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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Stress, Family, Fathers

Intervention / Treatment
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* Behavioral: Relaxation Response Resiliency Program for Father of CYSHCN


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: We ran two groups of a resiliency intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Pilot<br>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. | Behavioral: Relaxation Response Resiliency Program for Father of CYSHCN<br>* Virtually delivered psycho-educational resiliency training program for fathers of CYSHCN<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility (attendance at 6/8 sessions) | Feasibility will be assessed using attendance (i.e. 6/8 sessions). | 8 weeks | 
| Feasibility (data collection number completing study surveys) | Feasibility will be assessed using number of dads completing study surveys | 3 months | 
| 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 |