INFANT HEALTH- Supporting Infants' Mental Health and Healthy Weight Development Through Community Health Nurses' Promoting Sensitive Parenting
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 406
- 试验地点
- 1
- 主要终点
- Social and emotional development
研究概览
简要总结
Mental health problems and overweight often co-occur, they have their origin in early childhood and new research evidence suggest a key role of cognitive, emotional and behavioral regulation in the early developmental trajectories and points to the benefits of intervention in infancy that builds on strategies of sensitive parenting.
The research group behind this project has developed the PUF program (PUF: In Danish: 'Psykisk Udvikling og Funktion') to target infants' mental health and development within the settings of community health nurses. Still, measures are lacking that address the infants most vulnerable regarding the development and progression of mental health problems and overweight.
In this project, we develop and test a new intensified intervention to address major cognitive and regulatory vulnerabilities identified at child age 9-10 months and adapted to the settings of community health nurses. The intervention is created as an add-on to the PUF-program, using an evidence-based method to promote sensitive parenting, the Video-based Intervention to Promote Positive Parenting (VIPP). The new intervention VIPP-PUF comprises six therapeutic sessions delivered by the community health nurse during home visits over a three months period. The intervention builds on teaching the health nurses to promote parents' sensitivity to meet the infants' cognitive and regulatory vulnerabilities, and it takes in account the needs of psycho-socially disadvantaged families.
The Infant Health project is conducted in sixteen municipalities across Denmark. We use the Intervention Mapping approach as the study frame and integrate the best practice of community health nurses. The efficacy of the VIPP-PUF intervention is examined in a randomized controlled step-wedge design, in which approximately 1.000 children are followed up to the age of 24 months.
The VIPP-PUF intervention is hypothesized to reduce mental health problems at ages 24 months among infants with high levels of cognitive and regulatory problems at age 9-10 months, (primary outcome). Also, it is hypothesized that among children with high levels of cognitive and regulatory vulnerabilities at age 9-10 months, adding the VIPP-PUF intervention to treatment as usual at age 9-10 months, will reduce infants' cognitive and regulatory problems; promote healthy weight development; reduce parents' experiences of stress; promote sensitive parenting and promote parents' feeling of competence and relatedness.
详细描述
BACKGROUND Childhood mental health problems and overweight are highly prevalent, and they have severe long-term prognoses regarding mental and physical health, social functioning, and premature death.
The majority of child mental health problems have their origin within the first years of living with increased risk in infants from families of psycho-social disadvantage, and in infants with perinatal adversities and cognitive and psycho-motor difficulties. Problems of eating, sleep, and emotional and behavioral regulation may predict mental health problems and disorders and persistent dysregulation trajectories are associated with emotional- and behavioral problems, eating problems and attention deficit hyperactivity disorder, ADHD. Early parent-child relations and the quality of parenting has a key position in the risk mechanisms.
The risk of overweight is highly increased in children, who are overweight in infancy. Psycho-social risk factors are similar to those of mental health problems, e.g families of psycho-social disadvantage with risk mechanisms including gene-environment interaction, maternal feeding pattern; and higher risk among obese parents to introduce high energy and fat foods very early and having impaired responses to the infant's hunger and satiety cues.
Mental health problems tend to precede the development of overweight in childhood. Potential mechanisms include cognitive vulnerability of inhibitory control/reward, sensitivity and sustained attention, leading to impulsive eating and difficulties in delaying gratification. Infants' problems of emotional regulation and problems of maintaining an affective homeostasis confronted with stress-full experiences may result in emotional eating characterized by pathways of physiological stress responses and reward, in which appetite and attraction to sweet and fatty foods is considered to develop through poor emotional regulation and lower inhibitory control.
Prevention of mental health problems and overweight has to start early and combine universal strategies and targeted interventions to reduce risk exposures, optimize parenting and promote child development and a healthy weight development. The combination of universal approaches and specific intervention to target the most vulnerable children is the most effective way to the reduce the population load of childhood mental health problems and overweight.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 9 Months 至 11 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Three or more PUF problems at the PUF
排除标准
- •Severe mental or physical illness or handicap.
- •Not Danish or English speaking parents
研究组 & 干预措施
Cluster I
Cluster I is randomized to start the VIPP-PUF intervention phase May 1, 2022
干预措施: VIPP-PUF (Behavioral)
Cluster II
Cluster II is randomized to start the VIPP-PUF intervention phase November 1, 2022
干预措施: VIPP-PUF (Behavioral)
Cluster III
Cluster IiI is randomized to start the VIPP-PUF intervention phase March 1, 2023
干预措施: VIPP-PUF (Behavioral)
结局指标
主要结局
Social and emotional development
时间窗: Child age 24 months
The Ages and Stages Questionnaire, Social-Emotional 2 (ASQ: SE2) (version for children aged 1 to 60 months) is used to measure the child's self regulation, compliance, communication and adaptive functioning. It comprises 19 to 33 items rated by parents and includes a box parents in which parents may check if the behavior is a concern for them. The ASQ:SE2 is well-validated and the most commonly used measure of young children's social and emotional development, internationally as well as in Denmark.
Child mental health
时间窗: child age 24 months
The Strengths and Difficulties Questionnaire (SDQ) answered by parents is used at ages 24 months in order to use this very short (25-items) and feasible measure both at age 24 months and at the planned follow-up at older ages. SDQ is highly predictive of persistent child mental health problems and suitable for the prospective investigation of mental health from ages 24 months and onwards. SDQ has been validated for use in children down to the age of 2 years, and used in epidemiological research worldwide, also in Danish populations, with Danish norms being available.
次要结局
- Weight-for-length z-scores(child age 24 months)
- Parenting(Child age 24 months)
- Parental Stress(Child age 24 months)
- Family impairment(Child age 24 months)
- Sensitive parenting(Child age 24 months)
- Eating behaviour and sensitive parenting during meals(Child age 24 months)
- Parental feeding questionnaire(Child ages 18 and 24 months)
- Child eating questionnaire(Child age 24 months)
- Child development progress(Child age 24 months)