Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Change in PTSI symptoms
研究概览
简要总结
Parents of neurodiverse children are more likely to experience traumatic events related to the care of their child/children. This increases the probability to experience Posttraumatic Stress Injury (PTSI). However, interventions addressing PTSI symptoms in parents are rare.
In this research project the study investigators will test the feasibility and efficacy of e-NET, a distance-delivered, exposure-based intervention for PTSI adapted to the needs of parents of neurodiverse children. E-NET is an adapted version of the Narrative Exposure Therapy (NET), an evidence-based intervention approach for individuals with PTSI who have experienced repeated or continuous trauma. The intervention will be conducted via videoconferencing with trained paraprofessionals. During the intervention a narrative of both positive and negative (traumatic) experiences in the parents' life will be created. The intervention contains approx. 12 one-on-one sessions with a trained paraprofessional via videoconferencing.
The study design is a waitlist control group design. Approx. 20 participants will receive e-NET directly after the baseline survey and 20 participants will receive e-NET approx. 3 months after the baseline survey. To test the efficacy of the intervention, participants will fill out surveys about PTSI and other mental health symptoms before, directly after, and 2 and 6 months after the intervention. Adverse events and distress will be assessed in every session. As part of the baseline, participants will complete the survey "Surviving and Thriving in Parenting Neurodiverse Children" to determine their eligibility for the intervention. Main eligibility criterion is the presence of PTSI symptoms.
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
- 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
- 否
入选标准
- •Parent/Caregivers must meet the following criteria to be eligible to move on to Consent
- •Be a parent/caregiver of a neurodiverse child
- •Be at least 18 years of age
- •Be able to understand spoken and written English at a Grade 8 level
- •Fulfill the criteria of full or subclinical PTSI according to DSM-5, measured with the Life Events Checklist for DSM-5, the Parent Trauma Checklist and the PTSD Checklist for DSM-
- •For this they have to report at least one traumatic event in the LEC-5 or the Stressful Life Experiences of Parents Checklist. To fulfill all PTSI criteria, the participant additionally needs to respond with "moderately" or higher in at least one item for the criteria B and C and two items for criteria D and E. Subclinical PTSI is fulfilled if the participant meets all but one criterion of B, C, D, or E is not met.
- •Have access to a computer with high speed Internet
- •Live in Canada
- •Commit to the requirements of taking part in the study (12 weekly coaching calls)
排除标准
- •Acute suicidal behavior or other extreme forms of self-destructive behavior
- •Moderate to severe symptoms of dissociation
- •Acute psychotic symptoms
- •Previously participated in exposure intervention for PTSI/PTSD
结局指标
主要结局
Change in PTSI symptoms
时间窗: Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention
PTSD symptoms are measured with the PTSD Checklist - 5 (PCL-5). Respondents are asked to rate how bothered they have been by each of 20 items in the past month on a 5- point Likert scale ranging from 0-4. Items are summed to provide a total severity score. Higher scores indicate a worse outcome
次要结局
- Posttraumatic Growth(Baeline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up)
- Adverse Events(throughout study completion, approximately 12 weeks; immediately post intervention)
- Change in Overall Health(Baseline, Wait-list Baseline; through study completion, an average of 12 weeks; Immediately Post-assessment; 2 month follow up; 6 month follow up)
- Change in overall functionality(Baseline; Wait list Baseline, Immediately Post intervention; 2 month follow up; 6 month follow up)
- Change in Depression Symptoms(Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up)
- Satisfaction with Lifeline Tool(During week 1 of intervention)
- Change in Anxiety Symptoms(Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up)
- Change in Physical Health Symptoms(Baseline; throughout study completion, approximately 12 week; Immediately Post-assessment; 2 month follow up; 6 month follow up)
- Therapeutic Alliance(Immediately post intervention)
- Parent-child Relationship(Baseline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up)
- Participant Satisfaction(Immediately Post intervention)
研究者
Patrick J. McGrath
Principal Investigator
IWK Health Centre