Feasibility of a Virtual Mental Health Intervention for Children with Congenital Heart Disease

NCT06659302 | Not Yet Recruiting

• 1 other identifier: REB24-1232
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Children with congenital heart disease are at much higher risk for behavioral and emotional difficulties in early childhood and beyond 1. However, intervention programs aimed at this population are limited and few have explored the efficacy of behavioral parent training on child behavior and parent stress in children with CHD. Few evidence-based behavior intervention programs are available in the community for families of children with CHD and behavioral struggles and many families struggle to stick with long-term treatment given the multiple appointments and responsibilities that are often already associated in parenting children with chronic health conditions. As such, more targeted, shorter and more accessible interventions are very needed. Established internet-based treatments such as I-InTERACT-North, are particularly well-suited for adaptation to stepped-care delivery due to prior implementation success, readily adaptable intensity of online content and therapist contact. This study will evaluate whether I-InTERACT North is a feasible intervention to implement in a step-care model and whether it is acceptable to families and impacts behavior and family functioning.

Conditions

Congenital Heart Disease (CHD)

Keywords

heart; CHD; behavior; family stress

Outcome Measures

Primary Outcomes (5)

• Accrual Rate

  the proportion of invited participants who consent to participate

  56 weeks from first participant contact

• Dropout Rate

  the proportion of participants who drop out of the study during Step 1, 2 or 3

  70 weeks after contacting first participant

• Fidelity:

  the proportion of content covered from therapy protocols and questionnaires completed;

  70 weeks after contacting first participant

• Acceptability & Satisfaction

  the proportion of participants and therapists who rate the program as satisfactory or very satisfactory based on post-intervention; dropouts considered not-satisfied

  70 weeks after first participant contact

• Engagement & Adherence:

  the amount of time (in hours/weeks) to complete intervention steps will be estimated by parents and therapists (for steps 2 and 3), the number of sessions completed an adherence index (sessions completed/total sessions scheduled)

  70 weeks after first participant contact

Secondary Outcomes (4)

• Child behavior concerns and intensity baseline

  1 day after signing consent

• Parental stress baseline

  1 day after signing consent

• Child behavior at end of study

  up to 25 weeks after signing consent

• Parent stress end of study

  up to 25 weeks after signing consent

Study Arms (3)

Intro meeting

EXPERIMENTAL

Participants will be sent baseline questionnaires online through REDCap (Research Electronic Data Capture; see Appendix 1-email templates), a secure web application, and housed on a secure server. Participants will access a unique REDCap survey link via email to complete questionnaire measures after consenting to the study. After completion of the baseline questionnaires, participants will be connected with an I-InTERACT-North therapist for an Introductory Meeting to conduct a baseline elevation session. If participants do not wish to enroll in the full program, post-intervention questionnaires will be administered online through REDCap post step 1. If they wish to proceed to the full program, they will complete the questionnaires after step 2 or 3.

Behavioral: I-inTERACT North Step 1

Two sessions

EXPERIMENTAL

Step 2: Parents who were identified as high stress/behaviour on the baseline questionnaires and/or based on the introduction meeting in Step 1, will be invited to participate in the initial two therapist-guided I-InTERACT-North sessions that focus on family stress and positive parenting strategies. Each session includes both an online psychoeducational module and a video conferencing session with a therapist. Session frequency is subject to change based on parent schedule preference and availability. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). If they wish to proceed to the full program, they will complete the questionnaires after step 3.

Behavioral: I-inTERACT North step 2

Full Program

EXPERIMENTAL

Step 3: Families will be invited to participate in the full I-InTERACT-North program. The full program will provide an additional 5 online modules with live therapist videoconference coaching sessions. All sessions are strongly encouraged but for parents who do not complete the additional sessions, we will track what is completed and parents may still complete outcome measures. Based on previous work, average time of completion for the full program is 8-12 weeks. Each session will last 60 minutes and will be video recorded (with consent from the participants). Sessions will be delivered to parents using Zoom, a secure online video conferencing platform (https://zoom.us/). Before each session, parents will receive a meeting invitation link via email. After completing the program, participants will complete online questionnaires through REDCap. All participants will be invited to complete study follow-up questionnaires.

