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임상시험 NCT04721730 (RISE)은(는) 아동 정신 장애에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요.
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰

Prevention of Child Mental Health Problems in Southeastern Europe - Phase 3 (RISE) 823 예방

완료
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT04721730 (RISE)은(는) 아동 정신 장애에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2020년 12월 7일에 시작되어 823명의 참여자와 함께 진행되었습니다. University of Bremen이(가) 진행한 이 연구는 2022년 3월 14일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2022년 3월 22일에 갱신되었습니다.
간단한 개요
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 p...더 보기
상세한 설명
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 emerg...더 보기
공식 제목

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)

질환명
아동 정신 장애
출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.
기타 연구 식별자
  • RISE
  • H2020-779318-3
  • H2020-SC1-2017-RTD-779318 (기타 보조금/자금 번호) (European Commission)
NCT 번호
실제 연구 시작일
2020-12-07
최신 업데이트 게시
2022-03-22
예상 연구 완료일
2022-03-14
계획된 등록 인원
823
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Parenting Programme
주요 목적
예방
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
단일맹검
시험군 / 개입
참가자 그룹/시험군개입/치료
실험적PLH-YC
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 o...더 보기
PLH-YC
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: Reflecti...더 보기
활성 대조군Lecture
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 (...더 보기
강의
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.
주요결과변수
결과변수측정값 설명시간 범위
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
이차결과변수
결과변수측정값 설명시간 범위
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
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 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. In addition to the possibility to separate behavioral from emotional symptoms, the CBCL allows for assessment in multiple languages, including Romanian (all ages), Russian (all ages), and Macedonian (6-18 version). It is a very well validated instrument that has been used across different prevention and treatment studies. The internalising subscale raw score ranges from 0 to 62 (CBCL/1 ½ - 5 version) and 0 to 64 (CBCL/ 6 - 18 version) with higher scores indicating more emotional problems.
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
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 3, 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: 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
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 behaviour over the previous month. Items are summed to create a total frequency scores parenting behaviour as well as for the sub-scales: 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: 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
We will use 5 items from the Alabama Parenting Questionnaire phone interview (3 items for positive and 2 for negative parent behaviours) to assess daily reports of parenting behavior. The original answer format was adapted to fit the PDR format (0=did occur/1=did not occur). One overall mean score will be calculated (ranging from 0 to 1) with higher scores indicating more effective parenting behaviour (ineffective parenting items will be reverse-scored).
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
The FMSS assesses the caregiver's attitudes and feelings about the child and his/her perceptions of the quality of their relationship. The parent is instructed to talk about his/her child for five minutes. The parent-report is audio-recorded and rated by trained coders. The overall coherence scale ranges from 1 (not coherent picture of child) to 7 (very coherent picture of child) with higher scores indicating a more coherent narrative which indicates a better parent-child relationship. If inter-rater reliability of sub-scales is fair enough (ICC of .70 or higher), additional exploratory analyses will comprise the sub-scales concern / worry (1 "no worry and concern" to 7 "thematic concern and worry"), acceptance and warmth vs. rejection (1 "strong rejection" to 7 "high warmth and acceptance"), and separateness (1 "no clear separation" to 7 "complete separateness"; incl. boundary dissolution (BD) answer format: 0, 1, 2 with higher scores indicating more BD).
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-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
The FMSS assesses the caregiver's attitudes and feelings about the child and his/her perceptions of the quality of their relationship. The parent is instructed to talk about his/her child for five minutes. The parent-report is audio-recorded and rated by trained coders. Parents are rated using two sub scales of the FAARS on 9-point Likert items ranging from 1 "no evidence for the duration of the speech sample" to 9 "two or more concrete, unambiguous examples of a particular behaviour or attribute" on each of 5 items per sub scale. Sub scale scores (mean of items): For the Criticism sub scale, higher scores indicate more negative attitudes (and thus a lower parent-child relationship quality); while higher scores on the Warmth sub scale indicate more positive attitudes (and thus a better relationship quality).
