Autism Spectrum DisorderTAFFNCT04722783
Effect of ESDM and PCIT-A in Autism Spectrum Disorder
A study testing Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Early Start Denver Model (ESDM) intervention and 1-hour ESDM in people with Autism Spectrum Disorder, run by Bruno Rhiner at 1 site in Switzerland.
Trial summary
Children with ASD often show disruptive behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. Read more about this study
- Who is it for?
- Ages 24 to 59 months
- Conditions the study is for
- Autism Spectrum Disorder
- What is being tested?
- Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Early Start Denver Model (ESDM) intervention and 1-hour ESDM
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteSwitzerland
- Study dates
- 14 Jan 2021to 21 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 59 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASD level 1 to 3
- Time commitment of at least one parent (including homework and traveling time)
- Willingness of one parent to be the study informant over the whole study period
Who cannot join
- Insufficient German language skills of both parents to participate in the intervention
- Severe hearing or visual impairment
- Attention deficit hyperactivity disorder
- Epilepsy
- Rett syndrome
- Other rare, severe neurological disorders that interfere with therapy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Psychiatric Services of Thurgovia
Münsterlingen, Thurgau, 8596
About this study
Official title: Effect of Early Start Denver Model and Autism-adapted Parent-Child Interaction Therapy on Autism Symptoms and Disruptive Behavior in Toddlers and Preschool Children with Autism Spectrum Disorder (TAFF Pilot Study)
Children with ASD often show disruptive behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently PCIT was adapted for children with autism spectrum disorder (PCIT-A). ESDM is an evidence-based treatment for ASD but has not been investigated in combination with PCIT-A.
As primary aims, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.
Read the detailed description
Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder with recognizable symptoms often beginning between one and two years of age and an estimated prevalence of about 0.6%. Both social communication deficits, and restrictive and repetitive behavior depict the core symptoms of ASD.
ESDM is an evidence-based treatment for ASD. A recent meta-analysis comprising 12 studies show favorable effects of ESDM on cognition and language with a moderate effect size, in contrast to control groups. ESDM showed to become cost-efficient within a few years after treatment as a result of less use of other health care services in the years following the intervention.
Children with ASD often show disruptive behaviors such as angry outbursts, irritability, aggressive and oppositional behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently, PCIT was adapted for children with autism spectrum disorder (PCIT-A).
As primary aims of the so-called TAFF (Tagesklinik für Autismus und Frühförderung [Day Clinic for Autism and Early Intervention]) pilot study, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.
- Conditions
- Autism Spectrum Disorder
- Being tested
- Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Early Start Denver Model (ESDM) intervention, 1-hour ESDM, Early special needs education (ESNE)
- Keywords
- Parent-Child Interaction Therapy, Early Start Denver Model, Autism Spectrum Disorder, Disruptive behavior, Autism Symptoms, Toddlers, Preschool children
- Medical subject headings
- Autism Spectrum Disorder, Problem Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)Behavioural
Also called Intervention I
PCIT is a behavioral family therapy approach emphasizing the integration of traditional child play therapy techniques within a behavioral framework of parent-child therapy and was developed by Eyberg (1988). It is based on attachment theory, social learning theory, and parenting styles theory. Recently, the intervention was adapted to children with ASD by our team (McNeil, Quetsch, \& Anderson, 2019). PCIT-A will last about 8 months, 1 day per week, 60min per day (see Study Protocol, Fig. 2).
Early Start Denver Model (ESDM) interventionBehavioural
Also called Intervention II
ESDM intervention provides intensive teaching by trained therapists and parents during natural play and relationship-focused daily routines. It is evidence-based and uses principles of developmental psychology and applied behavior analysis. It was designed for toddlers and preschoolers with autism spectrum disorder by Rogers and Dawson (2010). The first intensive part of ESDM intervention (20h per week) will last 40 weeks of intervention within a period of 12 months. It includes 2 days per week for 6h a day clinic therapy, and 5 days per week for 1h homework tasks, and 2 days per week for 1.5h an early special needs education at home. After the first 12 months, children receive the second lower intensity part of ESDM (7 hours per week). It includes 1 days every two weeks 1h day clinic therapy, and 5 days per week for 1h homework tasks, and 1 days per week for 1.5h an early special needs education at home (see Study Protocol, Fig. 2).
