Clinical trial NCT04721730: Prevention of Child Mental Health Problems in Southeastern Europe - Phase 3
Official title: Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test, and Extend Parenting for Lifelong Health ' - 'RISE' - The Randomized Controlled Trial (Phase 3 of MOST)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Child Mental Disorder
Keywords: Parenting Programme
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: 2021-01-25
Enrollment: 823
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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").
Primary purpose: PREVENTION

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).

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 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).

Exclusion Criteria (for caregivers/parents):

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

Inclusion Criteria (for facilitators of PLH/lecture):

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.

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" (with 19 items (CBCL ½ - 5) and 18 items (CBCL 6-18), continuous sub-scale score
timeFrame: 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)
measure: Change in prevalence of Externalising Disorders in Children (MINI-KID), binary total score
timeFrame: 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)
measure: Change in Parent Daily Ratings (PDR): oppositional and aggressive sub scale (12 items), continuous sub-scale score
timeFrame: PLH group: after the first, third and fifth session. lecture: after the lecture, 2 and 4 weeks later
Secondary outcomes:
measure: 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
timeFrame: 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)
measure: Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report (shortened version); continuous total score and 2 sub-scale scores
timeFrame: 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)
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: 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)
measure: Change in daily report of effective parenting behaviour (5 items of Alabama Parenting Questionnaire), continuous score
timeFrame: PLH group: after the first, third and fifth session. lecture: after the lecture, 2 and 4 weeks later
measure: Change in parent-child relationship quality as measured via FMSS (Five Minute Speech Sample) coherence; continuous total score
timeFrame: 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)
measure: Change in parent-child relationship quality as measured via FMSS (Five Minute Speech Sample) Family Affective Attitude Rating Scale (FAARS), sub scales Warmth and Criticism; continuous total score
timeFrame: 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)
measure: Change in frequency and incidence of child maltreatment: ISPCAN-Child Abuse Screening Tool-Intervention (ICAST-I)/ self-report (16 items); main focus on continuous total score, 2nd question: any effect of intervention on any of the 3 sub-scale score
timeFrame: 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)
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: 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)
measure: Change in levels of parenting stress: Parenting Stress Scale (18-items); continuous total score
timeFrame: 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)
measure: Change in levels of parental relationship quality: Couple Satisfaction Index / self-report (4 items); continuous total score
timeFrame: 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)
measure: Change in levels of Intimate Partner Violence (29 items); continuous total score and 4 sub-scales (level of severity)
timeFrame: 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)
measure: Change in Child Quality of Life: Child Health Utility 9D (CHU9D; 9 items); continuous total score
timeFrame: 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)
measure: RE-AIM Reach: Enrollment rate
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
measure: RE-AIM Reach: Participation rate
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
Other outcomes:
measure: RE-AIM Implementation: Fidelity Lecture
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
measure: RE-AIM Implementation: Fidelity PLH programme
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
measure: RE-AIM Implementation: Quality of delivery PLH
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
measure: RE-AIM Implementation: Quality of delivery lecture
timeFrame: approx. 4 months after pre-assessment (May/June 2021)
measure: Cost-effectiveness / cost-analyses - CBCL (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)
timeFrame: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Cost-effectiveness / cost-analyses - Parenting Scale (PS)
timeFrame: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Cost-effectiveness / cost-analyses - Parenting of Young Children Scale (PARYC)
timeFrame: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Cost-effectiveness / cost-analyses - Child Quality of life (Child Health Utility 9D, CHU9D; 9 items)
timeFrame: approx. 4 months after pre assessment (May/June 2021); follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Child and Adolescent Behavior Inventory (CABI), oppositional defiant disorder sub scale (9 items); continuous sub-scale score
timeFrame: pre: Jan/Feb 2021
measure: Change in prevalence of ADHD (Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version); binary total score
timeFrame: 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)
measure: Change in Couple Conflict (10 items); continuous total score.
timeFrame: 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)
measure: Change in Coparenting Quality (10 items); continuous total score and 2 subscales.
timeFrame: 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)
measure: Change in Parental Self-Regulation (1 item), continuous core
timeFrame: 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)
measure: Change in Frequency and Quality of Family Dinner (4 items); continuous total score and 2 sub-scales.
timeFrame: pre: Jan/Feb 2021; follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Change in levels of social community support, MOS Social Support Survey - Emotional Support Sub-scale (8 items); continuous sub-scale score
timeFrame: pre: Jan/Feb 2021; follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Change in alcohol misuse: Alcohol Use Disorders Identification Test AUDIT-C, 3 items), continuous total score
timeFrame: pre: Jan/Feb 2021; follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
measure: Change in Participant's General Health (6 items incl. 3 items from the Medical Outcomes Study (MOS) Short Form-12 Health Survey (SF-12)), 3 continuous sub-scale scores
timeFrame: pre: Jan/Feb 2021; follow-up: approx. 10 -12 months after pre-assessment (Dec 2021 - Feb 2022)
Locations:
city: Chisinau
country: Moldova, Republic of
facility: Health for Youth Association
state: MD
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 Bremen
name: Nina Heinrichs, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Klagenfurt
name: Heather Foran, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Oxford
name: Jamie Lachman, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Babes-Bolyai 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 Oxford
name: Frances Gardner, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: Bangor University
name: Judy Hutchings, Prof.
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.
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.
citation: 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.