FAB：英国首次针对双相情感障碍青少年的家庭聚焦治疗未来随机对照试验的可行性试验。

FAB: First UK feasibility trial of a future randomised controlled trial of Family focused treatment for Adolescents with Bipolar disorder.

作者信息

Sharma A, Glod M, Forster T, McGovern R, McGurk K, Barron Millar E, Meyer T D, Miklowitz D, Ryan V, Vale L, Le Couteur A

机构信息

Newcastle University, Newcastle upon Tyne, UK.

Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust, Newcastle upon Tyne, UK.

出版信息

Int J Bipolar Disord. 2020 Aug 3;8(1):24. doi: 10.1186/s40345-020-00189-y.

DOI:10.1186/s40345-020-00189-y

PMID:32743735

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7396411/

Abstract

BACKGROUND

This first mixed-methods UK trial examined the feasibility and acceptability of a future definitive randomised controlled trial (RCT) to evaluate whether Family Focussed Treatment for Adolescents with Bipolar Disorder (FFT-A) UK version can improve family functioning and well-being as part of the management of Paediatric Bipolar Disorder (PBD).

METHOD

The trial used a randomised, parallel group, non-blinded design where participants received FFT-A UK (16 sessions over 6 months) immediately or after 12 months (delayed arm). Measures of family functioning, well-being and quality of life of the young person and the main carer (most commonly a parent) were completed at baseline, 6 and 12-months in both arms. Primary outcome measures included rates of eligibility, consent and retention along with estimates of variability in the measures and assessment of the intervention delivery. Qualitative interviews allowed assessment of participants' views about FFT-A and the trial processes.

RESULTS

Twenty-seven of 36 young persons with PBD and their families consented; of these, 14 families were randomised to the immediate and 13 to the delayed arm. Two families from the immediate arm withdrew consent and discontinued participation. Quantitative measures were completed by 22 families (88%) at 6-months and 21 families (84%) at 12-months. Qualitative interviews were conducted with 30 participants (9 young people, 15 parents and 6 other family members). Nine families attended 3 post-trial focus groups.

CONCLUSION

It was feasible to recruit and retain to this trial. The results highlighted that trial design and measures were acceptable to participants. A benefit in family relationships was reported by participants which they attributed to the intervention in qualitative interviews. Families recommended that future modifications include definitive trial(s) recruiting participants in the age range 15-25 years as it felt this was the age range with maximum need. Trial registration ISRCTN, ISRCTN59769322. Registered 20 January 2014, http://www.isrctn.com/ISRCTN59769322.

摘要

背景

这项英国首次采用混合方法的试验，检验了未来进行一项确定性随机对照试验（RCT）的可行性和可接受性，该试验旨在评估双相情感障碍青少年家庭聚焦治疗（FFT - A）英国版，作为儿童双相情感障碍（PBD）管理的一部分，是否能改善家庭功能和幸福感。

方法

该试验采用随机、平行组、非盲设计，参与者被立即分配接受FFT - A英国版治疗（6个月内进行16次治疗），或在12个月后接受治疗（延迟组）。在基线、6个月和12个月时，对青少年及其主要照顾者（最常见的是父母）的家庭功能、幸福感和生活质量进行测量。主要结局指标包括符合资格率、同意率和保留率，以及测量指标的变异性估计和干预实施评估。定性访谈用于评估参与者对FFT - A和试验过程的看法。

结果

36名患有PBD的青少年及其家庭中有27个同意参与；其中，14个家庭被随机分配到立即治疗组，13个家庭被分配到延迟治疗组。立即治疗组有2个家庭撤回同意并停止参与。22个家庭（88%）在6个月时完成了定量测量，21个家庭（84%）在12个月时完成了定量测量。对30名参与者（9名青少年、15名父母和6名其他家庭成员）进行了定性访谈。9个家庭参加了3次试验后焦点小组讨论。

结论

招募和留住参与者参与该试验是可行的。结果表明，试验设计和测量方法为参与者所接受。参与者在定性访谈中报告称，干预对家庭关系有益。家庭建议未来的改进包括进行确定性试验，招募年龄在15 - 25岁之间的参与者，因为他们认为这个年龄段的需求最大。试验注册编号：ISRCTN，ISRCTN59769322。于2014年1月20日注册，网址：http://www.isrctn.com/ISRCTN59769322 。