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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05535348
Other study ID # 2022P000562
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 6, 2022
Est. completion date October 20, 2022

Study information

Verified date June 2023
Source Massachusetts General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Based on findings from our prior trials with parents of children with learning and attentional disabilities and parents of children with autism spectrum disorder (Kuhlthau et al., 2020; Park et al., 2020; IRB approved: #:2016P001622 and 2016P002037 respectively), the investigators propose to pilot test and refine the adapted resiliency intervention (SMART-3RP) among fathers of children with special health care needs.


Description:

This is an open pilot study. Based on Phase I findings (IRB #2021P002838), the investigators propose to enroll up to 12 fathers (in 2 groups) of children and youth with special health care needs (CYSHCN) in the adapted SMART-3RP intervention. The SMART-3RP is an 8-session mind-body resiliency intervention that will be conducted virtually. Participants will complete the study survey at baseline and immediately following the intervention. As this is a pilot, participants will also be asked to provide weekly feedback on program sessions and participate in an exit interview following the intervention. The intervention may be iteratively modified as the investigators receive feedback from participants.


Recruitment information / eligibility

Status Completed
Enrollment 14
Est. completion date October 20, 2022
Est. primary completion date September 29, 2022
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria: - Self-reported identify as father or male guardian of at least one child with special health care needs (e.g., autism spectrum disorder, cerebral palsy, dyslexia) - Age 18 or older - Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone and internet. Exclusion Criteria: - unable to speak or read English - unwilling or unable to participate in the study - considered medically or otherwise unable to participate by the study PI.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Relaxation Response Resiliency Program for Father of CYSHCN
Virtually delivered psycho-educational resiliency training program for fathers of CYSHCN

Locations

Country Name City State
United States Massachusetts General Hospital Boston Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kuhlthau KA, Luberto CM, Traeger L, Millstein RA, Perez GK, Lindly OJ, Chad-Friedman E, Proszynski J, Park ER. A Virtual Resiliency Intervention for Parents of Children with Autism: A Randomized Pilot Trial. J Autism Dev Disord. 2020 Jul;50(7):2513-2526. — View Citation

Luberto CM, Perez GK, Finkelstein-Fox L, Millstein RA, Fell L, Chad-Friedman E, Park ER, Kuhlthau KA. Acceptability of a Virtual Mind-Body Intervention for Parents of Children With Autism or Learning Disabilities. Glob Adv Health Med. 2021 Dec 9;10:216495 — View Citation

Park ER, Perez GK, Millstein RA, Luberto CM, Traeger L, Proszynski J, Chad-Friedman E, Kuhlthau KA. A Virtual Resiliency Intervention Promoting Resiliency for Parents of Children with Learning and Attentional Disabilities: A Randomized Pilot Trial. Matern — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Feedback regarding adapted intervention acceptability by session Likert ratings on post-session feedback surveys (0 to 5 with 5 more acceptable), qualitative responses from exit interviews 6 months
Secondary Feasibility (attendance at 6/8 sessions) Feasibility will be assessed using attendance (i.e. 6/8 sessions). 8 weeks
Secondary Feasibility (data collection number completing study surveys) Feasibility will be assessed using number of dads completing study surveys 3 months
Secondary Acceptability helpfulness ratings of sessions and aspects of program Acceptability will be assessed using a Participant Feedback questionnaire: questionnaire includes ratings of session helpfulness (1 to 5 with 1 being very helpful and 1 being not at all helpful), likert ratings of program aspects (number, length, etc of sessions), and open-ended qualitative feedback questions. 3 months
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