跳至主要内容
临床试验/NCT02030730
NCT02030730已完成不适用

A Randomised Controlled Trial of the Efficacy of Triple P (Positive Parenting Program) Seminar Series as a Universal Parenting Intervention for the Prevention of Emotional and Behavioural Difficulties in Greek Children Aged 2 to 12.

University of Oxford2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2012年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
124
试验地点
2
主要终点
Eyberg Child Behaviour Inventory- Intensity scale (ECBI; Eyberg & Pincus, 1999)

研究概览

简要总结

This study investigates the impact of a Triple P Seminar Series on positive parenting for universal prevention of behavioural and emotional difficulties in a general Greek sample of parents with children aged 2 to 12. It is predicted that, compared to an attention control condition, parents randomised to the Seminar Series will report lower levels of children's disruptive and emotional difficulties at post-intervention. At the same time, it is postulated that parents will show a decrease in dysfunctional discipline styles, greater feelings of self-efficacy as well as lower levels of distress. Lastly, it is hypothesized that the effects observed at post-intervention will remain at the 6-month follow-up.

详细描述

Phase 1: Recruitment Child and family organisations will invite the general public by advertising the study through the organisations' member lists, contacts with schools and other health institutions, social networks, and mass media. Parents who have at least a child between 2 to 12 years old, living in the general area of Attica and being available to attend three Seminars (once per month) will be eligible. The researcher will receive from the organisations the list of all parents who contacted them and were interested in taking part in the study; the list will then be shared with his assistant. The assistant will sign a subcontract. All parents will receive an envelope which includes: (1) a thank you letter; (2) participant information sheet and two informed consents; (3) the pre-assessment baseline booklet including background information, parenting and child measures; (4) a pre-paid envelope so they could easily return them.

Written-informed consent: Eligible adult participants will provide informed consent. The adult informed consent process involves presenting a detailed written description of the study as it is described on the printed information and consent forms. Participants will be informed of the procedures for ensuring their protection, including:

  1. participation is voluntary and free of charge;
  2. participants will be informed that they will have an equal chance to get the Seminar Series through a fair process;
  3. participants will be informed that their personal contact details will be shared with the researcher and his assistant;
  4. the questionnaires which will be distributed are not anonymous. This is because all questionnaires will be distributed by mail;
  5. the confidentiality of participants' personal data will be guaranteed though specific procedures to protect their anonymity: (a) all information provided will remain strictly confidential; (b) participants' names and other identifiers will not be written on any transcriptions or other research data; (c) unique non-personally identifying ID numbers instead of names on research materials will be used. This code will be placed on the survey and other collected data. Through an identification key, the researcher's assistant will be able to link records to participants' identity; and (d) data will maintained in locked computer databases, and participants study files, video and audio tapes of the Seminars in locked filing cabinets in locked rooms; (e) only the researcher, his assistant and the researcher's supervisor will have access to the data; (f) at the end of the project all information, including the video and audio tapes of the first 3 Seminars will be in locked cabinets at the researcher's office and all databases, audio and video files will be stored to his computer for future academic research and/or training of other health professionals; a password will be required for access to the databases. After focus group transcription the video and audio tapes of focus groups will be destroyed by the researcher;
  6. participants will be informed that the Seminar Series will be audio and video recorded and the tapes will only be used for academic and training reasons. At Seminar 1, 2, 3 the cameras will be set at the back of the room, behind the participants so that their face will not be recorded. For focus groups video will only be used if the sound of the audio recorder is unclear to distinguish what it is said, as parents may speak simultaneously or soft. After focus group transcription the video and audio tapes will be destroyed by the researcher.
  7. participants can refuse to participate in either the intervention or research and/or can discontinue participation without penalty at any time by advising the researchers of this decision. By withdrawing from the study, they also have the right to withdraw all their data collected until that point.
  8. in case of further questions participants can directly ask the researcher by phone or email who will do his best to answer their query. If they remain unhappy and wish to make a formal complaint, they can contact the Research Ethics Committee at the University of Oxford (ethics@socsci.ox.ac.uk; +44 (0)1865 614871; Social Sciences & Humanities Inter-Divisional Research Ethics Committee, Oxford University, Hayes House, 75 George Street, Oxford, OX1 2BQ, UK).

For parents who request additional professional help, a list with psychological health services will be provided. Participants may participate only after having read the information sheet and had signed it. All consenting and assenting participants will be offered a copy of the informed consent form. Parents who do not respond to their invitation for the Seminars will be asked to give phone-consent.

Regarding the consent form, the information sheet and the rest of the questionnaires which were in English, first they were translated by the researcher into Greek. All translations were reviewed by two Greek parents and a Greek Lecturer in Linguistics at University of Cambridge for understanding and relevance of the translated terms. All translations were adjusted according to the reviewers' comments. At the end, a Greek-American Health Professional checked if the final Greek translations matched the original English ones. The Conners and the SQD have officially been translated in Greek.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • In this study participants are parents who:
  • have at least one child aged between 2-12 years old
  • live in the general area of Attica
  • have returned a signed informed consent
  • have completed baseline measures

排除标准

  • 未提供

研究组 & 干预措施

Triple P Seminar Series

Experimental

Intervention parents received the Seminar Series (Selected TripleP); three 90-minute seminars ('The Power of Positive Parenting', 'Raising Confident, Competent Children', and 'Raising Resilient Children'), including 60 minutes of scripted presentation material and 30 minutes question time for discussion. Parents received tip sheets with the material presented at the end of each seminar. The seminars were free of charge. The delivery of each seminar was 2 to 4 weeks apart.

干预措施: Triple P Seminar Series (Behavioral)

Leaflets on child health and development

No Intervention

An attention control group received leaflet information on child health and development provided by the Greek National Health Services of the Ministry of Health. They cover topics such as vaccinations, common childhood illnesses, first aid guide on severe injuries and cuts, and nutrition. The topics did not overlap with the topics of the Seminar Series or the general purpose of the study. Control families received the seminar tip sheets after 6-month follow-up.

结局指标

主要结局

Eyberg Child Behaviour Inventory- Intensity scale (ECBI; Eyberg & Pincus, 1999)

时间窗: April 2012, July-September 2012, March 2013

It was used to investigate the intensity of behavioural difficulties.

次要结局

  • Eyberg Child Behaviour Inventory- Problem scale (ECBI; Eyberg & Pincus, 1999)(April 2012, July-September 2012, March 2013)
  • The Conners Parent Rating Scale (CPRS; Goyette, Conners, & Ulrich, 1978)(April 2012, July-September 2012, March 2013)
  • Parenting Tasks Checklist (PTC; Sanders & Wooley, 2005)(April 2012, July-September 2012, March 2013)
  • Parenting Scale (PS; Arnold, O'Leary, Wolff, & Acker, 1993)(April 2012, July-September 2012, March 2013)
  • General Health Questionnaire (GHQ; Goldberg & Williams, 1988)(April 2012, July-September 2012, March 2013)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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