Clinical trial NCT05535348: Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs
Official title: Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Family
Fathers
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 14
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: We ran two groups of a resiliency intervention.
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feedback regarding adapted intervention acceptability by session
timeFrame: 6 months
Secondary outcomes:
measure: Feasibility (attendance at 6/8 sessions)
timeFrame: 8 weeks
measure: Feasibility (data collection number completing study surveys)
timeFrame: 3 months
measure: Acceptability helpfulness ratings of sessions and aspects of program
timeFrame: 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Karen A Kuhlthau, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1007/s10803-019-03976-4.
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;10:21649561211047804. doi: 10.1177/21649561211047804. eCollection 2021.
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 Child Health J. 2020 Jan;24(1):39-53. doi: 10.1007/s10995-019-02815-3.