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

NCT05940168 | Unknown

• 1 other identifier: I-Navigator ACT
• Study Type: interventional
• Target: 134
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

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

Keywords

Acceptance and Commitment Therapy; Mindfulness; Experiential avoidance; Autistic children; Parental stress; Disability; Mental health; Telehealth; Internet delivered treatment; Randomized controlled trial; Group therapy; Families; Qualitative study; Interviews

Outcome Measures

Primary Outcomes (3)

• Study 1: Treatment completion rate

  In this feasibility study (study 1), treatment completion is defined as completing 7 out of 10 intervention sessions/modules. The benchmark for good feasibility is 75% of participants completing the treatment.

  Participants are assessed during the 10-12 weeks long treatment.

• Study 2: Changes in parental psychological flexibility and experiential acceptance

  Parental Acceptance and Action Questionnaire (PAAQ), a scale that targets psychological flexibility and experiential acceptance in the parenting context, i.e., measures to which extent parents' accept inner experiences related to parenting and the readiness to take appropriate and needed action in parenting (commitment to values-based actions). This was originally a 19-item scale.

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 3: Experiences of participating in an internet-delivered ACT treatment for parents

  The semi-structured interviews with parents after they have participated in the I-Navigator ACT treatment are based on the following seven interview questions: 1. How was your experience participating in I-Navigator ACT? 2. What aspects of the treatment did you appreciate? 3. What aspects of the treatment did you appreciate less? 4. Have you noticed any changes in your life, or everyday life after going through the treatment? Could you describe them? 5. What aspects of the treatment do you think will be useful to you? 6. What would you like to change about the treatment? 7. If you were given the possibility to participate in the treatment but in a different format, eg in a group context, or one-on-one with your care provider in a physical room, what do you think would have been different, and what would be quite similar to your experience? How do you think you would find that?

  The interviews are conducted after (circa 3 months) parents have participated in the I-Navigator ACT treatment.

Secondary Outcomes (10)

• Study 1: Changes in general stress and parental stress

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 1: Changes in depression and anxiety symptoms

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 1: Changes in mindfulness-based skills

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 1: Changes in psychological flexibility and experiential acceptance

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 1: Change in child's difficulties and the impact of these difficulties on the child's family

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

Other Outcomes (7)

• Study 1: Treatment Credibility Scale (TCS)

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), and post-treatment, at the time of completing the intervention (T2).

• Study 1: Current Life Situation Form (CLS)

  Participants are assessed at the time of inclusion, circa two weeks prior to the beginning of the intervention (T1), post-treatment, at the time of completing the intervention (T2), and at around three months after completing the intervention (T3)

• Study 1: Module Evaluation Form

  Participants rate each of every ten modules after each module is completed during the 10-12 weeks of ongoing treatment.

Study Arms (2)

Navigator ACT group

ACTIVE COMPARATOR

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.

Behavioral: Navigator ACT group

I-Navigator ACT

EXPERIMENTAL

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.

Behavioral: I-Navigator ACT

Interventions

I-Navigator ACT 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.

I-Navigator ACT

Navigator ACT group 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.

Navigator ACT group

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Karolinska Institutet: lead
• Region Stockholm: collaborator
• Forte: collaborator
• Stiftelsen Frimurarna Barnhuset: collaborator

Study Sites (1)

Habilitering & Hälsa

Stockholm, Region Stockholm, 104 62, Sweden

Location

MeSH Terms

Conditions

Stress, Psychological; Anxiety Disorders; Depression; Neurodevelopmental Disorders; Autism Spectrum Disorder; Attention Deficit Disorder with Hyperactivity; Intellectual Disability; Brain Injuries, Traumatic; Psychological Well-Being

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders; Child Development Disorders, Pervasive; Attention Deficit and Disruptive Behavior Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Personal Satisfaction

Study Officials

• Tatja Hirvikoski, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Masking at baseline for both participant and care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: The main study in this project (Study 2) is a randomized controlled trial in which the participants are randomly assigned either a group intervention (Navigator ACT), or an internet-delivered ACT intervention (I-Navigator ACT). No treatment-as-usual (TAU) or wait-list control groups are included in this model.

Study Record Dates

• First Submitted: July 3, 2023
• First Posted: July 11, 2023
• Study Start: February 1, 2021
• Primary Completion: November 30, 2023
• Study Completion: November 30, 2023
• Last Updated: July 11, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)