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OpenTrials
Completed

NCT Number: NCT05535348

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

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.

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Key information

Conditions

Stress Family Fathers

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Relaxation Response Resiliency Program for Father of CYSHCN

Behavioral

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Feasibility (attendance at 6/8 sessions)

    Time frame: 8 weeks

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

  2. Feasibility (data collection number completing study surveys)

    Time frame: 3 months

    Feasibility will be assessed using number of dads completing study surveys

  3. 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Sep 10, 2022
Registry last updated
Jul 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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