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临床试验/NCT04556331
NCT04556331已完成不适用

Brief Online Group Parenting Programme for Anxious Parents of 1-3 Year Olds With the Aim of Reducing Transmission of Anxiety Through Generations: A Feasibility Study

King's College London1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2020年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
1
主要终点
Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)

研究概览

简要总结

To pilot a brief group early intervention aimed at reducing or preventing the intergenerational transmission of anxiety, with parents whose child is between 12 and 47 months. To explore feasibility and acceptability of such an intervention with this population.

详细描述

All participants will attend two group sessions of 'psychoeducation' (psychologically informed information about the topic of transmitting anxiety) and cognitive-behavioural strategies aimed at reducing the transmission of anxiety from parent to young child. The two sessions will be delivered online via Microsoft Teams, last 2 hours each and will run one week apart. Outcome and acceptability measures will be collected before, immediately after, and 6 weeks after the intervention. Feasibility data (e.g. drop-out rate) will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
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

  • •current or recent (within 2 years) primary diagnosis of anxiety disorder or self-report of clinically impairing anxiety problem within last 2 years,
  • •parent of child aged 12-47 months at time of intervention,
  • •access to an internet connection and smart phone/computer will be required to take part,
  • •male or female,
  • •resident in England,
  • •and over the age of 18

排除标准

  • •current severe co-morbid diagnoses, e.g. psychosis or acute suicidal risk (as the nature of the intervention is brief and in a group, the level of support needed to keep those with severe mental health disorders safe will not be available),
  • •current alcohol or drugs misuse

结局指标

主要结局

Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)

时间窗: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.

Validated measure of acceptability of an intervention - Acceptability of Intervention Measure (AIM) and Intervention Appropriateness Measure (IAM) (Weiner, Lewis et al. 2017)

Open text questions about participants' views on the acceptability

时间窗: Collected twice: immediately after intervention attendance (same day) and after 6 weeks.

Open text questions to gather qualitative information about participants' perspectives on usefulness, accessibility and unintended negative consequences

Actual attendance at each session as percentage of expected attendance

时间窗: Total across intervention period (up to 9 weeks, mid October 2020 to mid December 2020)

Percentage of count (people scheduled to attend each session / people who actually attended). To indicate feasibility of larger trial.

Number of participants who provided completed questionnaire measures

时间窗: Total across intervention and 6 week follow-up period (up to 15 weeks, mid October 2020 to January 2021)

Percentage of recruited participants who completed questionnaire measures at each of the three collection timepoints.

Number of participants who consented to take part as percentage of those who expressed initial interest.

时间窗: Total across recruitment period (up to 11 weeks, October 2020 to mid December 2020)

Percentage of count (people consent to take part / people expressing interest in response to advertising). To indicate feasibility of larger trial.

次要结局

  • Change in score on Depression Anxiety Stress Scale (Henry and Crawford 2005)(Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.)
  • Change in score on Brief Infant Toddler Social and Emotional Assessment (Briggs-Gowan, Carter et al. 2002)(Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.)
  • Bespoke questionnaire about self-reported use and confidence in behaviours specifically targeted in intervention.(Collected three times to access change: Before intervention, immediately after end of intervention (same day) and 6 weeks after.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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