1-hour ESDMBehavioural
Also called Active control for Intervention I
The active control group for PCIT-A stays in the ESDM day clinic therapy for the 12 hours per week while the PCIT-A group will receive 11 hours of ESDM day clinic therapy and 1 hour PCIT-A per week (see Study Protocol, Fig. 2).
Early special needs education (ESNE)Behavioural
Also called Active control for Intervention II
The wait-list control group will receive early special needs education. It consists of a 90-minute visit at participants' homes once a week by an employee educated in early special needs education. As soon as space in ESDM is available children will receive the ESDM intervention (stepped-wedge design, see Study Protocol, Fig. 2).
| Study group | Role | What they receive |
|---|---|---|
| ESDM and PCIT-A | Experimental | Participants in this arm receive 2 years ESDM and after 4 months PCIT-A for 8 months (see Study Protocol, Figure 2). Receives: Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A); Behavioral: Early Start Denver Model (ESDM) intervention |
| ESDM and active control for PCIT-A | Experimental | Participants in this arm receive 2 years ESDM and after 4 months 1h-ESDM as active control instead of 1h-PCIT-A for 8 months Receives: Behavioral: Early Start Denver Model (ESDM) intervention; Behavioral: 1-hour ESDM |
| PCIT-A and active control for ESDM | Experimental | Participants receive after 4 month PCIT-A for 8 months and early special needs education as an active control for ESDM. Receives: Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A); Behavioral: Early special needs education (ESNE) |
| Active control for ESDM and PCIT-A | Active comparator | Participants receive early special needs education as an active control for ESDM and PCIT-A. Receives: Behavioral: Early special needs education (ESNE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disruptive behavior change (for PCIT-A analysis)
Change from 4-month to 12-month Follow-Up (FU) in a composite score of Dyadic Parent-Child Interaction Coding System percentage compliance score and Eyberg Child Behavior Inventory intensity score (objective and parent-reported disruptive behavior; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Measured: Between 4-month and 12-month FU
Autism symptoms change (for ESDM analysis)
Change from baseline to 4-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
Measured: Between baseline to 4 month FU
Secondary outcomes (14)
Disruptive behavior long-term change (for PCIT-A analysis)
Change from 4-month to 24-month FU in a composite score of Dyadic Parent-Child Interaction Coding System percentage compliance score and Eyberg Child Behavior Inventory intensity score (objective and parent-reported disruptive behavior; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Measured: Between 4-month and 24-month FU
Autism symptoms change (for PCIT-A analysis)
Change from 4-month to 12-month FU and to 24-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
Measured: Between 4-month and 24-month FU
Developmental level change (for PCIT-A analysis)
Change from 4-month to 12-month and to 24-month FU in Entwicklungstest für Kinder von 6 Monaten bis 6 Jahren (engl.: Developmental Test for Children from 6 months to 6 years; behavioral and parent-reported measure, composite score of all 6 domains; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between 4-month and 24-month FU
Non-verbal Intelligence change (for PCIT-A analysis)
Change from 4-month to 12-month and to 24-month FU in Snijders-Oomen Non-verbal intelligence test revised 2-8 - puzzle subtest; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between 4-month and 24-month FU
Adaptive behavior change (for PCIT-A analysis)
Change from 4-month to 12-month and to 24-month FU in Vineland Adaptive Behavior Scale (composite score of the three domains communication, daily living skills, socialization; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between 4-month and 24-month FU
Social-emotional competence change (for PCIT-A analysis)
Change from 4-month to 12-month and to 24-month FU in Devereux Early Childhood Assessment (18 to 36 months version; (composite score of the three domains attachement/relationships, initiative, self-regulation; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between 4-month and 24-month FU
Parenting stress change (for PCIT-A analysis)
