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Prevention of Child Mental Health Problems in Southeastern Europe (RISE)

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ClinicalTrials.gov Identifier: NCT03552250
Recruitment Status : Completed
First Posted : June 11, 2018
Last Update Posted : December 4, 2018
Sponsor:
Collaborators:
Alpen-Adria-University Klagenfurt
University of Oxford
Bangor University
Babes-Bolyai University
Institute for Marriage, Family and Systemic Practice – ALTERNATIVA, Macedonia
Health for Youth Association, Moldova
University of Cape Town
Georgia State University
Information provided by (Responsible Party):
Prof. Dr. Nina Heinrichs, Technische Universitaet Braunschweig

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).


Condition or disease Intervention/treatment Phase
Child Mental Disorder Behavioral: Parenting for Lifelong Health for Young Children Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prevention of Child Mental Health Problems in Southeastern Europe - Adapt, Optimize, Test and Extend Parenting for Lifelong Health
Actual Study Start Date : April 26, 2018
Actual Primary Completion Date : November 19, 2018
Actual Study Completion Date : December 2, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Parenting for Lifelong Health
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
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.
Other Name: PLH Programme




Primary Outcome Measures :
  1. 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 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.

  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 [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.


Secondary Outcome Measures :
  1. Change in levels of internalizing problem behavior in children: Child Behavior Checklist (CBCL) 11/2-5 and 6-18 parent-report, Internalizing Scale [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  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 [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  3. Change in levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  4. Change in levels of parental well-being: WHO-5 Well-Being Scale/ self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  5. Change in levels of parental stress: Parenting Stress Index - Short Form (PSI-SF) / self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  6. Change in incidence and frequency of child maltreatment: ISPCAN-Child Abuse Screening Tool -Intervention / self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  7. Change in frequency of dysfunctional parenting: Parenting Scale (PS) / self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.

  8. Change in frequency of positive parenting and effective discipline: Parenting of Young Children Scale (PARYC) / self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    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.


Other Outcome Measures:
  1. Change in levels of Intimate Partner Violence: Adapted Revised Conflict Tactics Scale-Short Form [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    Intimate partner violence will be assessed with a screening instrument, which is an adaption of the revised Conflict Tactics Scale (CTS2S). The CTS2S assesses adult self-report of exposure to intimate partner physical and psychological aggression. Assessments measure the frequency of negotiation, physical assault, psychological aggression, and physical injury. Answers are coded on a 5-point Likert scale of 0 to 4 (0 = never happened; 4 = more than 3 times in the past month), with an additional response for incidences that happened but not in the past month. This measure indicates an overall indication of IPV on a level of severity (sum of items) and prevalence (dichotomous variable indicating experience of conflict or not) as well as for each subscale.

  2. Change in levels of family functioning, Family assessment device Short form [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    Family Assessment Device Short Form. The 12 item short form of the Family Assessment Device (FAD, General functioning) will be used to assess family functioning. The FAD is one of the most widely used instruments to assess overall family functioning. For computation of the total score, the responses on each item (ranging from 1 to 4) are averaged. Thus, the total score ranges from 1 to 4 with higher scores indicating greater family pathology.

  3. Change in levels of parental relationship quality: Kansas Marital Satisfaction Scale [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    Kansas Marital Satisfaction Scale. This 3 item measure assesses relationship satisfaction among intimate partners. This scale has been widely used and correlates highly with other measures of relationship satisfaction (e.g., Dyadic Adjustment Scale, Quality of Marriage Index). Items are rated on a scale from 1 (extremely dissatisfied) to 7 (extremely satisfied). High internal consistency, discriminant validity, and concurrent validity have been demonstrated in other studies.

  4. Change in levels of social community support, MOS Social Support Survey - Emotional Support Subscale, self-report [ Time Frame: Pre-Post (approximately 16 - 20 weeks after pre-assessment) ]
    MOS-Social Support Survey. Perceived social support will be measured using the emotional support subscale of the Medical Outcome Study Social Support Survey (MOS-SSS, 8-items). In validation studies this scale has shown excellent internal consistency (α = 0.91 to 0.97) and test-retest reliability (α = 0.72 to 0.78). Parents report on the frequency of how often they receive emotional support (e.g., "someone you can count on to listen to when you need to talk") on a Likert-like scale of 1 to 5 (1 = none of the time; 5 = all of the time). Total scores are calculated by averaging the scores for each item and then transformed into a 0 to 100 scale. The scale was found to be distinct from related health measures, which is important for the present study.

  5. RE-AIM Reach: Recruitment rate [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Number of families who were eligible for inclusion and provided consent to participate in the program divided by the number of target population who were exposed to recruitment activities

  6. RE-AIM Reach: Enrollment rate [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Number of families who attend at least one session of the program divided by the number of families recruited into the program

  7. RE-AIM Reach: Participation rate [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Mean attendance rate for program sessions based on those families who enrolled in the program (i.e., parents who attended at least one session). Percentage of families who enrolled in the program who attended 50% (e.g., 6 sessions) and 75% (e.g., 9 sessions) or more.

