■踏石三重P是一种适应性干预措施,适用于患有发育障碍的幼儿的父母,他们表现出挑战的行为,旨在教授积极的育儿技巧和促进积极的亲子关系。
■评估4级步进石TripleP在减少中度至重度智力障碍儿童挑战行为方面的临床和成本效益。
■一项平行的双臂实用多位点单盲随机对照试验共招募了261个二元组(父母和孩子)。这些孩子的年龄为30-59个月,患有中度至重度智力障碍。参与者被随机分组,使用3:2的分配比例,进入干预臂(台阶石三重P;n=155)或照常治疗臂(n=106)。参与者来自布莱克浦的四个研究中心,伦敦北部和南部和纽卡斯尔。
■4级SteppingStonesTripleP包括6个小组会议和3个单独的电话或面对面接触,为期9周。由于2019年冠状病毒疾病大流行,这些会议在2020年3月16日之后更改为远程会议。
■主要结果指标是父母报告的儿童行为清单,评估挑战行为的严重性。
■我们发现干预组的平均儿童行为清单得分(-4.23,95%CI-9.98至1.52,p=0.146)与12个月时的常规治疗相比,差异很小。根据方案和编译器的平均因果效应敏感性分析,考虑到参加会议的次数,显示12个月时儿童行为清单平均得分差异在干预组降低了-10.77(95%CI-19.12至-2.42,p=0.014)和-11.53(95%CI-26.97至3.91,p=0.143),分别。在2019年冠状病毒疾病大流行之前和之后招募的参与者之间的儿童行为清单平均得分差异估计为-7.12(95%CI-13.44至-0.81)和7.61(95%CI-5.43至20.64),分别(p=0.046),这表明,大流行前的任何影响都可能在大流行期间逆转。所有次要指标均无差异。踏石三重P可能物有所值(-1057.88英镑;95%CI-3218.6英镑至-46.67英镑),但是,作为现有育儿干预措施或照常治疗的替代方案的决定可能取决于政策制定者是否愿意投资于早期干预措施以减少具有挑战性的行为。家长报告说,干预提高了他们的信心和技能,组格式使他们能够向他人学习并从同行支持中受益。研究期间报告了20起严重不良事件,但没有一个与干预有关。
■步进石三重P臂的出勤率很低,以及2019年冠状病毒疾病与招募和实施干预措施相关的挑战。
■4级踩踏石TripleP并没有减少对患有中度至重度智力障碍的非常年幼的儿童的早期发作行为。然而,对于那些接受足够剂量干预的人来说,对儿童行为有影响.有一个很高的可能性,踏石三重P至少是成本中性的,因此值得考虑作为一个早期的治疗选择,因为对人和他们的社交网络的挑战的行为的长期后果。
■进一步的研究应该调查在这个人群中挑战行为的实施情况,以及最大限度地提高参与度和后续成果的最佳交付模式。
■本研究注册为NCT03086876(https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis±Angela&draw=1&rank=1)。
■该奖项由美国国家卫生与护理研究所(NIHR)卫生技术评估计划(NIHR奖参考:HTA15/162/02)资助,并在《卫生技术评估》中全文发布。28号6.有关更多奖项信息,请参阅NIHR资助和奖励网站。
研究表明,在没有学习障碍的儿童中,支持父母发展技能来管理挑战孩子的行为的育儿小组可能会有所帮助。国家健康与护理卓越研究所建议,需要更多的研究来加强对中度至重度学习障碍儿童的干预措施的证据,这些儿童更有可能在英格兰表现出挑战的行为。在这项研究中,我们在现实条件下测试了一个名为4级步进石TripleP的程序,在英国以外的试验中显示出积极的结果。经过培训的治疗师在9周内为30-59个月患有中度至重度学习障碍的儿童的父母提供了6个小组和3个单独的课程。偶然(随机)将二百六十一位父母分配到两个手臂中的一个:一个接受了SteppingStonesTripleP和照常治疗,另一个仅照常治疗。通常的治疗包括全科医生或社区儿童发展团队的支持和建议。我们的主要结果是随机分组后12个月父母报告的儿童行为。我们还收集了其他结果的数据,并与父母进行了访谈,服务经理和治疗师了解他们对垫石三重P的看法。我们没有发现垫石三重P在12个月时比平常的治疗更能减少儿童的挑战行为。然而,当我们看到接受了一半以上会议的人时,行为的减少幅度更大,这表明,如果他们参加完整的计划,则踩石三重P对家庭有效。踏石三重P似乎物有所值,正如我们发现的那样,在12个月时(涵盖10个月的费用),从健康和社会护理的角度来看,垫石三倍P的费用比通常的治疗低1058英镑。因此,垫脚石三重P是相当便宜的交付和适当的早期干预行为的挑战,特别是由于积极的反馈,从父母。在整个审判过程中,我们包括一个家长咨询小组,负责监督学习材料,面试主题指导和研究推广。
UNASSIGNED: Stepping Stones Triple P is an adapted intervention for parents of young children with developmental disabilities who display behaviours that challenge, aiming at teaching positive parenting techniques and promoting a positive parent-child relationship.
