跳至主要内容
临床试验/NCT01802294
NCT01802294
已完成
1 期

Sinovuyo Caring Families Project - Pilot Randomised Controlled Trial of a Parenting Program to Reduce Child Behavior Problems in Xhosa Children Ages 3 to 8 in South Africa

University of Cape Town1 个研究点 分布在 1 个国家目标入组 68 人2013年2月

概览

阶段
1 期
干预措施
未指定
疾病 / 适应症
Child Behavior
发起方
University of Cape Town
入组人数
68
试验地点
1
主要终点
Eyberg Child Behavior Inventory
状态
已完成
最后更新
11年前

概览

简要总结

This pilot feasibility trial will evaluate the Sinovuyo Caring Families Program in a small-scale randomized controlled trial in Cape Town, South Africa (n=60 families). The pilot study will use a mixed-methods approach to intervention evaluation. Self-report and observed quantitative data for intervention and control groups will be collected at pre-test and post-test evaluation. Primary outcomes will include parent-reports and observations of child behavior problems. In addition, as an exploratory study, this phase will examine initial pre-post intervention effects for potential mediating factors of parenting behavior, parental stress, parental depression, and perceived social support. However, this phase will not test mediation effects due to small sample sizes. Quantitative assessments will also collect data on program fidelity, exposure/adherence, participant engagement, and satisfaction. Furthermore, qualitative focus groups with intervention participants and group leaders will examine issues of program feasibility, content, deliver, and satisfaction. Randomization will be done on an individual level and include a wait-list control group that will receive the intervention 3 months after the post-test evaluation. Results from the feasibility pilot study will be shared with intervention partners and advisory groups. If necessary, final program adjustments will be made prior to further testing. Results will also be disseminated to community forums, local organizations, government stakeholders, and via academic conferences.

Research hypotheses:

Hypothesis 1: Children in the intervention group will demonstrate reduced observed and parent-reported child behavior problems in comparison to the control group.

Hypothesis 2: Parents in the intervention group will demonstrate increased observed and self-reported positive parenting outcomes and decreased observed and self-reported harsh and inconsistent parenting outcomes in comparison to the control group.

Hypothesis 3: Parents in the intervention group will demonstrate decreased parental depression and parental stress outcomes and increased perceived social support outcomes in comparison to the control group.

Hypothesis 4: The Sinovuyo Caring Families Program will be implemented with an acceptable degree of program fidelity, exposure/adherence, and participant satisfaction.

注册库
clinicaltrials.gov
开始日期
2013年2月
结束日期
2013年8月
最后更新
11年前
研究类型
Interventional
研究设计
Parallel
性别
All

研究者

责任方
Principal Investigator
主要研究者

Dr Catherine L. Ward

Principal Investigator

University of Cape Town

入排标准

入选标准

  • isiXhosa-speaking adults above the age of 18
  • primary guardians of children aged 3-8 from Khayelitsha, Cape Town
  • reside in the same household as child for at least 4 nights per week
  • Score 11 or more on Eyberg Child Behavior Inventory Problem Scale

排除标准

  • Severe mental health problems on Beck Depression Inventory
  • Evidence of severe child maltreatment

结局指标

主要结局

Eyberg Child Behavior Inventory

时间窗: Change from baseline to 1 week post-program (13 weeks from baseline)

This 36-item examines externalizing behavior problems in children ages 2 to 16 using both an Intensity Scale and Problem Scale. Parents are asked how often a specific behavior occurs and whether the behavior is considered a problem. Based on the most typical child behavior problems, items include "has poor table manners," "acts defiant when told to do something," "physically fights with sisters and brothers," and "fails to finish tasks or project." The Intensity Scale rates frequency of occurrence based on a 7-point Likert scale (1 = never occurs to 7 = always occurs). The Problem Scale measures whether the parent identifies a specific behavior as a problem (0 = no; 1 = yes). Both scales are summed up to create a total Intensity Score and Problem Score. Clinical cut-off scores suggested for psychopathological problem behavior are 131 for the Intensity Score and 11 for the Problem Score (Eyberg, 1999).

Family Observation Scale, 6th Edition

时间窗: Change from baseline to 1 week post-program (13 weeks from baseline)

The FOS-6 measures both consistency and intensity of child and parent behavior. Coding systems use a Likert scale from 0-4 to record whether and how often a particular behavior occurred (0 = behavior did not occur and/or was of low intensity; 4 = occurred a lot and/or was of high intensity). Codes are identified according to different behavioral categories through global and interval coding. Observed parent behavior includes harsh parenting, lax parenting, and praise. Similarly, child behaviors are non-compliance, proactive oppositionality, complaint, and withdrawal. Frequency and intensity scores are calculating by summing the individual scores and then dividing by the total number of observation intervals. Final scores are then calculated from means to generate an overall rating as well as for each subscale (Sanders, 2000).

次要结局

  • Parental Monitoring(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Parent-Child Conflict Tactics Scale (CTSPC) (Straus et al., 1998)(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Parenting Young Children Scale (PARYC)(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Parenting Stress Index-Short Form, Distress Subscale(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Beck Depression Inventory (BDI-II)(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Multidimensional Scale of Perceived Social Support (MSPSS, 12-items)(Change from baseline to 1 week post-program (13 weeks from baseline))
  • Empathy and Personality traits of child(Baseline)
  • Theory of mind(Baseline)
  • Cognitive status(Baseline)

研究点 (1)

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