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

Sponsor
Massachusetts General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05535348
Collaborator
(none)
12
1
1
3.8
3.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Relaxation Response Resiliency Program for Father of CYSHCN
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
12 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Evaluation of a Resiliency Program for Fathers of Children and Youth With Special Health Care Needs
Actual Study Start Date :
May 6, 2022
Anticipated Primary Completion Date :
Aug 31, 2022
Anticipated Study Completion Date :
Aug 31, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Open Pilot

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

Outcome Measures

Primary Outcome Measures

  1. Feedback regarding adapted intervention [6 months]

    Likert ratings on post-session feedback surveys (0 to 5 with 5 more acceptable), qualitative responses from exit interviews

Secondary Outcome Measures

  1. Feasibility (attendance) [8 weeks]

    Feasibility will be assessed using attendance (i.e. 6/8 sessions).

  2. Feasibility (data collection) [3 months]

    Feasibility will be assessed using number of dads completing study surveys

  3. Acceptability [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  1. 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)

  2. Age 18 or older

  3. Ability to participate in group, virtual sessions including access to computer, tablet, or smartphone and internet.

Exclusion Criteria:

Fathers will not be eligible if they are unable to speak or read English, are unwilling or unable to participate in the study, or are considered medically or otherwise unable to participate by the study PI.

There are no exclusion criteria with respect to ethnicity or socioeconomic status. To inform feasibility and acceptability, the investigators will document reasons for refusal and reasons why fathers are excluded (and will maintain this data in a de-identified way).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital

Investigators

  • Principal Investigator: Karen A Kuhlthau, PhD, Massachusetts General Hospital

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Karen Kuhlthau, Professor, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT05535348
Other Study ID Numbers:
  • 2022P000562
First Posted:
Sep 10, 2022
Last Update Posted:
Sep 10, 2022
Last Verified:
Sep 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Sep 10, 2022