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

NCT05535348 | Completed

• 1 other identifier: 2022P000562
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress; Family; Fathers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Feasibility (attendance at 6/8 sessions)

  8 weeks

• Feasibility (data collection number completing study surveys)

  3 months

• Acceptability helpfulness ratings of sessions and aspects of program

  3 months

Study Arms (1)

Open Pilot

EXPERIMENTAL

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

Interventions

Relaxation Response Resiliency Program for Father of CYSHCN BEHAVIORAL

Virtually delivered psycho-educational resiliency training program for fathers of CYSHCN

Open Pilot

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: 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)
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Related 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. doi: 10.1007/s10803-019-03976-4.

  PMID: 30900195 RESULT

• 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.

  PMID: 34917419 RESULT

• 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.

  PMID: 31650412 RESULT

Study Officials

• Karen A Kuhlthau, PhD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Model Details: We ran two groups of a resiliency intervention.

Study Record Dates

• First Submitted: June 25, 2022
• First Posted: September 10, 2022
• Study Start: May 6, 2022
• Primary Completion: September 29, 2022
• Study Completion: October 20, 2022
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)