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

NCT04721730 | Completed DMC

• 2 other identifiers: H2020-779318-3H2020-SC1-2017-RTD-779318
• Study Type: interventional
• Target: 823
• Locations: 3 countries
• Sites: 3

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.

Conditions

Child Mental Disorder

Keywords

Parenting Programme

Outcome Measures

Primary Outcomes (3)

• Change in level of aggressive behaviour in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, sub-scale "Aggressive behaviour" (with 19 items (CBCL ½ - 5) and 18 items (CBCL 6-18), continuous sub-scale score

  The primary outcome child oppositional aggressive behaviour is assessed with 3 indicators: 1) parent-report: The CBCL is part of the Achenbach System of Empirically Based Assessment (ASEBA) and is available for different age ranges, including the targeted range in the present study. For Phase 3, the parent-report versions for children aged 1½-5 and 6-18 are employed. The aggressive behaviour sub scale (CBCL ½ - 5 version: 19 items, CBCL 6-18: 18 items) belongs to the externalising scale and assesses aggressive behaviour (e.g., "Argues a lot"). The total raw score ranges from 0 to 38 in the CBCL ½ - 5 version and 0-36 in the CBCL 6-18 version, with higher scores indicating more aggressive child behaviour. Items are rated on a 3-point Likert scale (2 = very true or often true of the child; 0 = not true of the child).

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

• Change in prevalence of Externalising Disorders in Children (MINI-KID), binary total score

  The primary outcome child oppositional aggressive behaviour is assessed with 3 indicators: 2) clinical interview: The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version (MINI-KID-P) will be used to assess whether the criteria for a) Conduct Disorder (CD) or b) Oppositional Defiant Disorder (ODD) are met (yes/no). The results of the two disorders will be combined to one binary total score with 0 = no externalising disorder and 1 = current externalising disorder (ODD or CD).

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

• Change in Parent Daily Ratings (PDR): oppositional and aggressive sub scale (12 items), continuous sub-scale score

  The primary outcome child oppositional aggressive behaviour is assessed with 3 indicators: 3) daily reports: The PDR oppositional and aggressive sub-scale (10 items) and 2 positive items will be used to monitor child behavioral problems. We excluded the last item from the scale ("he/she pouts") because this question caused translation problems in the three implementation countries during the last assessment. The item was not understood correctly by parents and assessors and thus did not result in valid answers. Parent will report on their child's behaviour within the last 24 hours (answer format: did occur/did not occur). The oppositional and aggressive subscale mean score will be calculating (score range: 0-1) with higher scores indicating more child problem behaviour within the last 24 hours. Additional exploratory analyses will include the mean score of the two positive items (range: 0 -1) with higher values indicating more frequent positive child behaviour.

  PLH group: after the first, third and fifth session. lecture: after the lecture, 2 and 4 weeks later

Secondary Outcomes (14)

• Change in level of internalising problem behaviour in children: Child Behavior Checklist (CBCL) 11/2-5 (31 items) and 6-18 (32 items) parent-report, Internalizing Scale; continuous sub-scale score

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

• Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report (shortened version); continuous total score and 2 sub-scale scores

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

• Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report (21 items); continuous total score

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

• Change in daily report of effective parenting behaviour (5 items of Alabama Parenting Questionnaire), continuous score

  PLH group: after the first, third and fifth session. lecture: after the lecture, 2 and 4 weeks later

• Change in parent-child relationship quality as measured via FMSS (Five Minute Speech Sample) coherence; continuous total score

  pre: Jan/Feb 2021; post: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)

Other Outcomes (17)

• RE-AIM Implementation: Fidelity Lecture

  approx. 4 months after pre-assessment (May/June 2021)

• RE-AIM Implementation: Fidelity PLH programme

  approx. 4 months after pre-assessment (May/June 2021)

• RE-AIM Implementation: Quality of delivery PLH

  approx. 4 months after pre-assessment (May/June 2021)

Study Arms (2)

PLH-YC

EXPERIMENTAL

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.

Behavioral: PLH-YC

Lecture

ACTIVE COMPARATOR

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).

Behavioral: Lecture

Interventions

PLH-YC 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.

Also known as: Parenting for Lifelong Health for Young Children

PLH-YC

Lecture 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.

Also known as: Raising Healthy Children

Lecture

Eligibility Criteria

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

You may qualify if:

• 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 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
• 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 of being randomized to one of the two conditions
• Provision of Informed consent to participate in the full study
• Language skills to participate in the group/lecture (e.g., with someone that helps with the translation).

You may not qualify if:

• Age 18 or older;
• Participate in PLH facilitator training workshop /lecture training workshop;
• Agreement to either deliver the lecture (one session) or PLH-YC (five sessions);
• Provision of consent to participate in the full study.

Sponsors & Collaborators

• University of Bremen: 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, MD, 2020, 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 (4)

• 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 BACKGROUND

• 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.

  PMID: 31669446 BACKGROUND

• 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.

  PMID: 34961518 BACKGROUND

• 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

Related Links

• Trial Registration Phase 1
• Trial Registration Phase 2

MeSH Terms

Conditions

Neurodevelopmental Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Nina Heinrichs, Prof.

  University of Bremen

  PRINCIPAL INVESTIGATOR

• Heather Foran, Prof.

  University of Klagenfurt

  PRINCIPAL INVESTIGATOR

• Jamie Lachman, Dr.

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Adriana Baban, Prof.

  Babes-Bolyai 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

• Frances Gardner, Prof.

  University of Oxford

  PRINCIPAL INVESTIGATOR

• Judy Hutchings, Prof.

  Bangor University

  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: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be allocated to groups after completion of pre-assessment. Thus, outcome assessors and participants will be blind to group allocation at pre-assessment. The implementation of the intervention will be conducted by different research staff (program coordinators and facilitators) than the assessments. Thus, data assessors are not aware of the group allocation of participants at the later assessment points (post, follow-up). To make sure that participants do not reveal their group allocation during the post- and follow-up assessment to the assessor, the data assessor will ask the participants to not share the group allocation at the beginning of the interview. Unblinding will only happen in case the participant reports a (serious) adverse event during the interview (at post- or follow-up assessment). Also, the data analysis team (Klagenfurt) will remain blind to group allocation, because the unrevealing of assignment will be done in Bremen.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomly allocated 1:1 to the intervention group (5 sessions parent training "Parenting for Lifelong Health for Young Children"), and the control group (one lecture on parenting "Raising Healthy Children").

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 25, 2021
• Study Start: December 7, 2020
• Primary Completion: March 14, 2022
• Study Completion: March 14, 2022
• Last Updated: March 22, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: at the end of the project

Locations

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