  8. RE-AIM Implementation Dosage in hours [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Average number of hours delivered by facilitators (time for pre-program consultation plus session plus phone consultations per participant, facilitator report verified by implementation monitors)

  9. RE-AIM Implementation Dosage (points of contact) [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Total number of points of contact by facilitators

  10. RE-AIM Implementation Fidelity (percentage of session activities delivered per session) [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Percentage of number of session activities delivered by facilitators (by facilitator group, implementing agency, and participating country site; facilitator fidelity check-list reports verified by implementation monitors and random video recordings of session delivery)

  11. RE-AIM Implementation Fidelity (mean percent of activities delivered per session) [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    Average number of activities delivered divided by total number of activities per session (by facilitator group, implementing agency, and participating country site; facilitator reports verified by implementation monitors and random video recordings of session delivery)

  12. RE-AIM Implementation Quality [ Time Frame: Post (after 12 sessions; approximately 10-12 weeks after pre-assessment) ]
    The implementation quality is assessed using the PLH-Facilitator Assessment Tool (PLH-FAT): Seven standard behaviour categories are grouped into two scales based on the core activities and process skills. Assessment of core activities includes quality of delivery during home activity review, illustrated story discussions, and practicing skills with scores from 0 (inadequate) to 3 (exceeds expectations). Assessment of process skills includes modelling skills, collaborative facilitation approach, encouragement of participation, and leadership skills (scoring from 0 = inadequate to 3 = outstanding). The total scores oft both subscales range from 0 to 72 with higher scores indicating higher facilitator competency. The total percent score for both subscales will be calculated (total score / total possible score) x 100%. A higher percent score indicates higher implementation quality.

  13. Participants observed change in parenting practices and child behaviour at home during program [ Time Frame: Post (approximately 16 - 24 weeks after pre-assessment) ]
    Qualitative in-depth interviews with intervention participants and focus groups with the facilitators in order to explore program acceptability. Participants will be purposively selected based on those with high attendance (>75%), those with low attendance (<25%), those who dropout, and those who do not enroll.

  14. Acceptability and appropriateness of program materials, delivery, and key program components [ Time Frame: Post (approximately 16 - 24 weeks after pre-assessment) ]
    Qualitative in-depth interviews with intervention participants and focus groups with the facilitators. Participants will be purposively selected session based on those with high attendance (>75%), those with low attendance (<25%), those who dropout, and those who do not enroll.

  15. Existing barriers to participation during sessions and engagement in home practice and other activities [ Time Frame: Post (approximately 16 - 24 weeks after pre-assessment) ]
    Qualitative in-depth interviews with intervention participants and focus groups with the facilitators in order to explore program acceptability. Participants will be purposively selected from the intervention group with the inclusion criteria of attending at least one intervention session. Selection will be based on those with high attendance, those with low attendance, those who dropout, and those who do not enroll.

  16. Challenges in implementing the program [ Time Frame: Post (approximately 16 - 24 weeks after pre-assessment) ]
    Qualitative focus group discussions with the facilitators exploring challenges in implementing the program on a process (e.g., using a collaborative approach and/or explaining concepts such as child led play) and logistical level (e.g., recruitment, session length, location, meals).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 he/she chooses to be part of the study (based on the Eyberg Child Behavior Inventory);
    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 to participate in the PLH 2-9 program;
    6. Provision of Informed consent to participate in the full stud

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03552250


Locations
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Macedonia, The Former Yugoslav Republic of
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA
Skopje, Macedonia, The Former Yugoslav Republic of, 1000
Moldova, Republic of
Health For Youth Association
Chisinau, Moldova, Republic of, MD2020
Romania
Babes Boylai University
Cluj-Napoca, Romania, 400084
Sponsors and Collaborators
Technische Universitaet Braunschweig
Alpen-Adria-University Klagenfurt
University of Oxford
Bangor University
Babes-Bolyai University
Institute for Marriage, Family and Systemic Practice – ALTERNATIVA, Macedonia
Health for Youth Association, Moldova
University of Cape Town
Georgia State University
Investigators
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Principal Investigator: 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
Principal Investigator: Catherine Ward, Prof. University of Cape Town
Principal Investigator: Xiangming Fang, Prof. Georgia State University

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Prof. Dr. Nina Heinrichs, Technische Universitaet Braunschweig
ClinicalTrials.gov Identifier: NCT03552250     History of Changes
Other Study ID Numbers: H2020-779318
H2020-SC1-2017-RTD-779318 ( Other Grant/Funding Number: European Commission )
First Posted: June 11, 2018    Key Record Dates
Last Update Posted: December 4, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details will be provided in a Data Management Plan, a deliverable to the European Commission due on June 30th 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Prof. Dr. Nina Heinrichs, Technische Universitaet Braunschweig:
Parenting Program
Additional relevant MeSH terms:
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Mental Disorders
Neurodevelopmental Disorders