Protocol for a Pilot Randomized Trial Assessing the Acceptability, Feasibility, and Initial Efficacy of a Single-session Online Parent-focused Intervention Targeting Predictors of Body Image Disturbance in Young Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Acceptability
研究概览
简要总结
Body image concerns have been linked to diverse mental health issues, including depression and disordered eating. Disordered eating can develop into clinically significant eating disorders, which are associated with serious negative impacts on psychological and physical well-being, and can adversely impact developmental trajectories in children and adolescents. Given limitations in the eating disorder intervention literature, it is important to invest in effective eating disorder prevention programs. Evidence suggests that children can recognize the existence of societal appearance ideals as early as age 3; thus, this study examines the acceptability and feasibility of a single-session, online, parent-focused intervention targeting predictors of body image disturbance in young children.
详细描述
Body image concerns have been linked longitudinally to diverse mental health issues, including disordered eating. Disordered eating can develop into clinically significant eating disorders, which are associated with serious psychological and physical sequelae and can adversely impact developmental trajectories in children and adolescents. The mortality rate associated with eating disorders is second only to that of opiate addiction. Existing treatments for eating disorders remain only moderately effective, with ~40% remission rates for anorexia and bulimia nervosa. It is therefore important to examine early risk factors for the development of body image concerns to inform preventive approaches suitable for intervening early on in the development of disordered eating.
Evidence suggests that children can recognize the existence of societal appearance ideals as early as age 3; in fact, exposure to appearance-focused media at age 3 is prospectively predictive of positive associations with thinness at age 4 and dietary restraint behaviors at age 5. These findings suggest an important role of societal appearance ideals in fostering body discontent and point to the media as a crucial source of communication of these ideals to children. Parents have a great deal, if not all, control over the information their young children are exposed to within the home and from the outside world. The proposed study is based on the assumption that intervening with parents of young children, with a focus on education about the impact of media exposure, can reduce body image disturbance and prevent the future development of disordered eating. Thus, this study explores the acceptability and feasibility of a single-session, online, parent-focused intervention targeting predictors of body image disturbance in young children.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be at least 18 years old and reside in the US. They must also be the parent of a young child between the ages of 2-6.
排除标准
- •None beyond not meeting inclusion criteria.
研究组 & 干预措施
Intervention
In phase 2, 50 participants will be randomized to complete the entire intervention; the intervention/workshop will consist of four modules: Body Image Development/Body Talk, Food Talk, Picky Eating and Mealtime Conversations, and Media Usage and Social Comparison. Each module will be approximately 10 minutes. After parents complete all four modules, they will complete measures of acceptability and feasibility, including reporting which module they found most useful. They will also complete knowledge checks.
干预措施: Child Body Image Development Workshop (Behavioral)
Control
In Phase 2, 50 parents will be randomized into the control group. This group will receive no intervention. They will only complete the knowledge checks. These knowledge checks will be the same checks completed by the intervention group.
结局指标
主要结局
Acceptability
时间窗: Directly after completion of the intervention.
Acceptability will be examined via questions about intervention credibility and expectancy to be completed by workshop participants post-intervention, adapted from the well-establish Credibility and Expectancy Questionnaire (e.g., "At this point, how logical does the intervention seem to you?" "At this point, how successful do you think this information will be in reducing your concerns about your child's eating patterns?").
Recruitment
时间窗: 1 year after study recruitment begins.
Feasibility includes recruitment and retention rates and measurement burden. First, feasibility will be defined as successful recruitment of 50 moms and 50 dads.
Retention
时间窗: At the end of data collection, an average of one year after recruitment begins.
Feasibility includes recruitment and retention rates and measurement burden. Second, feasibility will be defined as retention of 85 % of participants through the entire intervention.
Missingness
时间窗: At the end of data collection, an average of one year after recruitment begins.
In addition, minimal missing data as well as survey items completed will be looked at as measures of feasibility. Less than 5 % of missing data will be required for the study to be considered feasible.
Acceptability
时间窗: Directly after completion of the intervention.
Acceptability will be examined via questions about intervention credibility and expectancy to be completed by workshop participants post-intervention, adapted from the well-establish Credibility and Expectancy Questionnaire (e.g., "At this point, how logical does the intervention seem to you?" "At this point, how successful do you think this information will be in reducing your concerns about your child's eating patterns?").
Recruitment
时间窗: 1 year after study recruitment begins.
Feasibility includes recruitment and retention rates and measurement burden. First, feasibility will be defined as successful recruitment of 50 moms and 50 dads.
Retention
时间窗: At the end of data collection, an average of one year after recruitment begins.
Feasibility includes recruitment and retention rates and measurement burden. Second, feasibility will be defined as retention of 85 % of participants through the entire intervention.
Missingness
时间窗: At the end of data collection, an average of one year after recruitment begins.
In addition, minimal missing data as well as survey items completed will be looked at as measures of feasibility. Less than 5 % of missing data will be required for the study to be considered feasible.
次要结局
- Initial Efficacy(Directly following completion of the intervention.)
- Initial Efficacy(Directly following completion of the intervention.)