Behavioral: I-inTERACT North

Interventions

I-inTERACT North Step 1 BEHAVIORAL

Initial questionnaires completed followed by initial meeting with therapist for baseline evaluation.

Intro meeting

I-inTERACT North step 2 BEHAVIORAL

Two online modules completed by family plus two online zoom coaching sessions with therapist.

Two sessions

I-inTERACT North BEHAVIORAL

Full program will consist of an additional 5 sessions with online modules and virtual coaching sessions with therapist.

Full Program

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent provided
• parent of a child aged 3 to 9 years,
• parent reported concerns regarding their child's externalizing behaviour
• child is followed in cardiology clinic at Alberta Children's Hospital.
• parent is able to speak and read English.

You may not qualify if:

• Child is outside of age range of the program (\<3 or \> 9 years of age)
• Significant major medical issues requiring ongoing inpatient care
• Currently participating in an equivalent family/parent therapy program (e.g., Incredible Years Parenting Program (IYPP), Positive Parenting Program (Triple P))
• Inability to read/write and communicate in English
• Inability to consent or complete study measures electronically (online)

Sponsors & Collaborators

• University of Calgary: lead
• The Hospital for Sick Children: collaborator
• Alberta Children's Hospital: collaborator

Related Publications (5)

• Burek B, Ford MK, Hooper M, Green R, Kohut SA, Andrade BF, Ravi M, Sananes R, Desrocher M, Miller SP, Wade SL, Williams TS. Transdiagnostic feasibility trial of internet-based parenting intervention to reduce child behavioural difficulties associated with congenital and neonatal neurodevelopmental risk: introducing I-InTERACT-North. Clin Neuropsychol. 2021 Jul;35(5):1030-1052. doi: 10.1080/13854046.2020.1829071. Epub 2020 Oct 8.

  PMID: 33028141 BACKGROUND

• Wiggins TL, Sofronoff K, Sanders MR. Pathways Triple P-positive parenting program: effects on parent-child relationships and child behavior problems. Fam Process. 2009 Dec;48(4):517-30. doi: 10.1111/j.1545-5300.2009.01299.x.

  PMID: 19930436 BACKGROUND

• Masten AS, Hubbard JJ, Gest SD, Tellegen A, Garmezy N, Ramirez M. Competence in the context of adversity: pathways to resilience and maladaptation from childhood to late adolescence. Dev Psychopathol. 1999 Winter;11(1):143-69. doi: 10.1017/s0954579499001996.

  PMID: 10208360 BACKGROUND

• Antonini TN, Raj SP, Oberjohn KS, Cassedy A, Makoroff KL, Fouladi M, Wade SL. A pilot randomized trial of an online parenting skills program for pediatric traumatic brain injury: improvements in parenting and child behavior. Behav Ther. 2014 Jul;45(4):455-68. doi: 10.1016/j.beth.2014.02.003. Epub 2014 Feb 13.

  PMID: 24912459 BACKGROUND

• Cohen GH, Tamrakar S, Lowe S, Sampson L, Ettman C, Linas B, Ruggiero K, Galea S. Comparison of Simulated Treatment and Cost-effectiveness of a Stepped Care Case-Finding Intervention vs Usual Care for Posttraumatic Stress Disorder After a Natural Disaster. JAMA Psychiatry. 2017 Dec 1;74(12):1251-1258. doi: 10.1001/jamapsychiatry.2017.3037.

  PMID: 28979968 BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital; Behavior

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Marsha Vasserman, Psy.D.

CONTACT

403-955-5048; marsha.vasserman@ahs.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Neuropsychologist

Study Record Dates

• First Submitted: October 21, 2024
• First Posted: October 26, 2024
• Study Start: December 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: October 26, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share