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 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
Child maltreatment (CM) will be measured using parent report of the ICAST-I, an adaptation of an instrument measuring parent-report of child abuse and neglect (ICAST-TC, Trial Children). The ICAST-TC measures four types of abuse: physical, emotional and sexual abuse, as well as neglect. The response code 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 assess incidence of CM by creating dichotomous variables for physical abuse, verbal abuse, and neglect, as well as an overall indication of previous child abuse. We will also assess frequency of overall abuse by summing all of the subscales as well as for each individual subscale. Regarding emotional abuse, a 5-item-version is used. Sexual abuse is not assessed. If assessments cannot take place in-person (due to COVID-19 restrictions), this measure will not be administered during the phone assessment because of the sensitive nature of items.
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 levels of psychological distress in parents: Depression, Anxiety, and Stress Scales - short version/ self-report (21 items); continuous total score
Depression, Anxiety, Stress Scales (DASS) will assess parent-report of psychological distress in parents, 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. The DASS is a widely used measure across parenting studies including those of PLH-YC and will allow comparison to existing results of intervention studies in non-LMICs.
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 levels of parenting stress: Parenting Stress Scale (18-items); continuous total score
The Parental Stress Scale measures parental stress across different domains (rewards, stressors, satisfaction, loss of control) with 18 items. An example, from the domain stressors, is "The major source of stress in my life is my child(ren)". Caregivers answer on a scale from strongly disagree (1) to strongly agree (5). The overall score ranged from 18 to 90 with higher scores indicating more parental stress.
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 levels of parental relationship quality: Couple Satisfaction Index / self-report (4 items); continuous total score
This 4-item measure assesses relationship satisfaction among intimate partners. Items are summed to create a total score. CSI-4 scores can range from 0 to 21. Higher scores indicate higher levels of relationship satisfaction. CSI-4 scores falling below 13.5 suggest notable relationship dissatisfaction.
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 levels of Intimate Partner Violence (29 items); continuous total score and 4 sub-scales (level of severity)
Intimate partner violence will be assessed with a screening instrument, the family maltreatment measure (Heyman et al. 2013) and an adaption of the revised Conflict Tactics Scale (CTS2S). The measure assesses adult self-report of perpetration and victimisation of intimate partner aggression. Assessments measure the frequency of negotiation, physical assault, psychological aggression, and physical injury. 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. Only severity is examined here. For the current study a 9-point Likert scale of 0 to 8 is used, with an additional response for incidences that happened but not in the past month. If assessments cannot take place in-person (due to COVID-19 restrictions), this measure will not be administered during the phone assessment.
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 Child Quality of Life: Child Health Utility 9D (CHU9D; 9 items); continuous total score
The CHU9D measures parent-reported child health-related quality of life. The questionnaire consists of nine dimensions (worried, sad, pain, tired, annoyed, schoolwork/homework, sleep, daily routine, activities) with five levels (e.g., 1 = "don't feel worried"; 5 = "very worried"). Higher scores indicate lower levels of quality of life. The scores of the CHU9D range from 9-45.
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)
RE-AIM Reach: Enrollment rate
Total number of caregivers who attend the first session of the PLH/ the lecture group divided by the number of families recruited in that condition).
approx. 4 months after pre-assessment (May/June 2021)
RE-AIM Reach: Participation rate
Only for caregivers that were allocated to the PLH condition: percentage of sessions attended out of the 5 sessions
approx. 4 months after pre-assessment (May/June 2021)
적격성 기준

연령대
성인, 노인
최소 연령
18 Years
참여 가능한 성별
전체
  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).

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.
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연락처 정보가 없습니다.
3 3개국에 임상시험 장소

MD

Health for Youth Association, Chisinau, MD, 2020, Moldova
Institute for Marriage, Family and Systemic Practice - ALTERNATIVA, Skopje, 1000, North Macedonia
Babes Boylai University, Cluj-Napoca, 400084, Romania