Clinical Trials Logo

Clinical Trial Summary

This study aims to investigate the efficacy of guided self-help Acceptance Commitment Therapy (ACT) for adults who have a diagnosis for Autistic Spectrum Disorder (ASD) and are experiencing psychological distress (stress, anxiety or depression). This is a repeated measures design, using a single case experimental design (SCED) over a period of fourteen weeks. Each participant (n=8) with be asked to complete weekly measures and shortened measures every three days, while they read an ACT guided self-help bibliotherapy. For more information about the measures, please see outcome measure section. The ACT guided bibliotherapy will be administered to each participant on a weekly basis, over eight weeks. Participants will be asked to complete outcome measures at two week and at four weeks post intervention.


Clinical Trial Description

INTRODUCTION High levels of psychiatric co-morbidity have been found with adults who receive a diagnosis of Autistic Spectrum Disorder (ASD); including stress, anxiety, depression and OCD. Acceptance and Commitment Therapy (ACT) is a psychotherapeutic approach and is referred to as a "third wave" CBT. There have been over one hundred randomized control trials (RCTs) supporting the efficacy of ACT for different types of distress and severity. Researchers conducted an ACT based group, for students with ASD; the results indicated that levels of stress, hyperactivity and emotional distress were reduced in the treatment group, compared to classes as unusual. Results were maintained or improved at a two month follow up. However, little is still known about the efficacy of ACT for adults with ASD who experience. This research will indicate if guided ACT self-help facilitates increases psychological flexibility for adults with ASD, which is known to be less developed in people with ASD. Psychological flexibility mediates the experience of psychological distress, for example depression, anxiety and stress, which are known to be highly prevalent in this population. Currently, there are mixed results in relation to effectiveness of CBT; very few researchers have measured the effectiveness of ACT to increase psychological flexibility in an adult ASD population and determine if this mediates a reduction in psychological distress. PURPOSE OF THE STUDY This research will add to the knowledge about how ACT guided self-help can be adapted for adults with ASD. It will give results on how effective ACT guided self-help is in supporting adults with ASD, to increase psychological flexibility and reduce psychological distress. If guided ACT self-help intervention is effective; this will help increase access and availability of psychological intervention for people with ASD, specifically in relation to associated difficulties in social communication and interaction. PRIMARY OBJECTIVE To examine whether an ACT bibliotherapy intervention, for adults with a diagnosis of ASD who experience psychological distress, increases psychological flexibility. SECONDARY OBJECTIVE(S) To examine whether psychological flexibility mediates changes in; personally-identified therapeutic goals, increasing psychological wellbeing and decreasing anxiety, stress and depression. STUDY DESIGN This is a repeated measures design, using a single case experimental design (SCED). Each participant with be asked to complete weekly measures and shortened measure every three days, please see the outcome measures section for more details of the measures and timeframes. Weekly data collection will last for approximately 10 weeks (baseline and intervention phase), with a two week and four week follow-up. DATA ANALYSIS SCED data will be predominantly analysed using visual analysis. Data will be plotted onto graphs to analyse the direction of the data (trend), the "magnitude" (level) and the variability of the data (stability). To find out if change from pre and post scores is reliable, a Reliable Change Index (RCI) will be conducted. To determine if any change is clinically significant, a Clinically Significant Criterion (CSC) will be conducted. The data will be analysed at the University of Lincoln and Students home (via secured sites). The data will be analysed using Excel software. No interim analysis is planned for safety, efficacy or management purposes. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04376151
Study type Interventional
Source University of Lincoln
Contact Megan J Mellor
Phone 07870449692
Email 16662521@students.lincoln.ac.uk
Status Recruiting
Phase N/A
Start date September 1, 2020
Completion date August 20, 2022

See also
  Status Clinical Trial Phase
Terminated NCT03715166 - Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children and Adolescents Aged From 7 to Less Than 18 Years Old With Autism Spectrum Disorder Phase 3
Not yet recruiting NCT05182697 - SCI-210 in the Treatment of Children and Young Adults With AutismEvaluate the Safety, Tolerability and Efficacy of SCI-210 in Children With Autism Spectrum Disorder (ASD) N/A
Completed NCT02803801 - Build Your Parenting Toolkit: Guiding Children to Become Flexible Thinkers N/A
Terminated NCT03715153 - Efficacy and Safety of Bumetanide Oral Liquid Formulation in Children Aged From 2 to Less Than 7 Years Old With Autism Spectrum Disorder. Phase 3
Terminated NCT01592773 - Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Phase 2
Withdrawn NCT01395953 - Double-blind Trial of Buspirone for the Treatment of Anxiety in Youth With Autism Spectrum Disorders Phase 2
Terminated NCT01248130 - Omega-3 Fatty Acids Monotherapy in Children and Adolescents With Autism Spectrum Disorders Phase 2
Completed NCT04860986 - A Repeatability and Reproducibility Study of the EarliPointâ„¢ Device
Active, not recruiting NCT04299464 - A 12-Week Placebo-Controlled Study to Investigate the Efficacy, Safety, and Tolerability of RO7017773 in Participants Aged 15-45 Years With Autism Spectrum Disorder (ASD) Phase 2
Recruiting NCT03392870 - Evaluation of a Clinical Transitional Program in Autism N/A
Completed NCT01592786 - An Open-Label Safety Study of Memantine in Pediatric Patients With Autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Phase 2
Enrolling by invitation NCT05187377 - A Controlled Trial of Growth Hormone in Phelan-McDermid Syndrome and Idiopathic Autism Phase 2
Completed NCT04631432 - Choice Switching and Autism
Recruiting NCT04578756 - Open-Label, Flexible-dose Study to Evaluate the Long-Term Safety and Tolerability of Cariprazine in the Treatment of Pediatric Participants With Schizophrenia, Bipolar I Disorder, or Autism Spectrum Disorder Phase 3
Completed NCT02037022 - Pivotal Response Treatment Package for Young Children With Autism N/A
Completed NCT01854346 - Social Skills Group Training ("KONTAKT") for Children and Adolescent With High-functioning Autism Spectrum Disorders N/A
Active, not recruiting NCT04895215 - AB-2004 in Treatment of Irritability Associated With Autism Spectrum Disorder (ASD) Phase 2
Active, not recruiting NCT03426826 - The Gut-Brain Study Phase 1
Completed NCT02384486 - Efficacy of Training Programme to Reduce Stress N/A
Completed NCT00614198 - ScanBrit Dietary Intervention in Autism Phase 2