UNASSIGNED: To evaluate the clinical and cost-effectiveness of level 4 Stepping Stones Triple P in reducing behaviours that challenge in children with moderate to severe intellectual disabilities.
UNASSIGNED: A parallel two-arm pragmatic multisite single-blind randomised controlled trial recruited a total of 261 dyads (parent and child). The children were aged 30-59 months and had moderate to severe intellectual disabilities. Participants were randomised, using a 3 : 2 allocation ratio, into the intervention arm (Stepping Stones Triple P; n = 155) or treatment as usual arm (n = 106). Participants were recruited from four study sites in Blackpool, North and South London and Newcastle.
UNASSIGNED: Level 4 Stepping Stones Triple P consists of six group sessions and three individual phone or face-to-face contacts over 9 weeks. These were changed to remote sessions after 16 March 2020 due to the coronavirus disease 2019 pandemic.
UNASSIGNED: The primary outcome measure was the parent-reported Child Behaviour Checklist, which assesses the severity of behaviours that challenge.
UNASSIGNED: We found a small non-significant difference in the mean Child Behaviour Checklist scores (-4.23, 95% CI -9.98 to 1.52, p = 0.146) in the intervention arm compared to treatment as usual at 12 months. Per protocol and complier average causal effect sensitivity analyses, which took into consideration the number of sessions attended, showed the Child Behaviour Checklist mean score difference at 12 months was lower in the intervention arm by -10.77 (95% CI -19.12 to -2.42, p = 0.014) and -11.53 (95% CI -26.97 to 3.91, p = 0.143), respectively. The Child Behaviour Checklist mean score difference between participants who were recruited before and after the coronavirus disease 2019 pandemic was estimated as -7.12 (95% CI -13.44 to -0.81) and 7.61 (95% CI -5.43 to 20.64), respectively (p = 0.046), suggesting that any effect pre-pandemic may have reversed during the pandemic. There were no differences in all secondary measures. Stepping Stones Triple P is probably value for money to deliver (-£1057.88; 95% CI -£3218.6 to -£46.67), but decisions to roll this out as an alternative to existing parenting interventions or treatment as usual may be dependent on policymaker willingness to invest in early interventions to reduce behaviours that challenge. Parents reported the intervention boosted their confidence and skills, and the group format enabled them to learn from others and benefit from peer support. There were 20 serious adverse events reported during the study, but none were associated with the intervention.
UNASSIGNED: There were low attendance rates in the Stepping Stones Triple P arm, as well as the coronavirus disease 2019-related challenges with recruitment and delivery of the intervention.
UNASSIGNED: Level 4 Stepping Stones Triple P did not reduce early onset behaviours that challenge in very young children with moderate to severe intellectual disabilities. However, there was an effect on child behaviours for those who received a sufficient dose of the intervention. There is a high probability of Stepping Stones Triple P being at least cost neutral and therefore worth considering as an early therapeutic option given the long-term consequences of behaviours that challenge on people and their social networks.
UNASSIGNED: Further research should investigate the implementation of parenting groups for behaviours that challenge in this population, as well as the optimal mode of delivery to maximise engagement and subsequent outcomes.
UNASSIGNED: This study is registered as NCT03086876 (https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis±Angela&draw=1&rank=1).
UNASSIGNED: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: HTA 15/162/02) and is published in full in Health Technology Assessment; Vol. 28, No. 6. See the NIHR Funding and Awards website for further award information.
Research shows that in children without learning disabilities, parenting groups which support parents to develop skills to manage behaviours that challenge in their child can be helpful. The National Institute of Health and Care Excellence recommended that more research was needed to strengthen the evidence for such interventions for children with moderate to severe learning disability who are more likely to display behaviours that challenge in England. In this study, we tested in real-world conditions a programme called level 4 Stepping Stones Triple P, which has shown positive results in trials outside of the United Kingdom. Trained therapists delivered six groups and three individual sessions over 9 weeks to parents of children aged 30–59 months with moderate to severe learning disabilities. Two hundred and sixty-one parents were allocated to one of two arms by chance (randomisation): one received Stepping Stones Triple P and treatment as usual and the other treatment as usual only. Treatment as usual included support and advice by general practitioners or community child development teams. Our primary outcome was parent-reported child behaviour at 12 months after randomisation. We also collected data on other outcomes and carried out interviews with parents, service managers and therapists to find out their views about Stepping Stones Triple P. We did not find that Stepping Stones Triple P reduces behaviours that challenge in the child more than treatment as usual at 12 months. However, when we looked at people who received more than half of the sessions, there was a larger reduction in behaviours which suggests that Stepping Stones Triple P works for families if they attend the full programme. Stepping Stones Triple P seems to be good value for money, as we found that at 12 months (covering 10 months of costs), the Stepping Stones Triple P cost £1058 less than treatment as usual from a health and social care perspective. As such, Stepping Stones Triple P is fairly cheap to deliver and a suitable early intervention for behaviours that challenge especially because of positive feedback from parents. Throughout the trial, we included a Parent Advisory Group that oversaw study materials, interview topic guides and promotion of the study.