NCT04607616

Brief Summary

The purpose of this study is to assess the effect of Interactive Guidance Therapy with video feed back (IGT) of parent and child with Autism Spectrum Disorder, under three years of age, using a Single Case Experimental Design (SCED) with multiple baseline across subjects, multicentric, randomized, with multiple replications, blinded scored

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

October 29, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

March 26, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 23, 2022

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
Last Updated

May 6, 2026

Status Verified

April 1, 2026

Enrollment Period

1.2 years

First QC Date

July 1, 2020

Last Update Submit

April 30, 2026

Conditions

Autism Spectrum Disorders

Keywords

Autism Spectrum DisordersInteractive guidance therapyVideo feed-back

Outcome Measures

Primary Outcomes (2)

  • Percentage of time spent in a joint attention situation

    Coordinated Joint Attention (COJ) rate is evaluated during the parents-child play-time

    Up to 15 months

  • Percentage of time spent in a joint attention situation

    Supported Joint Attention (SUJ) rate is evaluated during the parents-child play-time

    Up to 15 months

Secondary Outcomes (15)

  • Parent-child interactive features/ joint attention

    Up to 15 months

  • Parent-child interactive features / DCMA scale

    Up to 15 months

  • Parent-child interactive features / Parental synchrony

    Up to 15 months

  • Parent-child interactive features / Communication

    Up to 15 months

  • Parent-child interactive features / Initiation of communication

    Up to 15 months

  • +10 more secondary outcomes

Study Arms (6)

3 baselines sessions Treatment As Usual (TAU)

EXPERIMENTAL

Patients received 3 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

4 baselines sessions TAU

EXPERIMENTAL

Patients received 4 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

5 baselines sessions TAU

EXPERIMENTAL

Patients received 5 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

6 baselines sessions TAU

EXPERIMENTAL

Patients received 6 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

7 baselines sessions TAU

EXPERIMENTAL

Patients received 7 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

8 baselines sessions TAU

EXPERIMENTAL

Patients received 8 baseline sessions before interactive guidance therapy

Behavioral: Baseline sessions TAUBehavioral: Interactive guidance therapyDiagnostic Test: Developmental and diagnostic assessmentsBehavioral: Developmental assessment -Parental scalesBehavioral: Qualitative analysis

Interventions

Baseline sessions TAUBEHAVIORAL

TAU consists of sessions lasting around one/one and a half hour ; the consultant is practicing as usual. The interventions focus on child's behavior, parent infant relationship, with moments of play with the child, advices, informations about child development and Autism.

3 baselines sessions Treatment As Usual (TAU)4 baselines sessions TAU5 baselines sessions TAU6 baselines sessions TAU7 baselines sessions TAU8 baselines sessions TAU
Interactive guidance therapyBEHAVIORAL

The objective is to reinforce the identification, deciphering, interpretation, and answer to child's signals by the parent, in order to to promote a synchronous and attuned response to the child's needs. Sessions last around one/one and a half hour. Parent plays 7-10 minutes with the child, in the presence of the therapist, with toys chosen according to the child's developmental stage. Then therapist proposes an immediate viewing of the play session. The therapist selects short moments of positive interaction. He has determined a " focus ", depending on the play, previous sessions, the child's difficulties and parent's interventions. He accompanies, guides and supports the parent to describe the interaction, the alternance in play, joint attention, shared affect, in a co-construction: the parent discovers the child's and his own skills.

3 baselines sessions Treatment As Usual (TAU)4 baselines sessions TAU5 baselines sessions TAU6 baselines sessions TAU7 baselines sessions TAU8 baselines sessions TAU
Developmental and diagnostic assessmentsDIAGNOSTIC_TEST

MSEL, CARS, ECAR, CIM10, DMS5, ADOS, ADIR

3 baselines sessions Treatment As Usual (TAU)4 baselines sessions TAU5 baselines sessions TAU6 baselines sessions TAU7 baselines sessions TAU8 baselines sessions TAU
Developmental assessment -Parental scalesBEHAVIORAL

Vineland II, IFDC, IDE

3 baselines sessions Treatment As Usual (TAU)4 baselines sessions TAU5 baselines sessions TAU6 baselines sessions TAU7 baselines sessions TAU8 baselines sessions TAU
Qualitative analysisBEHAVIORAL

Interpretative Phenomenological Analysis. Parents' semi structured interview about the Interactive Guidance experience. Qualitative analysis of transcripts (recurrent themes, meta themes).

3 baselines sessions Treatment As Usual (TAU)4 baselines sessions TAU5 baselines sessions TAU6 baselines sessions TAU7 baselines sessions TAU8 baselines sessions TAU

Eligibility Criteria

Age18 Months - 3 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • months to 3 years child at screening
  • Child with a diagnosis of Autism Spectrum Disorder (DSM 5) or pervasive Developmental Disorder (ICD 10)
  • Child with ADI R and ADOS-2 fulfilling the criteria for TSA / PDD at diagnosis
  • Developmental age \> 12 months in motility with the Brunet-Lézine test
  • Child with availability of parent most present in daily life, only this parent participating directly in play sessions
  • Signed Informed consent form by both parents
  • Patient affiliated to the health insurance system

You may not qualify if:

  • Level of language in French of parents insufficient to benefit from the care and fill in the questionnaires
  • Psychiatric parental pathology interfering with interactions with the child, qualitatively assessed by the referring psychiatrist
  • Severe sensory illness of the child (blindness, deafness, degenerative disease)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Saint Eloi

Montpellier, 34000, France

Location

Hôpital Ville Evrard

Montreuil, 93100, France

Location

Hôpital Pitié Salpétriere

Paris, 75013, France

Location

Hôpital Necker Enfants Malades

Paris, 75015, France

Location

Related Publications (3)

  • 1. McDonough S. Interaction guidance. Treat Parent-infant Relatsh Probl Strateg Interv. 2004;79-96.

    BACKGROUND

  • 2. McDonough SC. Promoting positive early parent-infant relationships through interaction guidance. Child Adolesc Psychiatr Clin N Am. 1995;4(3):661-72.

    BACKGROUND

  • Rusconi-Serpa S, Sancho Rossignol A, McDonough SC. Video feedback in parent-infant treatments. Child Adolesc Psychiatr Clin N Am. 2009 Jul;18(3):735-51. doi: 10.1016/j.chc.2009.02.009.

    PMID: 19486848BACKGROUND

MeSH Terms

Conditions

Autism Spectrum Disorder

Interventions

Growth and Development

Condition Hierarchy (Ancestors)

Child Development Disorders, PervasiveNeurodevelopmental DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Physiological Phenomena

Study Officials

  • Benoit QUIROT, MD

    EPS Ville Evrard

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 1, 2020

First Posted

October 29, 2020

Study Start

March 26, 2021

Primary Completion

May 23, 2022

Study Completion

May 1, 2026

Last Updated

May 6, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(4)