NCT04385927

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

Completed NA Last updated 31 March 2022

What this trial tests

NA trial testing e-Net for Parents of Neurodiverse Children in Post Traumatic Stress Injury in 66 participants. Completed in 31 December 2021.

Timeline

29 June 2020

Primary endpoint
31 August 2021

31 December 2021

Quick facts

Lead sponsor	IWK Health Centre
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	66
Start date	29 June 2020
Primary completion	31 August 2021
Estimated completion	31 December 2021
Sites	1 location across Canada

Drugs / interventions tested

• e-Net for Parents of Neurodiverse Children

Conditions studied

• Post Traumatic Stress Injury — all drugs for Post Traumatic Stress Injury →
• Post Traumatic Stress Disorder — all drugs for Post Traumatic Stress Disorder →

Sponsor

IWK Health Centre — full company profile →

Who can join

18 and older, any sex, with Post Traumatic Stress Injury or Post Traumatic Stress Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Online narrative exposure therapy for parents of children with neurodevelopmental disabilities suffering from posttraumatic stress symptoms - study protocol of a randomized controlled trial.
   Kaltenbach E, Chisholm M, Xiong T, Thomson D, et al · · 2021 · cited 3× · PMID 34868484 · DOI 10.1080/20008198.2021.1991650