Clinical trial NCT04385927: Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children
Official title: Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Traumatic Stress Injury
Post Traumatic Stress Disorder
Lead sponsor: IWK Health Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Child-Bright Network
First posted: 2020-05-13
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria: Parent/Caregivers must meet the following criteria to be eligible to move on to Consent

1. Be a parent/caregiver of a neurodiverse child
2. Be at least 18 years of age
3. Be able to understand spoken and written English at a Grade 8 level
4. 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.
5. Have access to a computer with high speed Internet
6. Live in Canada
7. Commit to the requirements of taking part in the study (12 weekly coaching calls)

Exclusion Criteria:

1. Acute suicidal behavior or other extreme forms of self-destructive behavior
2. Moderate to severe symptoms of dissociation
3. Acute psychotic symptoms
4. Previously participated in exposure intervention for PTSI/PTSD

Primary outcomes:
measure: Change in PTSI symptoms
timeFrame: Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention
Secondary outcomes:
measure: Change in Overall Health
timeFrame: Baseline, Wait-list Baseline; through study completion, an average of 12 weeks; Immediately Post-assessment; 2 month follow up; 6 month follow up
measure: Change in Depression Symptoms
timeFrame: Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up
measure: Change in overall functionality
timeFrame: Baseline; Wait list Baseline, Immediately Post intervention; 2 month follow up; 6 month follow up
measure: Posttraumatic Growth
timeFrame: Baeline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up
measure: Parent-child Relationship
timeFrame: Baseline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up
measure: Satisfaction with Lifeline Tool
timeFrame: During week 1 of intervention
measure: Change in Anxiety Symptoms
timeFrame: Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up
measure: Change in Physical Health Symptoms
timeFrame: Baseline; throughout study completion, approximately 12 week; Immediately Post-assessment; 2 month follow up; 6 month follow up
measure: Adverse Events
timeFrame: throughout study completion, approximately 12 weeks; immediately post intervention
measure: Therapeutic Alliance
timeFrame: Immediately post intervention
measure: Participant Satisfaction
timeFrame: Immediately Post intervention
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: IWK Health Centre
state: Nova Scotia
Study officials:
affiliation: IWK Health Centre
name: Patrick McGrath, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: IWK Health Centre
name: Elisa Kaltenbach, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaltenbach E, Chisholm M, Xiong T, Thomson D, Crombach A, McGrath PJ. Online narrative exposure therapy for parents of children with neurodevelopmental disabilities suffering from posttraumatic stress symptoms - study protocol of a randomized controlled trial. Eur J Psychotraumatol. 2021 Nov 21;12(1):1991650. doi: 10.1080/20008198.2021.1991650. eCollection 2021.