A Tele-mental Health Intervention to Support Parents Caring for a Technology-dependent Child at Home

NCT03578289 | Completed

• 1 other identifier: IRB-P00023319
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Mental Fatigue

Keywords

Parents of children with disabilities; emotional functioning

Outcome Measures

Primary Outcomes (1)

• Number of participants in the intervention

  Number of participants who complete the intervention

  12 Months

Secondary Outcomes (1)

• Patient-Reported Outcomes Measurement Information Systems (PROMIS) Global Scale

  12 Months

Study Arms (2)

Experimental Group (telemental health_

EXPERIMENTAL

The experimental group will received cognitive behavioral therapy (CBT) via TMH for 8 sessions.

Behavioral: Telemental Health - CBT

Waiting Control Group (usual care)

EXPERIMENTAL

Participants randomly assigned to the control group will receive routine care for three months followed by the 8-week CBT intervention

Behavioral: Telemental Health - CBT

Interventions

Telemental Health - CBT BEHAVIORAL

The experimental group will received cognitive behavioral therapy (CBT) via TMH for 8 sessions.

Experimental Group (telemental health_; Waiting Control Group (usual care)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Parent of child cared for in the CAPE Program
• years of age or older
• Lack of active mental health counseling
• English or Spanish speaking

You may not qualify if:

• History of psychosis in the past six months
• Receipt of any mental health treatment within the 3 months prior to study enrollment
• Future appointment with a mental health provider within the next two months and evidence of suicidal thoughts

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Childrens Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Mental Fatigue

Condition Hierarchy (Ancestors)

Fatigue; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Social Worker

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: July 6, 2018
• Study Start: June 1, 2017
• Primary Completion: April 20, 2019
• Study Completion: April 20, 2019
• Last Updated: November 22, 2019

Record last verified: 2019-11

Locations

US (1)