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

NCT04385927 | Completed

• 1 other identifier: 23865
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Injury; Post Traumatic Stress Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (11)

• 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 Depression Symptoms

  Baseline, 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

• Posttraumatic Growth

  Baeline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up

• Parent-child Relationship

  Baseline; Wait list Baseline; Immediately Post intervention; 2 month follow up; 6 month follow up

Study Arms (2)

Immediate e-NET Group

EXPERIMENTAL

Parents of neurodiverse children with PTSI will receive e-NET immediately after the baseline survey

Behavioral: e-Net for Parents of Neurodiverse Children

Wait List Control Group

EXPERIMENTAL

Parents of neurodiverse children with PTSI will receive e-NET 3 months after the baseline survey

Behavioral: e-Net for Parents of Neurodiverse Children

Interventions

e-Net for Parents of Neurodiverse Children BEHAVIORAL

One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.

Immediate e-NET Group; Wait List Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• IWK Health Centre: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• Child-Bright Network: collaborator

Study Sites (1)

IWK Health Centre

Halifax, Nova Scotia, B3K6R8, Canada

Location

Related Publications (2)

• Jones KA, Freijah I, Brennan SE, McKenzie JE, Bright TM, Fiolet R, Kamitsis I, Reid C, Davis E, Andrews S, Muzik M, Segal L, Herrman H, Chamberlain C. Interventions from pregnancy to two years after birth for parents experiencing complex post-traumatic stress disorder and/or with childhood experience of maltreatment. Cochrane Database Syst Rev. 2023 May 4;5(5):CD014874. doi: 10.1002/14651858.CD014874.pub2.

  PMID: 37146219 DERIVED

• 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.

  PMID: 34868484 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Patrick McGrath, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

• Elisa Kaltenbach, PhD

  IWK Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2020
• First Posted: May 13, 2020
• Study Start: June 29, 2020
• Primary Completion: August 31, 2021
• Study Completion: December 31, 2021
• Last Updated: March 31, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)