Change from 4-month to 12-month FU and to 24-month FU in Eltern-Belastungs-Inventar (engl.: Parenting Stress Index; composite score of 12 subscales, z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Measured: Between 4-month and 24-month FU
Autism symptoms long-term change (for ESDM analysis)
Change from baseline to 12-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
Measured: Between baseline and 12-month FU
Disruptive behavior change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in a composite score of Dyadic Parent-Child Interaction Coding System percentage compliance score and Eyberg Child Behavior Inventory intensity score (objective and parent-reported disruptive behavior; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Measured: Between baseline and 12-month FU
Developmental level change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in Entwicklungstest für Kinder von 6 Monaten bis 6 Jahren (engl.: Developmental Test for Children from 6 months to 6 years; behavioral and parent-reported measure, composite score of all 6 domains; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between baseline and 12-month FU
Non-verbal intelligence change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in Snijders-Oomen Non-verbal intelligence test revised 2-8 - puzzle subtest; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between baseline and 12-month FU
Adaptive behavior change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in Vineland Adaptive Behavior Scale (composite score of the three domains communication, daily living skills, socialization; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between baseline and 12-month FU
Social-emotional competence change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in Devereux Early Childhood Assessment (18 to 36 months version; (composite score of the three domains attachement/relationships, initiative, self-regulation; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a better outcome)
Measured: Between baseline and 12-month FU
Parenting stress change (for ESDM analysis)
Change from baseline to 4-month FU and from baseline to 12-month FU in Eltern-Belastungs-Inventar (engl.: Parenting Stress Index; composite score of 12 subscales, z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Measured: Between baseline and 12-month FU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start14 Jan 2021
- Primary completion18 Sep 2024
- Study completion21 Oct 2024
Why it stopped: The final study period was 1 year longer than anticipated but only 24 instead of 28 participants could be included. In the context of resource limitations and a sufficient sample size to assess the study aims, we prematurely stopped the pilot trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- This is a pilot, practical clinical trial with a single-blind, mixed randomized and non-randomized controlled factorial design within a monocentric setup
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruno Rhiner
- Sponsor type
- University, hospital or other
- Collaborators
- West Virginia University, University of Arkansas
- Responsible party
- Sponsor-investigator, Bruno Rhiner, Psychiatrische Dienste Thurgau
- Investigators
- Bruno Rhiner, Dr med, Principal investigator, Psychiatric Services of Thurgovia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722783
- Sponsor's protocol ID
- Protocol_PDT_010_TAFF
- Other IDs
- 2020-02787 (EKOS 20/223)
- Acronym
- TAFF
- Status last verified
- Jun 2024
- First submitted
- 20 Jan 2021
- Last updated
- 5 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not decided because of ethical considerations
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Early Start Denver Model and Autism-adapted Parent-Child Interaction Therapy on Autism Symptoms and Disruptive Behavior in Toddlers and Preschool Children with Autism Spectrum Disorder (TAFF Pilot Study)
- ClinicalTrials.gov ID
- NCT04722783
- Acronym / sponsor ID
- TAFF / Protocol_PDT_010_TAFF
- Conditions
- Autism Spectrum Disorder
- Keywords
- Parent-Child Interaction Therapy, Early Start Denver Model, Autism Spectrum Disorder, Disruptive behavior, Autism Symptoms, Toddlers, Preschool children
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The final study period was 1 year longer than anticipated but only 24 instead of 28 participants could be included. In the context of resource limitations and a sufficient sample size to assess the study aims, we prematurely stopped the pilot trial.
