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研究方案:为 PTSD 患儿父母制定并开展预防混合照护养育干预的随机对照试验

Study protocol: development and randomized controlled trial of a preventive blended care parenting intervention for parents with PTSD.

机构信息

Sinai Centrum / Arkin Mental Health Care, Laan van de Helende Meesters 2, 1186 AM, Amstelveen, The Netherlands.

Department of Interdisciplinary Social Science, Utrecht University, Utrecht, The Netherlands.

出版信息

BMC Psychiatry. 2023 Feb 10;23(1):102. doi: 10.1186/s12888-023-04548-8.

Abstract

BACKGROUND

Children of parents with post-traumatic stress disorder (PTSD) are at increased risk of adverse psychological outcomes. An important risk mechanism is impaired parental functioning, including negative parenting behavior, perceived incompetence, and lack of social support. Several parenting interventions for trauma-exposed parents and parents with psychiatric disorders exist, but none have specifically targeted parents with PTSD. Our objective is to evaluate the effectiveness of a blended care preventive parenting intervention for parents with PTSD.

METHODS

The intervention was adapted from an existing online intervention, KopOpOuders Self-Help. In co-creation with parents with PTSD and partners, the intervention was adapted into KopOpOuders-PTSD, by adding PTSD-specific content and three in-person-sessions with a mental health prevention professional. Effectiveness will be tested in a randomized controlled trial among N = 142 parents being treated for PTSD at Arkin Mental Health Care (control condition: treatment as usual, n = 71; intervention condition: treatment as usual + intervention, n = 71). Online questionnaires at pretest, posttest, and three-month follow-up and ecological momentary assessment at pretest and posttest will be used. Intervention effects on primary (parenting behavior) and secondary outcomes (perceived parenting competence, parental social support, parenting stress, child overall psychological problems and PTSD symptoms) will be analyzed using generalized linear mixed modeling. We will also analyze possible moderation effects of parental PTSD symptoms at pretest on primary and secondary outcomes.

DISCUSSION

This study protocol describes the randomized controlled trial of KopOpOuders-PTSD, a blended care preventive parenting intervention for parents with PTSD. Findings can contribute to understanding of the effectiveness of parenting support in clinical practice for PTSD.

TRIAL REGISTRATION

This protocol (Version 1) was registered on 11-02-2022 at ClinicalTrials.gov under identification number NCT05237999.

摘要

背景

父母患有创伤后应激障碍(PTSD)的儿童患不良心理后果的风险增加。一个重要的风险机制是父母功能受损,包括负面育儿行为、感知能力不足和缺乏社会支持。有几种针对创伤暴露父母和精神障碍父母的育儿干预措施,但没有一种专门针对 PTSD 父母。我们的目标是评估针对 PTSD 父母的混合保健预防育儿干预的有效性。

方法

该干预措施是从现有的在线干预 KopOpOuders Self-Help 改编而来。与 PTSD 父母及其伴侣共同创作,干预措施通过添加特定于 PTSD 的内容和与心理健康预防专业人士进行三次面对面会议,改编为 KopOpOuders-PTSD。在 Arkin 心理健康护理(对照条件:常规治疗,n=71;干预条件:常规治疗+干预,n=71)中对 142 名正在接受 PTSD 治疗的父母进行了一项随机对照试验,以测试其有效性。使用在线问卷在预测试、后测试和三个月随访以及预测试和后测试的生态瞬时评估进行测试。使用广义线性混合模型分析干预对主要(育儿行为)和次要结果(感知育儿能力、父母社会支持、育儿压力、儿童整体心理问题和 PTSD 症状)的影响。我们还将分析父母 PTSD 症状在预测试对主要和次要结果的可能调节作用。

讨论

本研究方案描述了 KopOpOuders-PTSD 的随机对照试验,这是一种针对 PTSD 父母的混合保健预防育儿干预。研究结果可以帮助了解在临床实践中针对 PTSD 进行育儿支持的有效性。

试验注册

本方案(第 1 版)于 2022 年 2 月 11 日在 ClinicalTrials.gov 上注册,识别号为 NCT05237999。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/6af9/9921412/abf824c6c0ca/12888_2023_4548_Fig1_HTML.jpg

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