跳至主要内容
临床试验/NCT05760820
NCT05760820招募中不适用

SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce

University of Copenhagen2 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
1,000
试验地点
2
主要终点
Mental health and Well-being in Everyday Life - Scale sum score

研究概览

简要总结

The overall aim of the SES Children (SES Mini/SES Nxt) - A Digital Intervention for Children of Divorce project is to develop the digital online intervention "SES Children (SES Mini & SES Nxt)", and test whether it reduces well-known negative consequences of divorce and major life crises among children and adolescents by employing a longitudinal RCT study design. SES Children (SES Mini & SES Nxt) is a digital intervention platform that seeks to develop the self-efficacy and ability of children to overcome the challenges that may come with a divorce and major life crises, thereby reducing the negative impacts of these on children's overall mental health and wellbeing. SES Children (SES Mini & SES Nxt) is a first of its kind and differs from existing interventions aimed at children in four crucial ways: 1) by being a comprehensive online intervention accessible via PC, smartphone, and tablet; 2) by being research-based and developed with the ambition of later scientific testing of its effect; 3) by offering early intervention to all children who experience parental divorce - not just children experiencing problems or conflicts in connection with parental divorce or who belong to certain age groups, and; 4) through its format and design, the intervention is adaptive to the individual child's needs and age and focuses on establishing real and lasting self-efficacy and behavioral change rather than only being informative and psycho-educational. Thus, unique to the solution are also unique methodological advances and knowledge related to digital interventions for children.

详细描述

The SES Children (SES Mini/SES Nxt) project consists of two main stages: 1) Development of the digital intervention, SES Children (SES Mini & SES Nxt), and 2) Testing the intervention.

Stage 1: The digital intervention has been developed. The content of the intervention is based on the research in child psychology and the factors suggested to be central to children's mental health and well-being (e.g., agency, prosociality, connection, normalization, and mentalization) as well as on the experiences and needs of professionals in the field. Specifically, collaboration with the Agency of Family Law was established, and the agency is considered the primary stakeholder in the field. The material was digitally implemented by experts in the field of digital learning.

Stage 2: The aim of the second stage is to assess the efficacy of the intervention in improving children´s study's primary and secondary outcomes. The intervention will be tested using a mixed-method design, including both a quantitative and a qualitative study methodology. This will take place in collaboration with the Agency of Family Law and Danish municipalities. Specifically, families will be invited to participate in the study by e-mail through the Agency of Family Law, Danish municipalities, and social media outreach. Individuals will receive an invitation letter, containing a short explanation of the study and a link to the study website, which contains a more thorough information sheet, eligibility questions, and an consent form.

The intervention will be evaluated using a two-armed, online, longitudinal randomized controlled trial (RCT), comparing an intervention group and a waitlist control group. Prior to baseline, participants will be randomized (1:1) to either the intervention group or the control group. Randomization will occur at the family-level, such that all members of the same family (the parent and the children that are signed up for study participation) will be in the same group. All participants will be asked to complete questionnaires at study inclusion (baseline), and at 1- and 3-months post baseline. Parents will be asked to respond to baseline questions covering basic socio-demographic variables and the outcome questionnaire. Parents will respond on behalf of children under the age of 11 (that is, we will obtain parent-report on children aged 3-10), while children aged 11 and older will respond to questions without parental assistance, as specified in the manual instructions for the outcome measures. Randomization will be blinded for the participant only until after the completion of the baseline questionnaire. After completion of the baseline questionnaires, those in the intervention group will gain immediate access to the digital intervention, while those in the control group will gain access after the 3-month follow-up questionnaire. The qualitative part of the evaluation will be conducted using semi-structured interviews with children and parents; these interviews will occur after the 1-month follow-up questionnaire.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
3 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • be a custodial parent of at least one child between 3-17 year of age;
  • be previously married and divorced or in a partnership and separated;
  • have internet access;
  • be able to write and read Danish.

排除标准

  • not having a custodial child between 3-17 years of age.

结局指标

主要结局

Mental health and Well-being in Everyday Life - Scale sum score

时间窗: 3 months

The Strength and Difficulty Questionnaire (SDQ) is used to assess mental health and well-being in everyday life among children and adolescents and has been found to be predictive of psychological and social functioning and (mal)adjustments in both the short term and in the longer run. The SDQ consists of 25 items that fall into five subscales: 1) Emotional symptoms, 2) Conduct problems, 3) Hyperactivity/inattention, 4) Peer relationships problem, and 5) Prosocial behavior. Items are rated on a 3-point scale, with response options being "not true" (0), "somewhat true" (1), and "certainly true" (2). A total difficulties score is generated by summing scores from all the scales except the prosocial scale. The resultant score ranges from 0 to 40, with higher score, indicating more mental health and well-being related difficulties. The scale has been validated and normed to Danish children and adolescents aged 2-17 and has been used in numerous Danish and international studies.

Mental health and Well-being in Everyday Life - Impact score

时间窗: 3-months

The Strength and Difficulty Questionnaire (SDQ) is used to assess mental health and well-being in everyday life among children and adolescents. The SDQ contains an impact scale that assesses whether parents and children believe that the child has difficulties (in the areas of emotions, concentration, conduct, or social interactions), and if so, whether those difficulties interfere with the child's everyday life in terms of home life, friendships, classroom learning, and leisure activities. The impact supplement consists of 5 questions that are rated on a 4-point scale, with response options being "not at all" (0), "only a little" (0), "a medium amount" (1), and "a great deal" (2). The items are summed, and the resultant score can range from 0 to 10, with higher scores indicating greater impact of problems on daily life.

Mental health and Well-being in Everyday Life - Emotional symptoms / problems

时间窗: 3 months

Strength and Difficulty Questionnaire (SDQ) The Strength and Difficulty Questionnaire (SDQ), emotional symptoms subscale, is the primary outcome. The subscale consists of 5 items that are rated on a 3-point scale, with response options being "not true" (0), "somewhat true" (1), and "certainly true" (2). The score is obtained by summing (appropriately reverse-scored) items together; scores can range from 0 to 10. Higher subscales scores indicate greater problems. The scale has been validated and normed to Danish children and adolescents aged 2-17 and has been used in numerous Danish and international studies (see also http://sdq.dk).

次要结局

  • Mental health and Well-being in Everyday Life - Conduct problems(3 months)
  • Mental health and Well-being in Everyday Life - Hyperactivity/inattention(3 months)
  • Mental health and Well-being in Everyday Life - Peer relationships(3 months)
  • Somatization(3 months)
  • Body size perception(3 months)
  • Mental health and Well-being in Everyday Life - Prosocial Behavior(3 months)
  • Quality of Life - The QoL VAS(3 months)
  • Sleep quality - difficulty falling asleep(3-months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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