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Clinical Trials/NCT04385927
NCT04385927
Completed
N/A

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

IWK Health Centre1 site in 1 country66 target enrollmentJune 29, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Post Traumatic Stress Injury
Sponsor
IWK Health Centre
Enrollment
66
Locations
1
Primary Endpoint
Change in PTSI symptoms
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
June 29, 2020
End Date
December 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Patrick J. McGrath

Principal Investigator

IWK Health Centre

Eligibility Criteria

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-
  • 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

Outcomes

Primary Outcomes

Change in PTSI symptoms

Time Frame: 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

Secondary Outcomes

  • 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)

Study Sites (1)

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