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NCT03578289
A Tele-mental Health Intervention to Support Parents Caring for a Technology-dependent Child at Home
NA trial testing Telemental Health - CBT in Mental Fatigue in 30 participants. Completed in 20 April 2019.
20 April 2019
Quick facts
| Lead sponsor | Boston Children's Hospital |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | crossover |
| Masking | none |
| Primary purpose | supportive care |
| Enrollment | 30 |
| Start date | 1 June 2017 |
| Primary completion | 20 April 2019 |
| Estimated completion | 20 April 2019 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Telemental Health - CBT
Conditions studied
- Mental Fatigue — all drugs for Mental Fatigue →
Sponsor
Boston Children's Hospital
Who can join
18 and older, any sex, with Mental Fatigue. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The need for assisted-technology at home reflects some of the most serious health-related conditions faced by children with physical and developmental disabilities. 'Technology-dependent' is often used in the literature to describe children "who need both a medical device to compensate for the loss of a vital body function and substantial and ongoing nursing care to avert death or further disability". Parenting a child is stressful and challenging, and even under ideal circumstances the care of a child with complex needs requires greater than normal parenting skills. Studies have showed that parents of children whose illness require assisted-technology experience significant emotional stress, potential gaps in social support, and social isolation leading to lower quality of life, unhealthy family functioning, and negative psychological consequences. This study intends to assess the feasibility and efficacy of a tele-psychotherapy (Tele-P) intervention as a way to promote the emotional functioning of parents and to help increase the quality of life of children that are technology-dependent in the Greater Boston Area. It is hypothesized that parents who adhere to psychotherapy sessions via videoconferencing (Tele-P) will demonstrate significant reductions in symptoms of depression, anxiety and social isolation. Children of parents in the (Tele-P) condition will show significantly greater improvements in their quality of life including their physical health, mental health, family life, free time, and general life enjoyment. A randomized controlled trial is proposed in order to evaluate the feasibility and efficacy of a tele-psychotherapy intervention for parents of technology-dependent children at the Critical Care, Anesthesia and Perioperative Extension (CAPE) program in Boston Children's Hospital. This study will serve as model for social workers to perform an intervention for parent's raising technology-dependent children. This study proposes that tele-psychotherapy be a means of advocating for this underserved population.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03578289
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
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- NCT05678374 — Exploring Immunological Markers Associated With Mental Fatigue in Graves' Disease · recruiting
Other Boston Children's Hospital trials
Trials by the same sponsor.
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- NCT06706336 — Radon Asthma Intervention Trial · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03578289 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Boston Children's Hospital
- Last refreshed: 22 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03578289.
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