Clinical trial NCT05940168: Internet-delivered ACT (I-Navigator ACT) for Parents of Children With Disabilities
Official title: Feasibility, Effectiveness and Qualitative Experiences of Internet-delivered ACT for Parents of Children With Disabilities
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
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
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Region Stockholm
name: Forte
name: Stiftelsen Frimurarna Barnhuset
First posted: 2023-07-11
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria (in all studies):

* 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

Primary outcomes:
measure: Study 1: Treatment completion rate
timeFrame: Participants are assessed during the 10-12 weeks long treatment.
measure: Study 2: Changes in parental psychological flexibility and experiential acceptance
timeFrame: 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)
measure: Study 3: Experiences of participating in an internet-delivered ACT treatment for parents
timeFrame: The interviews are conducted after (circa 3 months) parents have participated in the I-Navigator ACT treatment.
Secondary outcomes:
measure: Study 1: Changes in general stress and parental stress
timeFrame: 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)
measure: Study 1: Changes in depression and anxiety symptoms
timeFrame: 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)
measure: Study 1: Changes in mindfulness-based skills
timeFrame: 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)
measure: Study 1: Changes in psychological flexibility and experiential acceptance
timeFrame: 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)
measure: Study 1: Change in child's difficulties and the impact of these difficulties on the child's family
timeFrame: 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)
measure: Study 2: Changes in general stress and parental stress
timeFrame: 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)
measure: Study 2: Changes in depression and anxiety symptoms
timeFrame: 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)
measure: Study 2: Changes in mindfulness-based skills
timeFrame: 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)
measure: Study 2: Changes in psychological flexibility and experiential acceptance
timeFrame: 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)
measure: Study 2: Change in child's difficulties and the impact of these difficulties on the child's family
timeFrame: 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:
measure: Study 1: Treatment Credibility Scale (TCS)
timeFrame: 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).
measure: Study 1: Current Life Situation Form (CLS)
timeFrame: 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)
measure: Study 1: Module Evaluation Form
timeFrame: Participants rate each of every ten modules after each module is completed during the 10-12 weeks of ongoing treatment.
measure: Study 2: Treatment Credibility Scale (TCS)
timeFrame: 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).
measure: Study 2: Current Life Situation Form (CLS)
timeFrame: 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)
measure: Study 2: Module Evaluation Form
timeFrame: Participants rate each of every ten modules after each module is completed during the 10-12 weeks of ongoing treatment.
measure: Study 2 (only): Session Evaluation Form
timeFrame: Participants rate each of every five group sessions after each session is completed during the 10-12 weeks of ongoing treatment.
Locations:
city: Stockholm
country: Sweden
facility: Habilitering & Hälsa
state: Region Stockholm
Study officials:
affiliation: Karolinska Institutet
name: Tatja Hirvikoski, PhD
role: PRINCIPAL_INVESTIGATOR
References: