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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04385927
Recruitment Status : Completed
First Posted : May 13, 2020
Last Update Posted : March 31, 2022
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Child-Bright Network
Information provided by (Responsible Party):
Patrick J. McGrath, IWK Health Centre

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.


Condition or disease Intervention/treatment Phase
Post Traumatic Stress Injury Post Traumatic Stress Disorder Behavioral: e-Net for Parents of Neurodiverse Children Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Life Beyond Trauma: 1-on-1 e-Health Program for Parents of Neurodiverse Children
Actual Study Start Date : June 29, 2020
Actual Primary Completion Date : August 31, 2021
Actual Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Immediate e-NET Group
Parents of neurodiverse children with PTSI will receive e-NET immediately after the baseline survey
Behavioral: e-Net for Parents of Neurodiverse Children
One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.

Experimental: Wait List Control Group
Parents of neurodiverse children with PTSI will receive e-NET 3 months after the baseline survey
Behavioral: e-Net for Parents of Neurodiverse Children
One-on-one distance coached intervention; approx. 12 sessions at 60-90 minutes.




Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04385927


Locations
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Canada, Nova Scotia
IWK Health Centre
Halifax, Nova Scotia, Canada, B3K6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Child-Bright Network
Investigators
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Principal Investigator: Patrick McGrath, PhD IWK Health Centre
Principal Investigator: Elisa Kaltenbach, PhD IWK Health Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Patrick J. McGrath, Principal Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT04385927    
Other Study ID Numbers: 23865
First Posted: May 13, 2020    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders