Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs

Not Applicable

Completed

• Conditions: Stress; Family; Fathers
• Interventions: Behavioral: Relaxation Response Resiliency Program for Father of CYSHCN

• Registration Number: NCT05535348
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2022-05-06
• Study First Submitted: 2022-06-25
• Study First Submitted QC: 2022-09-06
• Study First Posted: 2022-09-10
• Primary Completion: 2022-09-29
• Study Completion: 2022-10-20
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 14

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open Pilot	Relaxation Response Resiliency Program for Father of CYSHCN	An adapted version of the Relaxation Response Resiliency Program (3RP) for fathers of CYSHCN. The adapted program incorporates the three prongs of the 3RP: RR elicitation, stress awareness, and adaptive strategies.

Primary Outcome Measures

Name	Time	Method
Feedback regarding adapted intervention acceptability by session	6 months	Likert ratings on post-session feedback surveys (0 to 5 with 5 more acceptable), qualitative responses from exit interviews

Secondary Outcome Measures

Name	Time	Method
Feasibility (data collection number completing study surveys)	3 months	Feasibility will be assessed using number of dads completing study surveys
Feasibility (attendance at 6/8 sessions)	8 weeks	Feasibility will be assessed using attendance (i.e. 6/8 sessions).
Acceptability helpfulness ratings of sessions and aspects of program	3 months	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.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States