跳至主要内容
临床试验/NCT03916172
NCT03916172Unknown不适用

Randomised Evaluation of Brief Psychological Intervention for Parents of Adolescents: The Open Door Approach to Parenting Teenagers (APT), in London, England

Open Door Young People's Service2 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年12月12日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
2
主要终点
Stress Index for Parents of Adolescents (SIPA)

研究概览

简要总结

Adolescence is a challenging period for young people and their parents. Changes during adolescence bring increases in social, psychological and behavioural problems (such as gang membership and drug abuse), and most long-lasting mental health problems start during this period. One of the strongest predictors of adolescent outcomes is the quality of parenting they receive at this stage. Parents often struggle with parenting adolescents, leading to feelings of stress and incompetence which, when reaching clinical levels, result in physical and mental health difficulties for parents and their children. This puts significant strain on community, social and mental health services. While the effectiveness of programmes to support parents of adolescents is certain, most are group-based and struggle to retain participants, especially amongst those who need help most: clinically stressed, and single parents. There are no standard care pathways for these parents, which leads to chronic problems and high long-term cost. The present study aims to measure the effectiveness of the Open Door's Approach to Parenting Teenagers (APT) - a manualised, six-session individual parenting intervention focusing on the relationship between parent and adolescent. This brief intervention, developed with awareness of the organisational realities and overarching aims of the National Health Service (NHS), has shown good results amongst clinically stressed parents in a pilot trial. The next phase in evaluating this approach is ruling out spontaneous recovery, by randomly assigning participants to APT or a waiting list control and comparing their results after the intervention, and again after 3 months. If successful, this study will have a major impact on communities around the United Kingdom (UK) - offering an evidence-based, non-proprietary intervention that can be easily disseminated.

详细描述

This study is the next step in the evaluation trajectory of the Open Door Approach to Parenting Teenagers (APT), and is a randomised controlled trial investigating whether receiving APT is more effective than being on a Waiting List (WL) in a sample of 60 parents of adolescents. We hypothesise that in comparison to those on the WL, those receiving APT will show significant improvements in:

  • parental stress;
  • parent-adolescent relationship;
  • adolescent and parent wellbeing and mental health outcomes;

Secondary aims of the study will include:

  • Ascertaining treatment fidelity
  • Disseminating outcomes to inform policymakers, commissioners and providers, to facilitate evidence-based decisions about community services.

Procedure This trial will be carried out at two clinical sites in North London over 12months.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Being a parent of an adolescent aged 11-18 years
  • Adolescent currently lives with parent for a minimum of 2 days/week
  • Parent demonstrates clinically significant levels of concern on primary measure (Stress Index for Parents of Adolescents)
  • Parent must be proficient in English so they may fully understand the material presented to them during the research study

排除标准

  • Parent currently receiving treatment for psychotic illness
  • Parent previously received APT intervention
  • Adolescent has severe developmental disorder (e.g. Autism Spectrum Disorder) or serious life threatening health impairment
  • Adolescent currently receiving individual psychotherapeutic treatment

研究组 & 干预措施

APT Treatment

Experimental

Participants in this arm will receive the Open Door Approach to Parenting Teenagers (APT). It offers 6 weekly 50-minute appointments with an optional 7th review session.

干预措施: The Open Door Approach to Parenting Teenagers (APT) (Behavioral)

Waiting List

No Intervention

Participants in this group will be placed on a waiting list and will receive APT treatment after no longer than 25 weeks.

结局指标

主要结局

Stress Index for Parents of Adolescents (SIPA)

时间窗: 5 months

This is a 112-item, self report that is structured into three main domain scores: Adolescent Domain (AD), Parent Domain (PD), and Adolescent-Parent Relationship Domain (APRD). The AD has 4 subscale scores: Moodiness/Emotional Lability (MEL), Social Isolation/Withdrawal (ISO), Delinquency/Antisocial (DEL), and Failure to Achieve or Persevere (ACH). The PD also has 4 subscale: Life Restrictions (LFR), Relationship with Spouse/Partner (REL), Social Alienation (SOC) and Incompetence/Guilt (INC). The APRD has no subscales. The Index of Total Parenting Stress (TPS) is a composite score computed from all items. Scores are then classified into broad ranges: normal, borderline, clinically significant and clinically severe.

次要结局

  • Alabama Parenting Questionnaire - Short Form (APQ-SF)(5 months)
  • Alabama Parenting Questionnaire Young Person version (APQ-YP)(5 months)
  • Strengths And Difficulties Questionnaire Parent Version (SDQ-P)(5 months)
  • Generalised Anxiety Disorder Screener (GAD-7)(5 months)
  • Patient Health Questionnaire Module 9 (PHQ-9)(5 months)
  • Parenting Scale (PS)(5 months)
  • Strengths and Difficulties Questionnaire Young Person Version (SDQ-YP)(5 Months)
  • Reflective Function Questionnaire (RFQ)(5 months)
  • EQ-5D-5L(5 months)
  • Conflict Behaviour Questionnaire (CBQ)(5 months)
  • Goal Based Measure(5 months)
  • Working Alliance Inventory-Short Form-Client (WAI-SF-C)(5 months)
  • Working Alliance Inventory-Observer (WAI-O)(5 months)
  • Experience of Services Questionnaire(5 months)
  • Working Alliance Inventory-Short Form-Therapist (WAI-SF-T)(5 months)
  • Adherence to the APT Model(5 months)

研究者

发起方
Open Door Young People's Service
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alex Desiatnikov

Dr. Alex Desiatnikov

Open Door Young People's Service

研究点 (2)

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