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Child Mental DisorderRISENCT03552250

Prevention of Child Mental Health Problems in Southeastern Europe

A study testing Parenting for Lifelong Health for Young Children in people with Child Mental Disorder, run by Technische Universitaet Braunschweig at 3 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Child Mental Disorder
What is being tested?
Parenting for Lifelong Health for Young Children
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
3 sitesin 3 countries
Study dates
26 Apr 2018to 2 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 3 countries.

3 sites in 3 countries

Moldova1 site
  • Health For Youth Association

    Chisinau, MD2020

Other trials in Moldova

North Macedonia1 site
  • Institute for Marriage, Family and Systemic Practice - ALTERNATIVA

    Skopje, 1000

Other trials in North Macedonia

Romania1 site
  • Babes Boylai University

    Cluj-Napoca, 400084

Other trials in Romania

About this study

Official title: Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health

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).

Read the 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).

Being tested
Parenting for Lifelong Health for Young Children
Keywords
Parenting Program
Medical subject headings
Neurodevelopmental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Parenting for Lifelong Health for Young ChildrenBehavioural

    Also called PLH Programme

    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.

Study groups in NCT03552250
Study groupRoleWhat they receive
Parenting for Lifelong HealthOtherParenting Programme "Parenting for Lifelong Health for Young Children" (PLH) for parents of children aged 2-9, 12 sessions
Receives: Behavioral: Parenting for Lifelong Health for Young Children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.

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

Secondary outcomes (8)
  1. Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale

    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 internalizing subscale raw score ranges from 0 to 64 (CBCL/ 6 - 18 version) and 0 to 62 (CBCL/1 ½ - 5 version) and can be converted into standardized scores (e.g., T scores Mean = 50, SD = 10) with higher scores indicating more emotional problems.

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

  2. 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

    The Mini International Neuropsychiatric Interview for Children and Adolescents - Parent Version; (MINI-KID-P) is a structured interview to evaluate the presence of current psychiatric disorders in children (based on ICD-10 and DSM-5). It will be assessed whether or not the criteria for Separation Anxiety Disorder (F93.0), Social Anxiety Disorder (F40.1, F93.2), Specific Phobia (F40.2, F93.1), Generalized Anxiety (F41.1, F93.80) and Obsessive-Compulsive Disorder (F42.2) are currently met (yes/no). The results will be combined to one binary total score 0 (no anxiety disorder) and 1 (current anxiety disorder (criteria for at least one of the anxiety disorders met). 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.

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

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

    Depression, Anxiety, Stress Scales (DASS) will assess parent-report of parental depression, a 21-item scale used as a screening tool to measure depression, anxiety, and stress in adults. Caregivers report on the frequency of symptoms in the previous week using a Likert scale (0 = Never, 1 = Sometimes, 2 = Often, 3 = Always; e.g., "I felt that I had nothing to look forward to"). Total DASS scores range from 0 to 63 with subscales from 0 to 21. Recommended cut-offs indicating severity of depression are 5-6 for mild, 7-10 for moderate, 11-13 for severe, and 14 and up for extremely severe. Cut-offs for anxiety are 4-5 for mild, 6-7 for moderate, 8-9 for severe, and 10 and up for extremely severe. Cut-offs for stress are 8-9 for mild, 10-12 for moderate, 13-16 for severe, and 17 and up for extremely severe. The DASS is a widely used measure across parenting studies including those of PLH 2-9 and will allow comparison to existing results of intervention studies in non-LMICs.

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

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

    The WHO-5 Well-Being Scale (WHO-5) will measure parental psychological well-being. This 5-item scale was derived using psychometric analyses from the longer 28-item WHO Well-Being Scale. The validation study of the WHO-5 showed 93% sensitivity and 64% specificity when compared with the General Health Questionnaire and the Patient Health Questionnaire. Parents indicate the frequency that they experienced well-being in the past month (e.g., "My daily life has been filled with things that interest me") based on a 6-point Likert scale from 0 to 5 ("At no time" to "All of the time"). Items are added up with scores ranging from 0 to 25. The Index was developed in Denmark, is very short and is available in a variety of languages, including Romanian. This scale has also been used in PLH trials in other countries and will allow comparison of results to those studies.

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

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

    Parenting Stress Index-Short version (PSI-SF). The PSI-SF is a brief version (36 items) of the Parenting Stress Index. The PSI has been used extensively in parenting intervention studies and studies investigating mental health in children and their parents. It has three subscales (parental distress, parent-child dysfunctional interaction, and difficult child), and items are scored on a 5-point scale (from strongly agree to strongly disagree). Investigators will not use the Difficult Child scale due to the large overlap with the screening instrument (ECBI) and the Child Behavior Checklist; thus, the number of items used will be 24 in this study. This scale has been used in PLH trials in other countries and will allow comparison of results to those studies.

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

  6. Change in incidence and frequency of child maltreatment: ISPCAN-Child Abuse Screening Tool -Intervention / self-report

    Child maltreatment will be measured using parent report of the ISPCAN Child Abuse Screening Tool-Intervention scale (19 items, ICAST-I), an adaptation of the multi-national and consensus-based ICAST-P. The response code for the ICAST-I was adapted to a scale from 0 to more than 8 times to assess the frequency of a certain behaviour in the past month. This study will use the subscales for physical abuse, emotional abuse and neglect. The incidence of child maltreatment will be assessed by creating dichotomous variables for physical abuse, verbal abuse, and neglect, as well as an overall indication of previous child abuse (0 = no abuse; 1 = previous abuse). Investigators will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale.

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

  7. Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report

    The Parenting Scale (PS) was designed to explicitly measure dysfunctional discipline practices in parents. Three subscales may be derived (Laxness, Overreactivity, and Verbosity). Each item is rated on a 7-point Likert Scale by a parent ranging from 1 to 7. For computation of the subscale scores as well as the total score, the responses on the items are averaged. The range for the three subscale scores and the total score is 1 to 7 with higher scores indicating more dysfunctional parenting. The total score as well as the three subscale scores will be analysed.

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

  8. Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report

    Parenting of Young Children Scale (PARYC). Positive parenting behaviour will be assessed using parent-report of the Parenting of Young Children Scale (PARYC, 21 items). The PARYC measures the frequency of parent behaviour over the previous month. Items are summed to create a total frequency scores parenting behaviour as well as for the subscales: positive parenting (7 items, e.g., "how often do you play with your child"), setting limits (7 items, e.g., "how often do you stick to your rules and not change your mind") and proactive parenting (7 items, e.g., "how often do you explain what you want your child to do in clear and simple ways"). This scale has been used in PLH trials in other countries and will allow comparison of results to those studies.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Jun 2018
  2. Study start26 Apr 2018
  3. Primary completion19 Nov 2018
  4. Study completion2 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
140 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03552250
Sponsor's protocol ID
H2020-779318
Other IDs
H2020-SC1-2017-RTD-779318
Acronym
RISE
Status last verified
Dec 2018
First submitted
16 May 2018
Last updated
4 Dec 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Details will be provided in a Data Management Plan, a deliverable to the European Commission due on June 30th 2018

Publications

  • 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.

    PubMed 39154169
  • 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.

    PubMed 30782760

Questions about this trial

What is this clinical trial studying?

A study testing Parenting for Lifelong Health for Young Children in people with Child Mental Disorder, run by Technische Universitaet Braunschweig at 3 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Moldova, North Macedonia, Romania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in levels of externalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18, parent-report, Externalizing Scale (time frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03552250, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.

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