NCT03865485|CompletedDMC

Prevention of Child Mental Health Problems in Southeastern Europe (RISE) - A Factorial Study (Phase 2 of MOST)

RISE

RISE- Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health - A Factorial Study (Phase 2 of MOST)

University of Bremen ClinicalTrials.gov

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2 other identifiers

H2020-779318H2020-SC1-2017-RTD-779318

Study Type

interventional

Target

835

Locations

3 countries

Sites

Timeline

RegisteredMar 2019

StartedMar 2019

CompletionMay 2020

Brief Summary

The aim of this study is to optimize an adapted version of a parenting program, Parenting for Lifelong Health for Young Children (PLH), to meet the specific needs of families in three low- and middle-income countries in Southeastern Europe (Romania, FYR of Macedonia and Republic of Moldova) using a cluster factorial experimental design to select the most efficacious, cost-effective, and scalable intervention components. This study is the second phase of a three-phase research project (www.rise-plh.eu). The cluster factorial experiment will examine the effectiveness, cost-effectiveness, and implementation of three selected components of the PLH for Children program to inform the selection of the most effective, cost-effective, and implementable components to include in a prevention package prior to testing it in a subsequent RCT. The cluster factorial experiment will be conducted across three Southeastern European country sites. Each site will recruit families with children aged two to nine years who have elevated levels of child behavior problems, including specifically high-risk groups, such as minorities (e.g. Roma families). Program facilitators will be recruited from local agencies and schools. The factorial experimental trial will randomize 16 clusters in each country to one of 8 experimental conditions which consist of any combination of the three components (program length: 5 sessions/10 sessions; engagement booster: high/low; fidelity booster: high supervision/low supervision). The purpose of this factorial experiment is to estimate the main effects of the three intervention components and interactions between the components. At the end of the cluster factorial experiment, we will develop an optimized version of the program by selecting components or component levels that have the highest level of effectiveness as based on effect size (rather than p-values). We will also take into consideration factors regarding cost-effectiveness and implementation outcomes when designing this optimized intervention package.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

835

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Mar 2019

Geographic Reach

3 countries

3 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

First Submitted

Initial submission to the registry

February 25, 2019

Completed

4 days until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed

6 days until next milestone

First Posted

Study publicly available on registry

March 7, 2019

Completed

1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 10, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2020

Completed

Last Updated

May 19, 2020

Status Verified

April 1, 2020

Enrollment Period

1.2 years

First QC Date

February 25, 2019

Last Update Submit

May 18, 2020

Conditions

Child Mental Disorder

Keywords

Parenting Program

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" (from the Externalizing Scale)
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 2, 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. In addition to the possibility to separate behavioral from emotional symptoms, the CBCL allows for assessment in multiple languages, including Romanian, Russian, and Macedonian. The externalizing subscale raw score ranges from 0 to 48 (CBCL½-5) and 0 to 70 (CBCL6-18) with higher scores indicating more problems. The aggressive behavior subscale belongs to the externalizing scale and assess aggressive behavior (e.g., "Argues a lot"; ; raw score ranges from 0 to 38 in the CBCL ½ - 5 version and 0-36 in the CBCL 6-18 version). 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; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report (shortened version); total score
This measure is widely used in parenting interventions across the world. The scale was designed to explicitly measure dysfunctional discipline practices in parents. Three subscales may be derived (Laxness, Overreactivity, and Verbosity). For phase 2, the subscale Verbosity is excluded due to poor performance in the pilot study, consistent with numerous other studies evaluating this subscale's psychometric properties. Each item is rated on a 7-point Likert Scale in which parents are presented with a situation and then are asked to choose between two alternative responses to a situation (1 = most effective; 7 = most ineffective; i.e., situation: "When I say my child can't do something"). For computation of the subscale scores as well as the total score, the responses on the items are averaged. We will use a modified total score (only from two subscales Laxness \& Overreactivity).
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report (21 items); continuous total score
Positive parenting behavior will be assessed using parent-report of the Parenting of Young Children Scale (PARYC, 21 items). The PARYC measures the frequency of parent behavior over the previous month. Items are summed to create a total frequency scores parenting behavior 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.
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)

Secondary Outcomes (6)

Change in level of internalizing problem behavior 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; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report (21 items); continuous total score
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Change in frequency and incidence of child maltreatment: ISPCAN-Child Abuse Screening Tool-Intervention / self-report (16 items); main focus on continuous total score, 2nd question: any effect of intervention on any of the 3 sub-scale scores?
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
RE-AIM Implementation: Quality
post: approx. 7 months after pre assessment (September/October 2019)
RE-AIM Reach: Enrolment rate
post: approx. 7 months after pre assessment (September/October 2019)
+1 more secondary outcomes

Other Outcomes (9)

Change in levels of Intimate Partner Violence (29 items); continuous total score and 4 sub-scales (level of severity)
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Change in levels of parental relationship quality: Couple Satisfaction Index / self-report (4 items); continuous total score
pre; post: approx. 7 months after pre assessment (September/October 2019); follow-up: approx. 11 months after pre assessment (January/February 2020)
Child and Adolescent Behavior Inventory (CABI), oppositional defiant disorder subscale (9 items)
Pre (before start of intervention)
+6 more other outcomes

Study Arms (8)

Length: long; Engagement booster: high; Fidelity booster: high

EXPERIMENTAL

Behavioral: Parenting for Lifelong Health (PLH) 1. Program length - long: 10 group sessions of the PLH 2-9 intervention delivered every other week (i.e., relationship building, positive reinforcement, setting limits, and effective discipline); 2. Engagement booster - high: Engagement Boosters (i.e., a communication booster including weekly text messages reminders and 5-minute phone consultations twice a month from facilitators and an enhanced incentives package (including lunch (approx. 1-3€), a food parcel (approx. 2 - 5 €), reimbursement for local transport (FYR of Macedonia and Republic of Moldova only) at each group session and an award for attendance (if parents did not miss more than 1 session, approx. 5-20€) and raffle prizes at the end of the program), 3. Fidelity booster - high supervision: Fidelity Boosters (i.e., 5 structured intensive video feedback supervision sessions for facilitators).