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

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05535348
• Other study ID #: 2022P000562
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Family
• Fathers
• Stress

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