Little ACF: A Randomized Controlled Trial on Effects of Universal Parental Group Support Regarding Infants Aged 12-24 Months
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 732
- 试验地点
- 1
- 主要终点
- Change in coparenting relationship from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
研究概览
简要总结
Society can promote children's mental health at an early stage by creating good conditions with, for example, general parental support programs that are offered to all parents. One program that has been developed is called All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] which has been evaluated for parents with children aged 3-12 years. The results showed effects on parenting ability, parenting strategies and on children's well-being. Staff in child health care (CHC), a natural arena for parental support programs reaching almost all families, have requested modifications in the program ACF to involve parents with younger children. The parent groups offered within CHC today are not evaluated in younger children and could be thus replaced by researched parental support based on evidence.
The investigators therefore want to study the effects of a modified version of ACF for parents of children 1-2 years (Little ACF) to see if Little ACF can strengthen parenting ability and have effects on children's social and emotional development. Parents within CHC are asked to participate and are randomly assigned to Little ACF or the regular CHC program plus a lecture. Little ACF is offered during four group meetings and potential effects are measured with questionnaires. Measurements are made before randomisation, during and after participation in Little ACF. Children's behavior is followed up at 3 years through questionnaires and CHC documentation.
The study can provide important knowledge about how Little ACF can promote children's mental health and strengthen parents. The investigators see it as a strength that Little ACF is based on research and on dialogue with parents and professionals. Little ACF, which is aimed at everyone, can form a basis for identifying families and children who need preventive and treatment measures.
详细描述
Promotion of mental health is an important topic and early interventions may be the most cost-effective investment for the society. The Child Health Care (CHC) in Sweden reaches 99% of parents with infants and is the society's major promotive support during the first years of life. All Children in Focus (ACF) [in Swedish: Alla Barn i Centrum (ABC)] is a universal program aiming to support positive parental strategies and promote child well-being. ACF has shown positive effects for parental efficacy and strategies and for child well-being at age 3-12 years. In this 3-year project the investigators aim to gain knowledge about how ACF given to parents with children 1-2 years (Little ACF) may influence parenting and child well-being. Specific research questions are how Little ACF in comparison to care as usual (CAU) within CHC can:
- strengthen strategies of emotional regulation in parents,
- promote parenting practices,
- promote child well-being
- lead to reduction of child behavior problems (externalizing/internalizing),
- engage and retain parents in groups?
Parents with infants of 12-24 months that are registered at any of the included CHC centers in Stockholm, Gotland and mid-Sweden will be asked for participation. Recruitment will be performed at the ordinary 10-, 12- or 18-months visits of the child. The CHC nurse will ask parent/s for participation verbally and parents will be provided the information and consent form and a pamphlet about the study. Parents who are interested in participating will be sent a link via email with the same information and consent form that can be signed digitally. Thereafter they will be sent the questionnaire. When the CHC nurse has recruited twice as many parents as a full Little ACF group, the researchers will randomize the parents into the two groups, one receiving the intervention Little ACF and the other a control group receiving CAU and digital lectures. The CHC nurse will notify the parents about which group they have been randomized to and a description on how the study will proceed.
A previous randomized study of ACF (aimed at parents with children 3-12 years) showed an effect size (Cohen's d) of 0.30 for parental self-efficacy. Since this study compares Little ACF with CAU including lectures (instead of waiting list), a marginally smaller effect (d = 0.25) between the groups is expected. With a significance level of 95% (p-value 0.05) and a power of 80%, it would thus be needed 251 participants in each group. A drop-out rate of 25% is expected, which means that a total of 670 families would need to be included.
Each Little ACF group will consist of parents of 5-7 children, which means that about 60-70 groups will be needed and thus a total of 25 group leader pairs if each pair leads three groups. The pair of group leaders consist of one CHC nurse and one social worker or other profession with experience of working with parents of young children. Group leaders will be provided a training containing theory, practical exercises, and supervision. The training is spread out over three occasions taking place every other week to allow for the possibility to start Little ACF groups in between the training sessions. After the training, the group leaders will be offered monthly group supervision.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Parents of children in the age of 1-2 years that are registered at the CHCs included in the study
排除标准
- •Parents in need of interpreter will be excluded
研究组 & 干预措施
Intervention
Parents included in the intervention group will be offered to participate in four meetings that are taking place during four weeks time. The focus of the meetings is on how to promote parent-infant relationship. The theoretical base is positive developmental psychology including research on attachment, parenting and co-parenting, emotional regulation, and observational learning/role models. Roleplays, video-clips, discussions, and individual reflections are used to empower families during the sessions. Parents are encouraged to try the content with their child between the sessions and will be provided a printed material.
干预措施: Little ACF [in Swedish: Lilla ABC] (Behavioral)
Control
Parents in the control group will via a web-based portal be able to view four pre-recorded lectures during four weeks. The lectures will be around 10 minutes long and have a content similar to the group meetings that are offered to the intervention group but more superficial and without printed material and reflection practices.
干预措施: Lectures (Behavioral)
结局指标
主要结局
Change in coparenting relationship from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
时间窗: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))
Will be measured using 5 items from "The Coparenting Relationship Scale" (Feinberg et al., 2012), to be answered with a 5 point scale from 1=not agree to 5=fully agree
Change in coping with the negative emotions of the child from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
时间窗: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))
Will be measured using "Coping with Toddlers' Negative Emotion Scale" - CTNES (Spinrad et al, 2007), the scale has 12 scenarios with 7 options each on how a parent would react that to that specific scenario (Distress reactions, Punitive reactions, Expressive encouragement, Emotion-focused reactions, Problem-focused reactions, Minimization reactions and Granting wish reactions), the parent are asked to rate how likely s/he is to react in that specific manner from 1 = very unlikely to 7 = very likely, the higher the score the more likely to use that coping mechanism.
Change in parental stress from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
时间窗: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))
Will be measured using the scales (1) incompetence, (2) social isolation and (3) role restriction from the "Swedish Parenting Stress Questionnaire" - SPSQ (Östberg, Hagekull \& Wettergren, 1997), the scale is from 1 to 5 indicating 'Strongly disagree' to 'Strongly agree', the total possible score is 170 and higher scores indicate higher stress.
Change in parental self-efficacy from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
时间窗: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))
Will be measured with the "Tool to Measure Parenting Self-Efficacy" - TOPSE (Bloomfield \& Kendall, 2012), with 48 statements that are to be answered to on a 11 point scale, from 0=not agree to 10=fully agree
Change in parent emotion regulation from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.
时间窗: At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5))
Will be measured with the "Parent Emotion Regulation Scale" - PERS (Pereira et al., 2017). The scale has 20 statements that should be rated on a 5-point scale, from 1=never or almost never to 5=always or almost always.
次要结局
- Psychological and behavioural problems(In relation to the child's visit to CHC at 3 years of age (T5), expected effect at T5)
- Change in childrens' social and emotional development from baseline to four different time points: directly after the intervention, after 6 months, 12 months and when the child is 3 years old.(At five occations: baseline (T1), directly after the intervention (T2), after 6 months (T3), 12 months (T4) and in relation to the child's visit to CHC at 3 years of age (T5), expected effect at T3, T4 and T5)
研究者
Lene Lindberg
Associate Professor in Psychology
Karolinska Institutet