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Completed

NCT Number: NCT06763614

Dog Assisted Therapy: Comparing Duration Treatments for Patients with Fetal Alcohol Spectrum Disorder

The objective of the present study was to assess the efficacy of a shorter version program of Dog Assisted Therapy (DAT) (8 sessions) compared to a longer version (16 sessions) for children and adolescents with Fetal Alcohol Syndrome (FASD). We evaluated the impact of DAT on social skills, internalizing and externalizing problems, quality of life, severity of the disorder and emotional well-being of parents. We conducted a randomized controlled trial in a cohort of 55 patients with FASD.

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Key information

Conditions

Fetal Alcohol Spectrum Disorders Alcohol-Induced Disorders Alcohol-Related Disorders Chemically-Induced Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Pregnancy Complications Substance-Related Disorders Urogenital Diseases

Age range

6 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

About this study

FASD can be classified into three subtypes. FAS is identified by (1) facial abnormalities, (2) growth deficits, abnormal brain development, or irregularities in neurophysiology, and (3) neurobehavioral issues. Partial Fetal Alcohol Spectrum Disorder (FASD) shares similarities but presents with fewer physical characteristics, while Alcohol-Related Neurobehavioral Disorder (ARND) solely exhibits neurobehavioral symptoms without facial anomalies.

Previous research has highlighted the effectiveness of psychological intervention programs focused on emotional regulation for individuals with FASD. Similarly, studies have emphasized the benefits of interventions targeting social skills. These interventions have been shown to result in reductions in externalizing behaviors, with social skills training specifically correlating with improvements in social competence and a decrease in problematic behaviors Recently a new form of behavioral therapy has been gaining popularity in improving the physical and mental health of young adults, known as Animal Assisted Therapy (AAT). Animal Assisted Therapy lays its foundation in human attachment theory and social cognitive theory where it is argued that animals can be potentially viewed as a transitional attachment object and thus aid to improve psychosocial functioning.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

all participants needed to have stable doses of medication for at least two months before the study and agree not to seek out any other psychiatric or psychological treatment during the study.

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Exclusion criteria

Patients who were not behaviorally stable, presented agressive behavior or required more intensive treatment (hospitalization or day hospital) were excluded.

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Treatment and study plan

Dog assisted therapy - animal interventions

Behavioral

Animal Assisted Therapy is when animals are used in goal directed treatment sessions. These goals are working emotionalaspects pf childres and adolescents with SAF

Primary outcomes

  1. Wechsler Intelligence Scale for Children

    Time frame: Once- Pre intervention week 1 - Post intervention in week 16

    Intellectual Quotient

  2. Child Behavior Checklist (CBCL by Achenbach)

    Time frame: Once- Pre intervention week 1 - Post intervention in week 16

    Internalizing/ Externalizing Symptoms maximum scores for symptom severity 113

  3. Social Skills Improvement System-Parent Form (SSIS-P)

    Time frame: Once- Pre intervention week 1 - Post intervention in week 16

    Social skills assessment - 0 to 60 max scotring

  4. KidScreen 27- 0 maximum 135 - highest severity symptoms at 135

    Time frame: Once- Pre intervention week 1 - Post intervention in week 16

    Quality of life assesment

  5. Clinical Global Impression Scale for Severity.0 to 7 (7 most severely ill).

    Time frame: Once- Pre intervention week 1 - Post intervention in week 16

    Severity of FASD symptoms

Sponsors and collaborators

Lead sponsor

Hospital Universitari Vall d'Hebron Research Institute

Other

Collaborators

  • Fundacion Probitas

Registry information

Official study title

A Randomised Controlled Study of Dog Assisted Therapy: Comparing a Short and a Long Version Program for Patients with Fetal Alcohol Spectrum Disorder.

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jan 8, 2025
Registry last updated
Jan 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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