barriers and facilitators at the local, national and international levels that impact prevention of child behavioral disorders.

The investigators will prepare training materials adapted to Romanian, Moldovian, Albanian, Macedonian, and Russian and train facilitators and mentor coaches in the delivery of the PLH program in each country. Also, a pre-post study will be conducted testing the feasibility of the program and the evaluation and implementation methods with 40 families at each country site. This includes examination of outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors.

This feasibility study is part of a larger implementation project. Developed on the MOST framework (the multiphase optimization strategy), this specific study will reflect the implementation of the first phase. There are two more phases to come: the Parenting for Lifelong Health for Young Children program will be optimized within the three countries by determining which components are most efficacious and cost-effective (phase 2). The optimized PLH programs will be tested in three RCTS in the countries (phase 3).

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) (Mikton et al., 2014). In particular, 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 (Barlow et al., 2006; Knerr et al., 2013, Chen \& Chan, 2015). 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 implementing evidence-based parenting programs in resource poor contexts (Mikton, 2012). Parenting programs are often too expensive to deliver effectively at scale in low-resource settings due to their complexity, intensity, and length (Knerr et al., 2013). 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,
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 present study utilizes the Multiphase Optimization Strategy (MOST) as a framework for increasing the reach and enhancing the implementation of a parenting intervention for families with 2-9 years old children (Parenting for Lifelong Health for Young Children, PLH 2-9) in three southeastern European countries with restricted resources. The MOST framework is implemented over 3 distinct phases: 1) Preparation and Adaptation, 2) Optimization, and 3) Evaluation.

The Preparation and Adaptation Phase lays the foundation for program optimisation. This may include formative research, cultural/contextual adaptation, and feasibility piloting in preparation for further testing. A key objective of the Preparation Phase is to confirm the conceptual model of RISE that informs the selection of program components to optimize. Feasibility studies are considered important steps in preparation for larger experimental studies. They allow for the assessment of intervention feasibility by examining program dosage, implementation fidelity, and participant satisfaction. Although often limited in their ability to detect significant effects due to small sample sizes, feasibility studies are also opportunities to conduct exploratory analyses of intervention effects. This is particularly important when probing for potential harmful effects prior to testing in a larger population.

The RISE Study therefore includes developing three locally adapted variants of a promising parenting program which will be focused on the needs of families from LMICs with children ages 2 to 9 years who show elevated levels of externalizing problem behavior.

This feasibility study can be located in the Preparation and Adaptation phase of MOST. It is a small-scale feasibility pilot to test the feasibility of the 12-session PLH 2-9 and the evaluation and implementation methods (including preliminary outcomes of program effects). It is planned to create a locally-developed, evidence-based parenting intervention for 40 families per country. The following activities are linked to this study:

* Interviews with officials, experts and practitioners: interviews with 12-20 officials, experts and practitioners in order to gather information relating to their perceptions of the design and adaptation of a parenting intervention in;
* Gathering input from Parenting Experts Working Group in each country: meetings with a 6-member Parenting Experts Working Group, in order to incorporate these findings and their own expert opinions into the adaptation of PLH 2-9 content, process, and structure;
* Pre-Post Feasibility Study: a small-scale, pre-post evaluation to test the feasibility of the program with 40 families with children aged 2-9 years with elevated levels of child behavior problems (assessed with the Eyberg Child Behaviour Inventory, ECBI, a parent report of child externalizing problem behaviors) in each country site to examine outcomes related to implementation fidelity, program acceptability, and preliminary program effectiveness on reducing child behavior problems and associated risk factors. Moreover, the feasibility of the assessment procedures and the measures (not yet available in these regions/languages) will be tested. This means that based on the psychometric results of the feasibility study, measures may or may not be suitable for evaluation all of the listed outcomes.
* Preparation of the training materials adapted in Romanian, Moldovian, Albanian, Macedonian, and Russian, taking into account adaptation needs identified in the first three activities;
* Training of facilitators and mentor coaches in the delivery of the PLH 2-9 program in each country.

Based on the feasibility study (Adaptation and Preparation phase), the other two phases of the MOST framework will be tested in future research (studies will be registered separately):

* Phase 2: Optimization study using a factorial design testing 4 components of the parenting intervention
* Phase 3: The evaluation phase will involve testing of the optimized design (identified in phase 2) in a multisite 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 program in addition to evaluating program 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 program effectiveness, and how potential population characteristics might affect outcomes (e.g., moderators such as child age, gender, ethnicity, poverty, level of child behaviour problems, and other adversities).

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 he/she chooses to be part of the study (based on the Eyberg Child Behavior Inventory);
  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 to participate in the PLH 2-9 program;
  6. Provision of Informed consent to participate in the full stud

Exclusion Criteria:

* for caregivers/parents: 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.

Primary outcomes:
measure: Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in Prevalence of Oppositional Defiant Disorder (ODD) and Conduct Disorder (CD)) in children: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; MINI-KID-P Clinician-rated
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
Secondary outcomes:
measure: Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in Prevalence of Anxiety Disorders in children: Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID-P) / Structured Clinical Diagnostic Interview for Parents, Clinician-rated
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of parental well-being: WHO-5 Well-Being Scale/ self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of parental stress: Parenting Stress Index - Short Form (PSI-SF) / self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in incidence and frequency of child maltreatment: ISPCAN-Child Abuse Screening Tool -Intervention / self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
Other outcomes:
measure: Change in levels of Intimate Partner Violence: Adapted Revised Conflict Tactics Scale-Short Form
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of family functioning, Family assessment device Short form
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of parental relationship quality: Kansas Marital Satisfaction Scale
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: Change in levels of social community support, MOS Social Support Survey - Emotional Support Subscale, self-report
timeFrame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)
measure: RE-AIM Reach: Recruitment rate
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Reach: Enrollment rate
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Reach: Participation rate
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Implementation Dosage in hours
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Implementation Dosage (points of contact)
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Implementation Fidelity (percentage of session activities delivered per session)
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Implementation Fidelity (mean percent of activities delivered per session)
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: RE-AIM Implementation Quality
timeFrame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment)
measure: Participants observed change in parenting practices and child behaviour at home during program
timeFrame: Post (approximately 16 - 24 weeks after pre-assessment)
measure: Acceptability and appropriateness of program materials, delivery, and key program components
timeFrame: Post (approximately 16 - 24 weeks after pre-assessment)
measure: Existing barriers to participation during sessions and engagement in home practice and other activities
timeFrame: Post (approximately 16 - 24 weeks after pre-assessment)
measure: Challenges in implementing the program
timeFrame: Post (approximately 16 - 24 weeks after pre-assessment)
Locations:
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
city: Chisinau
country: Moldova, Republic of
facility: Health For Youth Association
city: Cluj-Napoca
country: Romania
facility: Babes Boylai University
Study officials:
affiliation: Adria-Adria-University 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: 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.