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

June 28, 2023 updated by: Karen Kuhlthau, Massachusetts General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feedback regarding adapted intervention acceptability by session
Time Frame: 6 months
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)
Time Frame: 8 weeks
Feasibility will be assessed using attendance (i.e. 6/8 sessions).
8 weeks
Feasibility (data collection number completing study surveys)
Time Frame: 3 months
Feasibility will be assessed using number of dads completing study surveys
3 months
Acceptability helpfulness ratings of sessions and aspects of program
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2022

Primary Completion (Actual)

September 29, 2022

Study Completion (Actual)

October 20, 2022

Study Registration Dates

First Submitted

June 25, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 28, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 2022P000562

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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