Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children

Study Overview
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Brief Summary
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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.

Official Title
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Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children

Conditions
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Post Traumatic Stress Injury, Post Traumatic Stress Disorder

Intervention / Treatment
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* Behavioral: e-Net for Parents of Neurodiverse Children


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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-5. 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) Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Immediate e-NET Group<br>Parents of neurodiverse children with PTSI will receive e-NET immediately after the baseline survey | Behavioral: e-Net for Parents of Neurodiverse Children<br>* One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.<br>|
| Experimental: Wait List Control Group<br>Parents of neurodiverse children with PTSI will receive e-NET 3 months after the baseline survey | Behavioral: e-Net for Parents of Neurodiverse Children<br>* One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSI symptoms | 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 | Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Overall Health | General health will be measured with the questionnaire PROMIS Global Health Caregiver's general 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 Depression Symptoms | Depression symptoms will be measured with the Patient Health Questionnaire (PHQ-9) | Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up | 
| Change in overall functionality | Functionality will be measured with the Sheehan Disability Scale (SDS). SDS is measured on a 10-point scale (0-9). Higher score indicates a worse outcome. | Baseline; Wait list Baseline, Immediately Post intervention; 2 month follow up; 6 month follow up | 
| Posttraumatic Growth | Posttraumatic growth will be measures using the Posttraumatic Growth Inventory - Short Form (PTGI ). The PTGI is measured on a 6-point Likert scale (score 0-5). Higher score indicates a better outcome. | Baeline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up | 
| Parent-child Relationship | The parent-child relationship will be measured with the Parent and Family Adjustment Scales (PAFAS). Items are rated from 0 to 3. Note that shaded items in the scoring key below must be reverse scored (i.e. 0=3, 1=2, 2=1, 3=0) before summing the Total Score. High scores indicate worse outcome. | Baseline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up | 
| Satisfaction with Lifeline Tool | The satisfaction with Lifeline Tool (self-constructed) will be measured with a self-constructed 3-item usability questionnaire. It is scored on a five point scale. Items are rated from 0-4. Higher score indicates better outcome. | During week 1 of intervention | 
| Change in Anxiety Symptoms | Anxiety Symptoms are measured with the Generalized Anxiety Disorder (GAD-7). Items are scored on a four point scale, items are rated from 0-3. Higher score indicates better outcome. | Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up | 
| Change in Physical Health Symptoms | Physical Health symptoms will be assessed with the Patient Health Questionnaire Physical Symptoms (PHQ-15). Items are scored on a three point scale, items are rated from 0-2. Higher score indicates worse outcome. | Baseline; throughout study completion, approximately 12 week; Immediately Post-assessment; 2 month follow up; 6 month follow up | 
| Adverse Events | Adverse events will be assessed with a self-constructed questionnaire for adverse events, the course of symptoms during intervention and general distress. | throughout study completion, approximately 12 weeks; immediately post intervention | 
| Therapeutic Alliance | The interaction between coach and client will be assessed through the Therapeutic Alliance- Working Alliance Inventory - Short Form Revised (WAI-SR) | Immediately post intervention | 
| Participant Satisfaction | Client satisfaction will be assessed with the Client Satisfaction Questionnaire (CSQ-8) and some additional (self-constructed) qualitative questions. CAQ-8 Items are scored on a four point scale, items are rated from 0-3. Higher score indicates worse outcome. | Immediately Post intervention |