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

NCT ID: NCT05535348

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-06

Study Completion Date

2022-10-20

Brief Summary

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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

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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.

Conditions

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Stress Family Fathers

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

We ran two groups of a resiliency intervention.
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Relaxation Response Resiliency Program for Father of CYSHCN

Intervention Type BEHAVIORAL

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

Interventions

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Relaxation Response Resiliency Program for Father of CYSHCN

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Karen Kuhlthau

Professor, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen A Kuhlthau, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 30900195 (View on PubMed)

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.

Reference Type RESULT
PMID: 34917419 (View on PubMed)

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.

Reference Type RESULT
PMID: 31650412 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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2022P000562

Identifier Type: -

Identifier Source: org_study_id

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