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Post Traumatic Stress InjuryNCT04385927

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

A study testing e-Net for Parents of Neurodiverse Children in people with Post Traumatic Stress Injury and Post Traumatic Stress Disorder, run by IWK Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
e-Net for Parents of Neurodiverse Children
Could I receive a placebo?
No, everyone receives an active treatment
How many people
66 participants
Where
1 siteCanada
Study dates
29 Jun 2020to 31 Dec 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

None listed.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health Centre

    Halifax, Nova Scotia, B3K6R8

Other trials in Canada

About this study

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.

Being tested
e-Net for Parents of Neurodiverse Children
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • e-Net for Parents of Neurodiverse ChildrenBehavioural

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

Study groups in NCT04385927
Study groupRoleWhat they receive
Immediate e-NET GroupExperimentalParents of neurodiverse children with PTSI will receive e-NET immediately after the baseline survey
Receives: Behavioral: e-Net for Parents of Neurodiverse Children
Wait List Control GroupExperimentalParents of neurodiverse children with PTSI will receive e-NET 3 months after the baseline survey
Receives: Behavioral: e-Net for Parents of Neurodiverse Children

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention

Secondary outcomes (11)

  1. Change in Overall Health

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

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

  2. Change in Depression Symptoms

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

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

  6. 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.

    Measured: During week 1 of intervention

  7. 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.

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

  8. 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.

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

  9. Adverse Events

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

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

  10. Therapeutic Alliance

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

    Measured: Immediately post intervention

  11. 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.

    Measured: Immediately Post intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 May 2020
  2. Study start29 Jun 2020
  3. Primary completion31 Aug 2021
  4. Study completion31 Dec 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04385927
Sponsor's protocol ID
23865
Status last verified
Mar 2022
First submitted
23 Mar 2020
Last updated
31 Mar 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37146219

  • 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.

    PubMed 34868484

Questions about this trial

What is this clinical trial studying?

A study testing e-Net for Parents of Neurodiverse Children in people with Post Traumatic Stress Injury and Post Traumatic Stress Disorder, run by IWK Health Centre at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in PTSI symptoms (time frame: Baseline, Immediately Post- intervention, 2 months post-intervention, 6 months post-intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04385927, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.

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