Prevention of Child Mental Health Problems in Southeastern Europe

NCT03552250 | Completed DMC

• 2 other identifiers: H2020-779318H2020-SC1-2017-RTD-779318
• Study Type: interventional
• Target: 140
• Locations: 3 countries
• Sites: 3

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).

Conditions

Child Mental Disorder

Keywords

Parenting Program

Outcome Measures

Primary Outcomes (2)

• Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale

  The primary outcome child behavior problems is assessd with two methods: 1) parent-report: Child Behavior Checklist (CBCL). The CBCL is part of the Achenbach System of Empirically Based Assessment (ASEBA) and is available for different age ranges. For the present study, the parent-report versions for children aged 1½ - 5 and 6-18 are employed. It is the most widely used instrument for assessing child behavioral and emotional symptoms. The externalizing subscale raw score ranges from 0 to 70 (CBCL 6-18 version) and 0 to 48 (CBCL ½ - 5 version) and can be converted into standardized scores (e.g., T scores, with Mean = 50, SD = 10) with higher scores indicating more problems.

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• 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

  The primary outcome child behavior problems is assessed with two methods: 2) structured interview, clinician-rated: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; (MINI-KID-P) evaluates the presence of current psychiatric disorders (based on ICD-10 and DSM-5). It will be assessed whether or not the criteria for a) conduct disorder (F91.1, F91.2, F91.9) or b) Oppositional Defiant disorder (F91.3) are met (yes/no). The results of the two disorders will be combined to one binary total score with 0 (no externalizing disorder) and 1 (current externalizing disorder (ODD or CD)). As the sample size is small in this study phase, there is no real change in prevalence expected. However, the feasibility of the interview will be tested for later study phases with larger sample sizes.

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

Secondary Outcomes (8)

• Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• 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

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• Change in levels of parental well-being: WHO-5 Well-Being Scale/ self-report

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• Change in levels of parental stress: Parenting Stress Index - Short Form (PSI-SF) / self-report

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

Other Outcomes (16)

• Change in levels of Intimate Partner Violence: Adapted Revised Conflict Tactics Scale-Short Form

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• Change in levels of family functioning, Family assessment device Short form

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

• Change in levels of parental relationship quality: Kansas Marital Satisfaction Scale

  Pre-Post (approximately 16 - 20 weeks after pre-assessment)

Study Arms (1)

Parenting for Lifelong Health

OTHER

Parenting Programme "Parenting for Lifelong Health for Young Children" (PLH) for parents of children aged 2-9, 12 sessions

Behavioral: Parenting for Lifelong Health for Young Children

Interventions

Parenting for Lifelong Health for Young Children BEHAVIORAL

In this study, the 12 sessions-PLH version for parents of young children (2-9 years) will be delivered. The PLH (2 - 9) programme is delivered in groups of parents and includes the following general content 1) One-on-one time, 2) Say what you see, 3) Talking about feelings, 4) Praising and rewarding our children, 5) Giving positive, specific, and realistic instructions, 6) Establishing household rules and routines, 7) Redirecting negative behavior, 8) Ignoring negative attention seeking and demanding behavior, 9) Using consequences to support compliance, 10) Using Cool-down as a consequence for aggressive behavior, 11) Avoiding and resolving conflicts, 12) Reflection celebration, and moving on.

Also known as: PLH Programme

Parenting for Lifelong Health

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• for caregivers/parents:
• age 18 or older;
• primary caregiver responsible for the care of a child between the ages of two and nine;
• 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);
• 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;
• agreement to participate in the PLH 2-9 program;
• Provision of Informed consent to participate in the full stud

You may not qualify if:

• 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.

Sponsors & Collaborators

• Technische Universitaet Braunschweig: lead
• University of Klagenfurt: collaborator
• University of Oxford: collaborator
• Bangor University: collaborator
• Babes-Bolyai University: collaborator
• Institute for Marriage, Family and Systemic Practice - ALTERNATIVA: collaborator
• Health for Youth Association, Moldova: collaborator
• University of Cape Town: collaborator
• Georgia State University: collaborator

Study Sites (3)

Health For Youth Association

Chisinau, MD2020, Moldova

Location

Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

Skopje, 1000, North Macedonia

Location

Babes Boylai University

Cluj-Napoca, 400084, Romania

Location

Related Publications (2)

• 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.

  PMID: 39154169 DERIVED

• 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.

  PMID: 30782760 DERIVED

Related Links

• Project website

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Heather Foran, Prof.

  Adria-Adria-University Klagenfurt

  PRINCIPAL INVESTIGATOR

• Jamie Lachman, Dr.

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Frances Gardner, Prof.

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Judy Hutchings, Prof.

  Bangor University

  PRINCIPAL INVESTIGATOR

• Adriana Baban, Prof.

  Babes Boylai University

  PRINCIPAL INVESTIGATOR

• Marija Raleva, Prof.

  Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

  PRINCIPAL INVESTIGATOR

• Galina Lesco, Dr.

  Health for Youth Association, Moldova

  PRINCIPAL INVESTIGATOR

• Catherine Ward, Prof.

  University of Cape Town

  PRINCIPAL INVESTIGATOR

• Xiangming Fang, Prof.

  Georgia State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Nina Heinrichs

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: June 11, 2018
• Study Start: April 26, 2018
• Primary Completion: November 19, 2018
• Study Completion: December 2, 2018
• Last Updated: December 4, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will share

Locations

NO (1); MO (1); RO (1)