Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities

NCT ID: NCT05940168

Last Updated: 2023-07-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2023-11-30

Brief Summary

The purpose of the project is to evaluate the feasibility, acceptability, and effectiveness of the internet-delivered Acceptance and Commitment Therapy treatment (I-Navigator ACT) for parents who experience stress, distress, depression or anxiety that may be associated with being a parent of a child with disabilities. The project consists of three studies:

Study 1: An open feasibility trial in which parents participate in an individual, clinician-supported internet-delivered Acceptance and Commitment Therapy treatment.

Study 2: A randomized controlled trial in which participants are randomly assigned either:

1. Navigator ACT group treatment, where parents participate in an Acceptance and Commitment Therapy group together with other parents, led by two group leaders, or

2. I-Navigator ACT internet-delivered Acceptance and Commitment Therapy treatment, where the parent participates on their own, coached by a clinician via a message function.

Study 3: A qualitative study in which a smaller sample of parents from the open feasibility trial participate in semi-structured interviews. The interviews take place after the parents have completed I-Navigator ACT.

All three studies are conducted in a clinical health care context.

Detailed Description

Internet Navigator ACT (I-Navigator ACT) is an individual, internet-delivered Acceptance and Commitment Therapy (ACT) treatment, adapted from the manualized ACT group Navigator ACT for parents of children with disabilities. The purpose of I-Navigator ACT is to provide a treatment option that isn't bound by geography, especially beneficial for patients who have limited access to in-person support and care. I-Navigator ACT was developed with a co-creation approach, which included pilot testing with a small group of parents to gather their detailed feedback. Their feedback was considered for refining the treatment.

I-Navigator ACT consists of ten online modules with different themes based on ACT processes. Participants receive weekly written support from an experienced clinician (coach), via a message function. The program is available through the Swedish national platform for internet-delivered treatments (1177.se).

There are three studies planned in this project. The first study (Study 1) will be conducted as a open feasibility trial, in which all participating parents after enrolment and inclusion (via telephone or video call) will be allocated to the I-Navigator ACT treatment. The main purpose of this study is to evaluate feasibility and acceptability of the treatment. Feasibility is measured through treatment completion, treatment credibility and expectation, as well as treatment satisfaction. Preliminary outcomes regarding effectiveness will also be evaluated in this study. Participants are being assessed at pre-treatment, post-treatment, and three months post-treatment.

The second study (Study 2) will be conducted as a randomized controlled trial with two treatment arms. The randomized controlled trial is conducted to evaluate the effectiveness of the I-Navigator ACT treatment compared to the Navigator ACT group treatment. After enrolment and screening via telephone or video call, eligible participants are invited to an information meeting. Once the participants have given their informed consent and completed pre-treatment assessments, they are randomly assigned either the five-session Navigator ACT group, or the I-Navigator ACT treatment. The treatments run parallel during the same semester, and participants are being assessed at the same time points (pre-treatment, post-treatment, and three months post treatment). Effectiveness will be evaluated through the primary outcome measure of acceptance and action-based skills, and secondary outcome measures parental stress, depression and anxiety symptoms, experiential avoidance, mindfulness-based skills, and parent-rated child behavioral problems.

The third and final study (Study 3) will be a qualitative study based on semi-structured interviews, and will be utilizing a thematic content analysis. The interviews will mainly focus on the experience of participating in an internet-delivered ACT treatment for parents.

Data collection commenced in early spring of 2021 (beginning with the open feasibility study) and is projected to be completed by November 2023. N = 32 participants have been allocated to treatment in the open feasibility study, whereas n = 134 participants have been allocated to treatment in the RCT. Nine parents have participated in qualitative interviews.

Conditions

Parents; Stress, Psychological; Anxiety; Depression; Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Hyperactivity Disorder; Intellectual Disability; Physical Disability; Traumatic Brain Injury

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Navigator ACT group

This is a manualized Acceptance and Commitment Therapy group-intervention for 8-16 parents of children with disabilities. The intervention consists of five group sessions with different themes, as well as a booster-session at three months after the fifth session. The intervention is held by two group leaders.

Group Type: ACTIVE_COMPARATOR

Navigator ACT group

Intervention Type: BEHAVIORAL

The intervention is a five session Acceptance and Commitment Therapy group treatment for stressed and distressed parents of children with disabilities. All five sessions have different themes and are held by two group leaders. Sessions are around two and a half hours long. Homework is given between sessions.

I-Navigator ACT

This intervention is an internet-delivered version of the manualized Acceptance and Commitment Therapy group. The internet-delivered version is given as an individual treatment via a secure online treatment platform. It consists of ten separate chapters or modules. The duration of the intervention is 10-12 weeks, with a individual follow up-session by phone or video at three months after completion.

Group Type: EXPERIMENTAL

I-Navigator ACT

Intervention Type: BEHAVIORAL

The intervention is an internet-delivered ten module Acceptance and Commitment Therapy treatment program for stressed and distressed parents of children with disabilities. The contents of the program is mostly text based, but also includes videos, mindfulness exercises and written exercises, as well as homework between modules.

Interventions

I-Navigator ACT

The intervention is an internet-delivered ten module Acceptance and Commitment Therapy treatment program for stressed and distressed parents of children with disabilities. The contents of the program is mostly text based, but also includes videos, mindfulness exercises and written exercises, as well as homework between modules.

Intervention Type: BEHAVIORAL

Navigator ACT group

The intervention is a five session Acceptance and Commitment Therapy group treatment for stressed and distressed parents of children with disabilities. All five sessions have different themes and are held by two group leaders. Sessions are around two and a half hours long. Homework is given between sessions.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a parent of at least one child (4-17 years of age) with any or several of the following disabilities: autism spectrum disorder, attention deficit hyperactivity disorder, intellectual disability, physical disability (eg cerebral palsy), traumatic brain injury and/or a profund and multiple intellectual disability (PMID)
• Experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
• Having access to a personal computer or tablet with a stable internet connection
• In Study 2 (RCT) also: being able to participate in the group treatment OR the internet-delivered treatment

Exclusion Criteria

• Currently experiencing a serious mental disorder (eg ongoing psychosis, acute suicidal behaviours) or currently being treated at an in-patient mental health facility
• Not experiencing stress, distress, depression and/or anxiety that to some extent may be associated with being a parent of a child with a disability
• Not being able to read, write or speak the Swedish language
• Not being able to participate in all planned sessions
• Not having access to a personal computer or tablet with a stable internet connection
• In Study 2 (RCT) also: not being able to participate in the group treatment OR the internet-delivered treatment

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Region Stockholm

OTHER_GOV

Sponsor Role: collaborator

Forte

INDUSTRY

Sponsor Role: collaborator

Stiftelsen Frimurarna Barnhuset

UNKNOWN

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Tatja Hirvikoski

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tatja Hirvikoski, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

Habilitering & Hälsa

Stockholm, Region Stockholm, Sweden

Countries

Sweden

Other Identifiers

I-Navigator ACT

Identifier Type: -

Identifier Source: org_study_id