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Bruno RhinerUniversity, hospital or other
- Collaborators
- West Virginia University, University of Arkansas
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- 18 Sep 2024 (actual)
- Study completion
- 21 Oct 2024 (actual)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Children with ASD often show disruptive behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently PCIT was adapted for children with autism spectrum disorder (PCIT-A). ESDM is an evidence-based treatment for ASD but has not been investigated in combination with PCIT-A.
As primary aims, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.
Detailed description
Autism spectrum disorder (ASD) is a life-long neurodevelopmental disorder with recognizable symptoms often beginning between one and two years of age and an estimated prevalence of about 0.6%. Both social communication deficits, and restrictive and repetitive behavior depict the core symptoms of ASD.
ESDM is an evidence-based treatment for ASD. A recent meta-analysis comprising 12 studies show favorable effects of ESDM on cognition and language with a moderate effect size, in contrast to control groups. ESDM showed to become cost-efficient within a few years after treatment as a result of less use of other health care services in the years following the intervention.
Children with ASD often show disruptive behaviors such as angry outbursts, irritability, aggressive and oppositional behaviors. However, interventions that were specifically designed to improve these symptoms have not been sufficiently investigated, especially in children with level 1 to level 3 ASD. PCIT has large effects on externalizing behavior problems in children with disruptive behavior disorders. Recently, PCIT was adapted for children with autism spectrum disorder (PCIT-A).
As primary aims of the so-called TAFF (Tagesklinik für Autismus und Frühförderung [Day Clinic for Autism and Early Intervention]) pilot study, the investigators assess a) the effect of PCIT-A on disruptive behavior and b) the effect of ESDM on autism symptoms in toddlers and preschool children with ASD level 1 to 3. As secondary aims, the investigators evaluate a) the maintenance of the effect of PCIT-A one year after the end of intervention and b) the effect of both interventions on secondary outcomes (developmental level, intelligence, adaptive behavior, and parenting stress), c) the combined intervention effect of PCIT-A and ESDM depending on intervention overlap periods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
- Model description
- This is a pilot, practical clinical trial with a single-blind, mixed randomized and non-randomized controlled factorial design within a monocentric setup
| Arm | Type | Receives |
|---|---|---|
| ESDM and PCIT-A | Experimental | Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Behavioral: Early Start Denver Model (ESDM) interventionParticipants in this arm receive 2 years ESDM and after 4 months PCIT-A for 8 months (see Study Protocol, Figure 2). |
| ESDM and active control for PCIT-A | Experimental | Behavioral: Early Start Denver Model (ESDM) intervention, Behavioral: 1-hour ESDMParticipants in this arm receive 2 years ESDM and after 4 months 1h-ESDM as active control instead of 1h-PCIT-A for 8 months |
| PCIT-A and active control for ESDM | Experimental | Behavioral: Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Behavioral: Early special needs education (ESNE)Participants receive after 4 month PCIT-A for 8 months and early special needs education as an active control for ESDM. |
| Active control for ESDM and PCIT-A | Active comparator | Behavioral: Early special needs education (ESNE)Participants receive early special needs education as an active control for ESDM and PCIT-A. |
Who may qualify
- Ages
- 24 to 59 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASD level 1 to 3
- Time commitment of at least one parent (including homework and traveling time)
- Willingness of one parent to be the study informant over the whole study period
Key exclusion criteria (6 listed)
- Insufficient German language skills of both parents to participate in the intervention
- Severe hearing or visual impairment
- Attention deficit hyperactivity disorder
- Epilepsy
- Rett syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A)Also: Intervention IPCIT is a behavioral family therapy approach emphasizing the integration of traditional child play therapy techniques within a behavioral framework of parent-child therapy and was developed by Eyberg (1988). It is based on attachment theory, social learning theory, and parenting styles theory. Recently, the intervention was adapted to children with ASD by our team (McNeil, Quetsch, \& Anderson, 2019). PCIT-A will last about 8 months, 1 day per week, 60min per day (see Study Protocol, Fig. 2). | Behavioural | ESDM and PCIT-A, PCIT-A and active control for ESDM |
