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

Post Traumatic Stress Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04385927
• Other study ID #: 23865
• Status: Completed
• Phase: N/A
• Start date: June 29, 2020
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2022
• Source: IWK Health Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: December 31, 2021
• Est. primary completion date: August 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Post Traumatic Stress Disorder
• Post Traumatic Stress Injury
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• e-Net for Parents of Neurodiverse Children
One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.

Locations

Country	Name	City	State
Canada	IWK Health Centre	Halifax	Nova Scotia

Sponsors (3)

Lead Sponsor	Collaborator
IWK Health Centre	Canadian Institutes of Health Research (CIHR), Child-Bright Network

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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