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Compares treatment options for Adolescent Idiopathic Scoliosis
Official title Effectiveness of Acceptance and Commitment Therapy Versus Active Controls in Improving Psychological Functions of Parents and Children With Adolescent Idiopathic Scoliosis: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT05919459
What this study is testing
- What it's testing
- Systematic reviews revealed that Acceptance and Commitment Therapy (ACT) for parents had medium-to-large effect sizes in improving parental depression/anxiety (d \> 0.50), dysfunctional parenting styles (ds = 0.61-0.77), and small-to-large effect sizes in improving children's behavioral and emotional problems (ds = 0.25-0.84) in children/teenagers with various chronic diseases. A recent randomized controlled trial (RCT) showed that a web-based ACT program involving a coach providing semi-structured written feedback was significantly better than waitlist controls in improving the self-reported depression, anxiety, burnout, and psychological flexibility skills in parents of children/teenagers with chronic conditions (e.g., type 1 diabetes) up to 4 months post-treatment.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 10 to 60. Healthy volunteers may be eligible.
You may be able to join if
- of 168 parent-child dyads:
- the parent/guardian (henceforth "parents") aged between 25 and 60 years who is mainly responsible for taking care of a child with AIS (including the...
- the parent/guardian demonstrate at least mild anxiety (General Anxiety Disorder Scale scores \> 5) or mild depressive symptoms (Patient Health...
- the parent/guardian live with the index child aged between 10 and 17 years.
- the children have an orthopedist's diagnosis of AIS (Cobb angles of the major curve \> 10º).
You likely can't join if
- parents and/or children with psychological disorders or behavioral problems (e.g., attention deficit hyperactivity disorder) that require regular...
- children having undergone surgeries unrelated to AIS; or children with other types of scoliosis, or congenital diseases.
See the full eligibility criteria
- of 168 parent-child dyads:
- the parent/guardian (henceforth "parents") aged between 25 and 60 years who is mainly responsible for taking care of a child with AIS (including the scoliosis clinic follow-ups)
- the parent/guardian demonstrate at least mild anxiety (General Anxiety Disorder Scale scores \> 5) or mild depressive symptoms (Patient Health Questionnaire scores \> 5).
- the parent/guardian live with the index child aged between 10 and 17 years.
- the children have an orthopedist's diagnosis of AIS (Cobb angles of the major curve \> 10º).
- the children are managed conservatively or waiting for surgery scheduled more than six months later.
- both parents and children should reside in Hong Kong for at least another six months.
- both parents and children should be able to read/understand Chinese,
- both parents and children can be reachable via phone/email, and can access the Internet on their own computers, tablets, or smartphones.
- parents and/or children with psychological disorders or behavioral problems (e.g., attention deficit hyperactivity disorder) that require regular psychological/psychiatric interventions;
- children having undergone surgeries unrelated to AIS; or children with other types of scoliosis, or congenital diseases.
The study team makes the final eligibility decision.
Where it's taking place
- Hong Kong, Hong Kong
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 10 years to 60 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hong Kong, Hong Kong. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.