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Completed

NCT Number: NCT04385927

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

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.

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Key information

Conditions

Post Traumatic Stress Injury Mental Disorders Post Traumatic Stress Disorder Stress Disorders, Post-Traumatic Stress Disorders, Traumatic Trauma and Stressor Related Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IWK Health Centre

Halifax, Nova Scotia, B3K6R8, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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-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)

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

Treatment and study plan

e-Net for Parents of Neurodiverse Children

Behavioral

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

Primary outcomes

  1. 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

  1. Change in Overall Health

    Time frame: Baseline, Wait-list Baseline; through study completion, an average of 12 weeks; Immediately Post-assessment; 2 month follow up; 6 month follow up

    General health will be measured with the questionnaire PROMIS Global Health Caregiver's general health

  2. Change in Depression Symptoms

    Time frame: Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up

    Depression symptoms will be measured with the Patient Health Questionnaire (PHQ-9)

  3. Change in overall functionality

    Time frame: Baseline; Wait list Baseline, Immediately Post intervention; 2 month follow up; 6 month follow up

    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.

  4. Posttraumatic Growth

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

    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.

  5. Parent-child Relationship

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

    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.

  6. Satisfaction with Lifeline Tool

    Time frame: During week 1 of intervention

    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.

  7. Change in Anxiety Symptoms

    Time frame: Baseline, Immediately Post-assessment, 2 month follow up, 6 month follow up

    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.

  8. Change in Physical Health Symptoms

    Time frame: Baseline; throughout study completion, approximately 12 week; Immediately Post-assessment; 2 month follow up; 6 month follow up

    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.

  9. Adverse Events

    Time frame: throughout study completion, approximately 12 weeks; immediately post intervention

    Adverse events will be assessed with a self-constructed questionnaire for adverse events, the course of symptoms during intervention and general distress.

  10. Therapeutic Alliance

    Time frame: Immediately post intervention

    The interaction between coach and client will be assessed through the Therapeutic Alliance- Working Alliance Inventory - Short Form Revised (WAI-SR)

  11. Participant Satisfaction

    Time frame: Immediately Post intervention

    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.

Sponsors and collaborators

Lead sponsor

IWK Health Centre

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Child-Bright Network

Registry information

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 13, 2020
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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