| Early Start Denver Model (ESDM) interventionAlso: Intervention IIESDM intervention provides intensive teaching by trained therapists and parents during natural play and relationship-focused daily routines. It is evidence-based and uses principles of developmental psychology and applied behavior analysis. It was designed for toddlers and preschoolers with autism spectrum disorder by Rogers and Dawson (2010). The first intensive part of ESDM intervention (20h per week) will last 40 weeks of intervention within a period of 12 months. It includes 2 days per week for 6h a day clinic therapy, and 5 days per week for 1h homework tasks, and 2 days per week for 1.5h an early special needs education at home. After the first 12 months, children receive the second lower intensity part of ESDM (7 hours per week). It includes 1 days every two weeks 1h day clinic therapy, and 5 days per week for 1h homework tasks, and 1 days per week for 1.5h an early special needs education at home (see Study Protocol, Fig. 2). | Behavioural | ESDM and PCIT-A, ESDM and active control for PCIT-A |
| 1-hour ESDMAlso: Active control for Intervention IThe active control group for PCIT-A stays in the ESDM day clinic therapy for the 12 hours per week while the PCIT-A group will receive 11 hours of ESDM day clinic therapy and 1 hour PCIT-A per week (see Study Protocol, Fig. 2). | Behavioural | ESDM and active control for PCIT-A |
| Early special needs education (ESNE)Also: Active control for Intervention IIThe wait-list control group will receive early special needs education. It consists of a 90-minute visit at participants' homes once a week by an employee educated in early special needs education. As soon as space in ESDM is available children will receive the ESDM intervention (stepped-wedge design, see Study Protocol, Fig. 2). | Behavioural | Active control for ESDM and PCIT-A, PCIT-A and active control for ESDM |
Primary outcome
Disruptive behavior change (for PCIT-A analysis)
Time frame: Between 4-month and 12-month FU
Change from 4-month to 12-month Follow-Up (FU) in a composite score of Dyadic Parent-Child Interaction Coding System percentage compliance score and Eyberg Child Behavior Inventory intensity score (objective and parent-reported disruptive behavior; z-standardized values with mean of 0 and SD of 1; probable range between -3 and +3; higher scores mean a worse outcome)
Autism symptoms change (for ESDM analysis)
Time frame: Between baseline to 4 month FU
Change from baseline to 4-month FU in Quantitative Checklist for Autism in Toddlers score (parent-reported, range: 0-100 points; higher scores mean a worse outcome)
14 secondary outcomes
Disruptive behavior long-term change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Autism symptoms change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Developmental level change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Non-verbal Intelligence change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Adaptive behavior change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Social-emotional competence change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Parenting stress change (for PCIT-A analysis)
Time frame: Between 4-month and 24-month FU
Autism symptoms long-term change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Disruptive behavior change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Developmental level change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Non-verbal intelligence change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Adaptive behavior change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Social-emotional competence change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Parenting stress change (for ESDM analysis)
Time frame: Between baseline and 12-month FU
Results and safety
The study was stopped early (reason given: The final study period was 1 year longer than anticipated but only 24 instead of 28 participants could be included. In the context of resource limitations and a sufficient sample size to assess the study aims, we prematurely stopped the pilot trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2024.
- Individual participant dataSharing planned: Undecided. It is not decided because of ethical considerations
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno Rhiner, Dr med principal investigator
Psychiatric Services of Thurgovia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parent-Child-Interaction Therapy adapted for children with autism spectrum disorder (PCIT-A), Early Start Denver Model (ESDM) intervention and 1-hour ESDM in people with Autism Spectrum Disorder, run by Bruno Rhiner at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The final study period was 1 year longer than anticipated but only 24 instead of 28 participants could be included. In the context of resource limitations and a sufficient sample size to assess the study aims, we prematurely stopped the pilot trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disruptive behavior change (for PCIT-A analysis) (time frame: Between 4-month and 12-month FU). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2024.